Neuromuscular Electrical Stimulation (NMES) in the Treatment of Muscle Atrophy:
This refers to the use of NMES in the treatment of disuse atrophy where nerve supply to the muscle is intact, including brain, spinal cord and peripheral nerves, and other non-neurological reasons for disuse atrophy. Some examples would be casting or splinting of a limb, contracture due to scarring of soft tissue as in burn lesions, and hip replacement surgery (until orthotic training begins).

Functional Electrical Stimulation (FES):
Functional electrical stimulation (FES) involves the use of an orthotic device or exercise equipment with microprocessor-controlled electrical muscular stimulation. These devices are being developed to restore function and improve health in patients with damaged or destroyed nerve pathways (eg, spinal cord injury [SCI], stroke, multiple sclerosis, cerebral palsy).

Populations	Interventions	Comparators	Outcomes
Individuals: With loss of hand and upper-extremity function due to spinal cord injury or stroke	Interventions of interest are: Functional electrical stimulation	Comparators of interest are: Standard of care	Relevant outcomes include: Functional outcomes Quality of life
Individuals: With chronic foot drop	Interventions of interest are: Functional electrical stimulation	Comparators of interest are: Standard of care Ankle-foot orthosis	Relevant outcomes include: Functional outcomes Quality of life
Individuals: With spinal cord injury at segments T4 to T12	Interventions of interest are: Functional electrical stimulation	Comparators of interest are: Standard of care	Relevant outcomes include: Functional outcomes Quality of life
Individuals: With spinal cord injury	Interventions of interest are: Functional electrical stimulation exercise equipment	Comparators of interest are: Standard of care	Relevant outcomes include: Symptoms Functional outcomes Quality of life

BACKGROUND

Functional Electrical Stimulation

Functional electrical stimulation (FES) is an approach to rehabilitation that applies low-level electrical current to stimulate functional movements in muscles affected by nerve damage. It focuses on the restoration of useful movements, like standing, stepping, pedaling for exercise, reaching, or grasping.

FES devices consist of an orthotic and a microprocessor-based electronic stimulator with 1 or more channels for delivery of individual pulses through surface or implanted electrodes connected to the neuromuscular system. Microprocessor programs activate the channels sequentially or in unison to stimulate peripheral nerves and trigger muscle contractions to produce functionally useful movements that allow patients to sit, stand, walk, cycle, or grasp. Functional neuromuscular stimulators are closed-loop systems that provide feedback information on muscle force and joint position, thus allowing constant modification of stimulation parameters, which are required for complex activities (eg, walking). These systems are contrasted with open-loop systems, which are used for simple tasks (eg, muscle strengthening alone); healthy individuals with intact neural control benefit the most from this technology.

Applications, described in more detail in the Rationale section, include upper-extremity grasping function after spinal cord injury and stroke, lifting the front of the foot during ambulation in individuals with foot drop, ambulation, and exercise for patients with spinal cord injury. Some devices are used primarily for rehabilitation rather than home use. This policy focuses on devices intended for home use.

Regulatory Status

A variety of FES devices have been cleared by the U.S. Food and Drug Administration (FDA) and are available for home use. Table 1 provides examples of devices designed to improve hand and foot function as well as cycle ergometers for home exercise. The date of the FDA clearance is for the first 510(k) clearance identified for a marketed device. Many devices have additional FDA clearances as the technology evolved, each in turn listing the most recent device as the predicate.

Table 1. Functional Electrical Stimulation Devices Cleared by the FDA

Device	Manufacturer	Device Type	Clearance	Date	Product Code
Freehand®	No longer manufactured	Hand stimulator		1997
NESS H200® (previously Handmaster)	Bioness	Hand stimulator	K022776	2001	GZC
MyndMove System	MyndTec	Hand stimulator	K170564	2017	GZI/IPF
ReGrasp	Rehabtronics	Hand stimulator	K153163	2016	GZI/IPF
WalkAide® System	Innovative Neurotronics (formerly NeuroMotion)	Foot drop stimulator	K052329	2005	GZI
ODFS® (Odstock Dropped Foot Stimulator)	Odstock Medical	Foot drop stimulator	K050991	2005	GZI
ODFS® Pace XL	Odstock Medical	Foot drop stimulator	K171396	2018	GZI/IPF
L300 Go	Bioness	Foot drop stimulator	K190285	2019	GZI/IPF
Foot Drop System	SHENZHEN XFT Medical	Foot drop stimulator	K162718	2017	GZI
MyGait® Stimulation System	Otto Bock HealthCare	Foot drop stimulator	K141812	2015	GZI
ERGYS (TTI Rehabilitation Gym)	Therapeutic Alliances	Leg cycle ergometer	K841112	1984	IPF
RT300	Restorative Therapies, Inc (RTI)	Cycle ergometer	K050036	2005	GZI
Myocycle Home	Myolyn	Cycle ergometer	K170132	2017	GZI
StimMaster Orion	Electrologic (no longer in business)

FDA: U.S. Food and Drug Administration.

To date, the Parastep® Ambulation System (Sigmedics) is the only noninvasive functional walking neuromuscular stimulation device to receive premarket approval from the FDA. The Parastep device is approved to “enable appropriately selected skeletally mature spinal cord injured patients (level C6-T12) to stand and attain limited ambulation and/or take steps, with assistance if required, following a prescribed period of physical therapy training in conjunction with rehabilitation management of spinal cord injury.”^1, FDA product code: MKD.

Related Policies

• Powered Exoskeleton for Ambulation in Patients with Lower Limb Disabilities (Policy #043 in the DME Section)
• Myoelectric Prosthetic and Orthotic Components for the Upper Limb (Policy #034 in the DME Section)
• Microprocessor-Controlled Prostheses for the Lower Limb (Policy #031 in the DME Section)

A. A neuromuscular electrical stimulation (NMES) device must be ordered by the treating physician.

B. A NMES device is considered medically necessary in the treatment of disuse atrophy (when nerve supply is intact, including brain, spinal cord and peripheral nerves) resulting from, but not limited to, the following conditions:
1. cerebrovascular accident;
2. prolonged immobilization of a limb (i.e., casting, splinting);
3. contracture due to scarring of soft tissue in burns;
4. hip replacement surgery (until orthotic training begins);
5. knee surgery.

C. When an NMES device is considered medically necessary and appropriate, generally, a three month rental should be reasonable. Additional documentation substantiating response to the treatment should be submitted in the event that the NMES device is required beyond this period.

D. When extended or long-term (longer than 3 months) use of NMES device is considered medically necessary as determined on a case by case basis by the medical director, the device may either be purchased or rented whichever charge is less. Under no circumstances should the total payment exceed the allowed purchase price of the device.

E. A NMES device is considered not medically necessary when it is used to reduce postsurgical swelling or lymphedema.

F. The use of a device that incorporates muscular stimulation and interferential current stimulation modalities into one unit (e.g., RS-4i, RS-4m, RS-2s sequential stimulators) in the treatment of disuse atrophy or any other condition is considered investigational because its effectiveness has not yet been established in the peer-reviewed medical literature.

A. provide or promote ambulation in members with spinal cord injury (e.g., Parastep Ambulation System).

B. improve ambulation in members with gait disorders such as foot drop caused by nerve damage such as in post-stroke members or in those with multiple sclerosis, and by congenital disorders such as cerebral palsy (e.g., WalkAide, NESS L300, ODFS Dropped Foot Stimulator) .

C. provide upper extremity function in members with nerve damage such as spinal cord injury or post-stroke.

· Persons with intact lower motor units (L1 and below) (both muscle and peripheral nerve);
· Persons with muscle and joint stability for weight bearing at upper and lower extremities that can demonstrate balance and control to maintain an upright support posture independently;
· Persons that demonstrate brisk muscle contraction to NMES and have sensory perception electrical stimulation sufficient for muscle contraction;
· Persons that possess high motivation, commitment and cognitive ability to use such devices for walking;
· Persons that can transfer independently and can demonstrate independent standing tolerance for at least 3 minutes;
· Persons that can demonstrate hand and finger function to manipulate controls;
· Persons with at least 6-month post recovery spinal cord injury and restorative surgery;
· Persons without hip and knee degenerative disease and no history of long bone fracture secondary to osteoporosis; and
· Persons who have demonstrated a willingness to use the device long-term.

· Persons with cardiac pacemakers;
· Severe scoliosis or severe osteoporosis;
· Skin disease or cancer at area of stimulation;
· Irreversible contracture; or
· Autonomic dysflexia.

For members enrolled in Medicaid and NJ FamilyCare plans, Horizon BCBSNJ applies the above medical policy.

FIDE SNP: For members enrolled in a Fully Integrated Dual Eligible Special Needs Plan (FIDE-SNP): (1) to the extent the service is covered under the Medicare portion of the member’s benefit package, the above Medicare Coverage statement applies; and (2) to the extent the service is not covered under the Medicare portion of the member’s benefit package, the above Medicaid Coverage statement applies.

[RATIONALE: This policy was created in 1994 and has been updated regularly using searches of the PubMed database. The most recent literature update was performed through March 9, 2020.

Evidence reviews assess the clinical evidence to determine whether the use of technology improves the net health outcome. Broadly defined, health outcomes are the length of life, quality of life, and ability to function including benefits and harms. Every clinical condition has specific outcomes that are important to patients and managing the course of that condition. Validated outcome measures are necessary to ascertain whether a condition improves or worsens; and whether the magnitude of that change is clinically significant. The net health outcome is a balance of benefits and harms.

To assess whether the evidence is sufficient to draw conclusions about the net health outcome of technology, 2 domains are examined: the relevance, and quality and credibility. To be relevant, studies must represent 1 or more intended clinical use of the technology in the intended population and compare an effective and appropriate alternative at a comparable intensity. For some conditions, the alternative will be supportive care or surveillance. The quality and credibility of the evidence depend on study design and conduct, minimizing bias and confounding that can generate incorrect findings. The randomized controlled trial (RCT) is preferred to assess efficacy; however, in some circumstances, nonrandomized studies may be adequate. RCTs are rarely large enough or long enough to capture less common adverse events and long-term effects. Other types of studies can be used for these purposes and to assess generalizability to broader clinical populations and settings of clinical practice. The following is a summary of the key literature to date.

Upper-Extremity Function After Spinal Cord Injury and Stroke
Clinical Context and Therapy Purpose
One application of functional electrical stimulation (FES) is to restore upper-extremity functions such as grasp-release, forearm pronation, and elbow extension in patients with stroke, or C5 and C6 tetraplegia (quadriplegia).
The question addressed in this policy is: Does FES for the upper extremity improve health outcomes in patients with spinal cord injury (SCI), stroke, or chronic upper-extremity paresis?
The following PICO was used to select literature to inform this policy.

Patients
The relevant population of interest is patients with SCI or stroke with chronic upper-extremity paresis.

Interventions
The therapy being considered is FES. NeuroControl Corp. developed the Freehand System, an implantable upper-extremity neuroprosthesis, to improve the ability to grasp, hold, and release objects for patients with tetraplegia due to C5 or C6 SCI. NeuroControl is no longer in business, but FES centers in the United States and United Kingdom provide maintenance for implanted devices.
The NESS H200 (previously known as the Handmaster NMS I system) is an upper-extremity device that uses a forearm splint and surface electrodes. The device, controlled by a user-activated button, is intended to provide hand function (fine finger grasping, larger palmar grasping) for patients with C5 tetraplegia or stroke.

Other hand stimulators that have been cleared for marketing in the United States are:

• ReGrasp by Rehabtronics
• MyndMove by MyndTec. This device is currently being studied in a clinical trial for rehabilitation.

Comparators
The following practices are currently being used to make decisions about FES for upper-extremity paresis: function without FES.
Patients with SCI or stroke with chronic upper-extremity paresis are actively managed by neurologists and physical therapists.

Outcomes
The general outcomes of interest include the ability to grasp, hold, and lift objects, along with other selected activities of daily living (ADL).
Available literature indicates training and follow-up for 3 weeks to 2 months.

Study Selection Criteria

Methodologically credible studies were selected using the following principles:

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs.
• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.
• To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.
• Studies with duplicative or overlapping populations were excluded.

Much of the early published evidence assessing upper-extremity devices to restore function in patients with SCIs reported on experience with the Freehand System, an implantable device no longer marketed in the United States.^2,3,4,5,

Handmaster

Studies with the first version of the NESS H200 (Handmaster), were reported in patients with upper-extremity paresis following stroke and SCI (see Tables 2 and 3).

Alon et al (2003) evaluated the Handmaster device in 7 subjects with C5 or C6 SCI who practiced using the device daily in an effort to regain the ability to grasp, hold, and release objects.^6, All patients were observed 2 to 3 times during the week for 3 weeks, and they were evaluated on their ability to perform the following tasks: pick up a telephone, eat food with a fork, perform an individually selected ADL task, and perform 2 tasks relating to grasping, holding, and releasing certain items. At the end of the study, all 7 subjects successfully used the device for each required task. Improvements occurred in secondary measures of grip strength, finger linear motion, and Fugl-Meyer Assessment scores (the instrument assesses sensorimotor recovery after stroke).

Alon et al (2002), reporting on a case series of 29 patients, investigated whether the Handmaster system could improve select hand function in persons with chronic upper-extremity paresis following stroke.^7,The main outcome measures were 3 ADL tasks: lifting a 2-handled pot, holding a bag while standing with a cane, and another ADL chosen by the patient. At the end of the 3-week study period, the percentage of successful trials compared with baseline were lifting pot, 93% versus 0%; lifting 600-gram weight, 100% versus 14%; and lifting bag, 93% versus 17%. All subjects performed their selected ADLs successfully and improved their Fugl-Meyer Assessment scores using the neuroprosthesis.

Snoek et al (2000) reported on use of the Handmaster NMS I, another upper-extremity device, for a series of 10 patients with cervical SCIs.^8, After 2 months of training, performance on a defined set of tasks, and 1 or more tasks chosen by the patient was evaluated. In 6 patients, a stimulated grasp and release with either 1 or both grasp modes (key and palmar pinch) of the Handmaster was possible. Four patients could perform the set of tasks with but not without the Handmaster.

Table 2. Key Case Series Characteristics

Study	Participants	Treatment	Follow-Up
Alon et al (2003)6,	7 patients with C5 or C6 SCI	Handmaster NMS	3 weeks of training
Alon et al (2002)7,	29 patients with chronic upper-extremity paresis following stroke	Handmaster NMS	3 weeks of training
Snoek et al (2000)8,	10 patients with cervical SCI	Handmaster NMS I	2 months of training

SCI: spinal cord injury

Table 3. Key Case Series Results

Study	Timing	Task 1	Task 2	Task 3
Alon et al (2003)6,		Pick up a telephone	Eat with a fork	Individually selected ADL
	Post-training	100%	100%	100%
Alon et al (2002)7,		Lifting Pot	Lifting 600-gram weight	Lifting bag
	Baseline	0%	14%	17%
	Post-training	93%	100%	93%
Snoek et al (2000)8,		Grasp and Release
	Baseline	20%	NA	NA
	Post-training	60%	NA	NA

ADL: activities of daily living; NA: not applicable.

Section Summary: Upper-Extremity Function After Spinal Cord Injury and Stroke

The evidence on FES for the upper limbs in patients with SCI or stroke includes a limited number of small case series. Interpretation of the evidence for upper-extremity neuroprostheses for these populations is limited by the small number of patients studied and lack of data demonstrating its utility outside the investigational (study) setting.

Functional Electrical Stimulation for Chronic Foot Drop
Clinical Context and Therapy Purpose
Other FES devices have been developed to provide FES for patients with foot drop. Foot drop is weakness of the foot and ankle that causes reduced dorsiflexion and difficulty with ambulation. It can have various causes such as cerebral palsy, stroke, or multiple sclerosis (MS). FES of the peroneal nerve has been suggested for these patients as an aid in raising the toes during the swing phase of ambulation.
The question addressed in this policy is: Does FES improve the net health outcome in patients with foot drop?
The following PICO was used to select literature to inform this policy.

Patients
The relevant population of interest is patients with foot drop due to stroke, MS, or cerebral palsy.

Interventions
The therapy being considered is FES.
With these devices, a pressure sensor detects heel-off and initial contact during walking. A signal is then sent to the stimulation cuff, initiating or pausing the stimulation of the peroneal nerve, which activates the foot dorsiflexors. Examples of such devices used for treatment of foot drop are:

• WalkAide by Innovative Neurotronics (formerly NeuroMotion),
• L300 Go by Bioness
• MyGait by Otto Bock
• OFDS (Odstock Foot Drop Stimulator) and ODFS Pace XL by Odstock.

Comparators
The following therapies are currently being used to make decisions about foot drop: foot/ankle orthoses.
Patients with foot drop are actively managed by neurologists and physical therapists.

Outcomes
Ability to walk is the primary outcome of interest. There are established measures of walking, mobility and quality of life. These include:

• 10-meter walk test (10MWT): Assesses the time it takes to walk 10 meters
• 6-minute walk test (6MWT): assesses the distance walked in 6 minutes
• Timed up-and-go: assesses the time required to get up from a chair and take a step
• Stroke Impact Scale

Study Selection Criteria

Methodologically credible studies were selected using the following principles:

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs.
• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.
• To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.
• Studies with duplicative or overlapping populations were excluded.

Two multicenter RCTs were identified on FES for dropped foot (see Tables 4 and 5).

FES with a dropped foot stimulator (WalkAide) was compared with an ankle-foot orthosis (AFO) in a 2014 industry-sponsored multicenter non-inferiority trial (NCT01087957) that included 495 Medicare-eligible individuals who were at least 6 months poststroke.^9, A total of 399 individuals completed the 6-month study. Primary outcome measures were the 10MWT, a composite measure of daily function, and device-related serious adverse events. Seven secondary outcome measures assessed function and quality of life. The intention-to-treat analysis found that both groups improved walking performance over the 6 months, and the FES device was found noninferior to the AFO for the primary outcome measures. Only the WalkAide group showed significant improvements from baseline to 6 months on several secondary outcome measures, but there were no statistically significant between-group differences for any outcome.

The Functional Ambulation: Standard Treatment vs. Electronic Stimulation Therapy (FASTEST) Trial in Chronic Post-Stroke Subjects With Foot Drop ( NCT01138995) was a 2013 industry-sponsored, single-blinded, multicenter trial that randomized 197 stroke patients to 30 weeks of a dropped foot stimulator (NESS L300) or a conventional AFO.^10, The AFO group received transcutaneous electrical nerve stimulation at each physical therapy visit during the first 2 weeks to provide a sensory control for stimulation of the peroneal nerve received by the NESS L300 group. Evaluation by physical therapists blinded to group assignment found that both groups improved gait speed and other secondary outcome measures over time, with a similar improvement in the 2 groups. There were no between-group differences in the number of steps per day at home, which was measured by an activity monitor over a week. User satisfaction was higher with the foot drop stimulator.

O-Dell et al (2014) reported on a secondary analysis of data from the FASTEST study.^11, Comfortable gait speed was assessed in the 99 individuals from the NESS L300 group at 6, 12, 30, 36, and 42 weeks, with and without the use of the foot drop stimulator. A responder was defined as one achieving a minimal clinically important difference of 0.1 m/s on the 10MWT or advancing by at least 1 Perry Ambulation Category (which measures functional walking ability in the home or community). Noncompleters were classified as nonresponders. Seventy percent of participants completed the assessments at 42 weeks, and 67% of participants were classified as responders. Of the 32 participants classified as nonresponders, 2 were nonresponders, and 30 were noncompleters. The percentage of patients in the conventional AFO group classified as responders at 30 weeks was not reported. There were 160 adverse events, of which 92% were classified as mild. Fifty percent of the adverse events were related to reversible skin issues, and 27% were falls.

Table 4. Key RCT Characteristics

Trial	Countries	Sites	Dates	Participants	Interventions
					Active	Comparator
Bethoux et al (2014)9,	US	29	2010- 2013	495 Medicare-eligible individuals who were at least 6 months poststroke	6 months with WalkAide	6 months with conventional AFO
Kluding et al (2013)10, FASTEST	US	11	2010- 2013	197 stroke patients	30 weeks of NESS L300	30 weeks with conventional AFO

AFO: ankle-foot orthosis; FASTEST: Functional Ambulation: Standard Treatment vs. Electronic Stimulation Therapy Trial in Chronic Post-Stroke Subjects With Foot Drop; RCT: randomized controlled trial.

Table 5. Key RCT Results

Study	Improvement in 10MWT (m/s)	Daily Function	Improvement in 6MWT (m)	Functional Mobility	Device safety
Bethoux et al (2014)9,	n=399	Improvement in a composite outcome measure on the SIS		Improvement in TUG (s)	Serious adverse events
WalkAide	0.186	5.0	33.1	2.2	0
AFO	0.195	3.9	18.0	1.5	2
P-value non-inferiority	<.001	<.001	.17		<.001
Kluding et al (2013)10, FASTEST		Change in SIS mobility score
L300	0.14±0.16	7.06±13.79	40.9 ± 62.1	−5.93 (13.06)
AFO	0.15±0.14	5.83±13.26	48.6 ± 51.1	−4.38 (21.37)
P-value	.75	.52	.34	.54

6MWT: 6-minute walk test; 10MWT; 10-meter walk test; AFO: Ankle-foot orthosis; FASTEST: Functional Ambulation: Standard Treatment vs. Electronic Stimulation Therapy Trial in Chronic Post-Stroke Subjects With Foot Drop; RCT: randomized controlled trial; SIS: stroke impact scale; TUG: timed up-an-go.

Limitations in study design and conduct are shown in Table 6. The primary limitation for both studies was unequal loss to follow-up, with higher loss to follow-up in the FES group. Inability to tolerate the electrical stimulation has been noted in some studies.

Table 6. Study Design and Conduct Limitations

Study	Allocationa	Blindingb	Selective Reportingc	Data Completenessd	Powere	Statisticalf
Bethoux et al (2014)9,				1. 19% loss to follow-up with a higher loss to follow-up in the Walk-Aide discontinuing the study
Kluding et al (2013)10,				1. 18% loss to follow-up with a higher loss to follow-up in the L300 group

The study limitations stated in this table are those notable in the current review; this is not a comprehensive limitations assessment.

^a Allocation key: 1. Participants not randomly allocated; 2. Allocation not concealed; 3. Allocation concealment unclear; 4. Inadequate control for selection bias.
^b Blinding key: 1. Not blinded to treatment assignment; 2. Not blinded outcome assessment; 3. Outcome assessed by treating physician.
^c Selective Reporting key: 1. Not registered; 2. Evidence of selective reporting; 3. Evidence of selective publication.
^d Data Completeness key: 1. High loss to follow-up or missing data; 2. Inadequate handling of missing data; 3. High number of crossovers; 4. Inadequate handling of crossovers; 5. Inappropriate exclusions; 6. Not intent to treat analysis (per protocol for noninferiority trials).
^e Power key: 1. Power calculations not reported; 2. Power not calculated for primary outcome; 3. Power not based on clinically important difference.
^f Statistical key: 1. Analysis is not appropriate for outcome type: (a) continuous; (b) binary; (c) time to event; 2. Analysis is not appropriate for multiple observations per patient; 3. Confidence intervals and/or p values not reported; 4. Comparative treatment effects not calculated.

Berenpas et al (2019) compared the effectiveness of implanted FES versus AFO in helping stroke patients with foot drop avoid obstacles while walking (“gait adaptability”).^12,Two cohorts were studied: the first (n = 10) were followed for 26 weeks; the second (n = 12) were followed for 52 weeks. All study participants had experienced stroke more than 6 months prior and regularly used an AFO. A within-subjects repeated measures design was used. Gait adaptability was tested by having participants walk on a treadmill while obstacles were suddenly dropped in front of the paretic leg. Before implantation of the device, participants were tested using only the AFO (at 2 or 3 km/h). Patients were then implanted with a 4-channel peroneal nerve stimulator (ActiGait). Testing was then conducted with FES and with AFO at 2 weeks postimplantation, then at 8 weeks, 26 weeks, and, for the second cohort, 52 weeks. Available response time (ART) was calculated “as the time between obstacle release and the moment the toe would have crossed the front edge of the obstacle in the case of an unaltered step.” ART was stratified into 3 categories based on at what point in the gait cycle the obstacle was dropped: 450-600 ms (mid stance), 300-450 ms (late stance/early swing), and 150-300 ms (mid swing). Results showed FES success rates were an average of 4.7% higher than with AFO (55.4% vs. 50.7%; P =.03). Significant differences were seen between the 3 ARTs (P <.001), with higher success rates with longer ARTs. The individual results ranged widely in differences between devices—at 26 weeks they ranged from –29% to 85%. The small sample size and absence of control group limit the study’s generalizability, but larger controlled studies would be difficult given the requirements of the intervention.

Multiple Sclerosis
Randomized Controlled Trials

Renfrew et al (2019) compared clinical effectiveness of FES versus AFO in their multicenter randomized trial.^13,The study took place over 12 months and included 85 treatment-naive patients with MS who had had foot drop for more than 3 months. The patients were randomized to receive either an Odstock Dropped Foot Stimulator (n = 42) or AFO (n = 43). By 12 months, 32 patients (38%) had dropped out of the study. Outcome measurements were taken at baseline, 3, 6, and 12 months (except the Psychological Impact Score, which was measured only at 12 months). The primary outcome measure was the 5-minute self-selected walk test in which participants walked at their preferred pace around a 9.5-m elliptical course for 5 minutes and total distance was recorded. Other outcomes included the Timed 25 Foot Walk Test, Multiple Sclerosis Impact Scale-29 (higher scores indicate a greater impact on life), and the Activities-specific Balance and Confidence Scale (higher score indicates more confidence). Results are shown in Table 8. Also measured were orthotic effects and oxygen cost of walking. Clinically significant orthotic and therapeutic effects were deemed an observed increase in walking speed of ≥ 0.05 m/s. The FES group saw a clinically significant ongoing orthotic effect for both walk tests at 3, 6, and 12 months, but the AFO group did not. For total orthotic effect at 12 months, the AFO results for the 5-minute self-selected walk test were clinically significant, but the FES were not. Although both devices improved walking speed at 12 months, the differences in their effects were not significant.

Two publications from 1 RCT were identified on use of a dropped foot stimulator in patients with MS (see Tables 7 and 8). Barrett et al (2009) assessed FES to improve walking performance in patients with MS.^14, Fifty-three patients with secondary progressive MS and unilateral dropped foot were randomized to an 18-week program of an Odstock Dropped Foot Stimulator device or a home exercise program. Patients in the stimulator group were encouraged to wear the device most of the day, switching it on initially for short walks and increasing daily for 2 weeks, after which they could use the device without restriction. Subjects in the control group were taught a series of exercises tailored to the individual to be done twice daily. Six patients in the FES group and 3 in the exercise group dropped out, leaving 20 in the FES group and 24 in the exercise group. The primary outcome measure was the 10MWT. At 18 weeks, the exercise group walked significantly faster than the FES group (P =.028).

A 2010 publication by the same investigators reported on the impact of the treatment on ADL.^15, Results of 53 patients from the trial previously described were reported, using the Canadian Occupational Performance Measure. The Canadian Occupational Performance Measure is a validated semi-structured interview (higher scores indicate improvement) originally designed to assist occupational therapy interventions. The interviews at baseline identified 265 problems of which 260 activities were related to walking and mobility. Subjective evaluation at 18 weeks showed greater improvements in performance and satisfaction scores in the FES group (35% of the identified problems increased by a score of ³2) than in the exercise group (17% of problems increased by a score of ³2). The median satisfaction rating improved from 2.2 to 4.0 in the FES group and remained stable (2.6 to 2.4) in the exercise group. The median number of falls recorded per patient over the 18-week study was 5 in the FES group and 18 in the exercise group. About 70% of the falls occurred while not using the FES device or an AFO.

Table 7. Summary of Key RCT Characteristics

Study	Countries	Sites	Participants	Interventions
				Active	Comparator
Renfrew et al (2019)13,	Scotland	7	85 treatment-naive patients with MS and >3 of foot drop	12 months of FES; measured at baseline, 3, 6, 12 mo.; gradually increased device wear over first 6 wk	Ankle-foot orthosis
Barrett et al (2009)14,Esnouf et al (2010)15,	EU	1	53 patients with unilateral dropped foot	18 weeks of FES	Twice daily exercises that were tailored to the patient

FES: functional electrical stimulation; RCT: randomized controlled trial.

Table 8. Summary of Key RCT Results

Study	Walking Pace, m/s	Daily Function	Walking Distance, m	Functional Mobility	Device Safety
Renfrew et al (2019)13,(N=85)	25 ft WT, mean (SD)a 5 minSSWT, mean (SD)a	MSIS-29 (physical), mean, SD	NR	ABC, mean (SD)	NR
FES	0.95 (0.30) 0.73 (0.26)	34.2 (17.4)	NR	53.7 (20.3)	NR
AFO	0.71 (0.24) 0.96 (0.31)	33.8 (15.2)	NR	52.2 (23.5)	NR
P-value	.043 .0005	.836	NR	.378	NR
Barrett et al (2009)14, Esnouf et al (2010)15, (N=44)	10MWT, mean (SD)	Physiologic Cost Index	3MWT, mean (SD)	Canadian Occupational Performance Measure	Falls
FES	0.74 (0.026)	0.69 (0.041)	124 (8.5)	35%	5
Exercise	0.82 (0.024)	0.70 (0.037)	112 (7.9)	17%	18
P-value	.028	.81	.334	<.05	.036

25ftWT: 25-foot walk test; 3MWT: 3-minute walk test; 6MWT: 5minSSWT: 5-minute self-selected walk test; 6-minute walk test; 10MWT; 10-meter walk test; ABC: activities and balance confidence scale; AFO: ankle-foot orthosis; FES: functional electrical stimulation; mo: month(s); MSIS-29 (physical) Multiple Sclerosis Impact Scale physical subscale; m/s: meters per second; SD: standard deviation; RCT: randomized controlled trial;.

^a At 12 months without use of FES/AFO.

Table 9. Study Relevance Limitations

Study	Populationa	Interventionb	Comparatorc	Outcomesd	Follow-Upe
Renfrew et al (2019)13,
Barrett et al (2009)14, Esnouf et al (2010) 15,		4. Patients were highly selected

The study limitations stated in this table are those notable in the current review; this is not a comprehensive limitations assessment.

^a Population key: 1. Intended use population unclear; 2. Clinical context is unclear; 3. Study population is unclear; 4. Study population not representative of intended use.
^b Intervention key: 1. Not clearly defined; 2. Version used unclear; 3. Delivery not similar intensity as comparator; 4. Not the intervention of interest.
^c Comparator key: 1. Not clearly defined; 2. Not standard or optimal; 3. Delivery not similar intensity as intervention; 4. Not delivered effectively.
^d Outcomes key: 1. Key health outcomes not addressed; 2. Physiologic measures, not validated surrogates; 3. No CONSORT reporting of harms; 4. Not establish and validated measurements; 5. Clinical significant difference not prespecified; 6. Clinical significant difference not supported.
^e Follow-Up key: 1. Not sufficient duration for benefit; 2. Not sufficient duration for harms.

Study	Allocationa	Blindingb	Selective Reportingc	Data Completenessd	Powere	Statisticalf
Renfrew et al (2019)13,		1, 2,3. No blinding employed				3 Confidence intervals not reported
Barrett et al (2009)14, Esnouf et al (2010)15,		2., 3 Blinding was assessed by the treating physician		6. Not intention-to-treat analysis	2. Loss to follow-up resulted in insufficient power

^a Allocation key: 1. Participants not randomly allocated; 2. Allocation not concealed; 3. Allocation concealment unclear; 4. Inadequate control for selection bias.
^b Blinding key: 1. Not blinded to treatment assignment; 2. Not blinded outcome assessment; 3. Outcome assessed by treating physician.
^c Selective Reporting key: 1. Not registered; 2. Evidence of selective reporting; 3. Evidence of selective publication.
^d Data Completeness key: 1. High loss to follow-up or missing data; 2. Inadequate handling of missing data; 3. High number of crossovers; 4. Inadequate handling of crossovers; 5. Inappropriate exclusions; 6. Not intent to treat analysis (per protocol for noninferiority trials).
^e Power key: 1. Power calculations not reported; 2. Power not calculated for primary outcome; 3. Power not based on clinically important difference.
^f Statistical key: 1. Analysis is not appropriate for outcome type: (a) continuous; (b) binary; (c) time to event; 2. Analysis is not appropriate for multiple observations per patient; 3. Confidence intervals and/or p values not reported; 4. Comparative treatment effects not calculated.

A systematic review was identified on use of a dropped foot stimulator for children with cerebral palsy (see Table 11).

Cauraugh et al (2010) conducted a systematic review and meta-analysis of 17 studies on FES and gait in children with cerebral palsy (see Table11).^16, Fourteen studies used a pretest-posttest that included a within-subjects design. A total of 238 participants had FES. Included were studies on acute FES, FES, and therapeutic FES (continuous subthreshold stimulation). Five studies examined FES, 1 of which examined percutaneous FES. Impairment was assessed by 3 outcome measures: range of motion, torque/movement, and strength/force. Activity limitations were assessed by 6 outcome measures: gross motor functions, gait parameters, hopping on 1 foot, 6MWT, Leg Ability Index, and Gillette Gait Index. Moderate effect sizes were found for impairment (0.616) and activity limitations (0.635). Studies selected for the review lacked blinding and were heterogeneous for outcome measures. Reviewers did not report whether any study used a commercially available device.

Section Summary: Functional Electrical Stimulation for Chronic Foot drop

For chronic poststroke foot drop, 2 RCTs comparing FES with a standard AFO showed improved patient satisfaction with FES but no significant differences between groups in objective measures such as walking. A longitudinal cohort study assessed patients’ ability to avoid obstacles while walking on a treadmill using FES versus AFO. Although the FES group averaged a 4.7% higher rate of avoidance, the individual results between devices ranged widely. One RCT with 53 subjects examining neuromuscular stimulation for foot drop in patients with MS showed a reduction in falls and improved patient satisfaction compared with an exercise program but did not demonstrate a clinically significant benefit in walking speed. Another other RCT showed that at 12 months, both FES and AFO had improved walking speed, but the difference in improvement between the 2 devices was not significant. A reduction in falls is an important health outcome. However, it was not a primary study outcome and should be confirmed in a larger number of patients. The literature on FES in children with cerebral palsy includes a systematic review of small studies with within-subject designs. Further study in a larger number of subjects is needed to permit conclusions on the effect of the technology on health outcomes.

Ambulation in Patients With Spinal Cord Injury
Clinical Context and Therapy Purpose

Another application of FES is to provide patients with SCI the ability to stand and walk. Using percutaneous stimulation, the device delivers trains of electrical pulses to trigger action potentials at selected nerves at the quadriceps (for knee extension), the common peroneal nerve (for hip flexion), and the paraspinals and gluteals (for trunk stability). Patients use a walker or elbow-support crutches for further support. The electric impulses are controlled by a computer microchip attached to the patient’s belt, which synchronizes and distributes the signals. In addition, there is a finger-controlled switch that permits patient activation of the stepping.

Other devices include a reciprocating gait orthosis with electrical stimulation. The orthosis used is a cumbersome hip-knee-ankle-foot device linked together with a cable at the hip joint. The use of this device may be limited by the difficulties in donning and doffing the device.
The purpose of FES for ambulation in patients who have SCI is to provide a treatment option that is an alternative to or an improvement on existing therapies.
The question addressed in this policy is: Does FES improve the net health outcome in patients with SCI?
The following PICO was used to select literature to inform this policy.

Patients
The relevant population of interest is patients with SCI.
Generally, only SCI patients with lesions from T4 to T12 are considered candidates for ambulation systems. Lesions at T1 to T3 are associated with poor trunk stability, while lumbar lesions imply lower-extremity nerve damage.

Interventions
The therapy being considered is FES for ambulation.

To date, the Parastep® Ambulation System (Sigmedics) is the only noninvasive functional walking neuromuscular stimulation device to receive premarket approval from the U.S. Food and Drug Administration (FDA). The Parastep device is approved to “enable appropriately selected skeletally mature spinal cord injured patients (level C6 to T12) to stand and attain limited ambulation and/or take steps, with assistance if required, following a prescribed period of physical therapy training in conjunction with rehabilitation management of spinal cord injury.”^1,

Patients with SCI are actively managed by neurologists and physical therapists.

Comparators
The following therapies are currently being used to make decisions about FES for ambulation: no walking.
Patients with SCI are actively managed by neurologists and physical therapists.

Outcomes

The clinical impact of the Parastep device rests on the identification of clinically important outcomes. The primary purpose of this device is to provide a degree of ambulation that improves patient ability to complete the ADLs or positively affect the patient’s quality of life. Physiologic outcomes (ie, conditioning, oxygen uptake) have also been reported, but they are intermediate, short-term outcomes.

Based on available literature, longer-term outcomes would require follow-up of at least 18 months.

Study Selection Criteria

Methodologically credible studies were selected using the following principles:

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs.
• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.
• To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.
• Studies with duplicative or overlapping populations were excluded.

Brissot et al (2000) found that 13 of 15 patients evaluated in a case series achieved independent ambulation.^24, Five of the 13 patients continued using the device for physical fitness at home, but none used it for ambulation. Sykes et al (1996) found low use of a reciprocating gait orthosis device with or without stimulation over an 18-month period,^25, and Davis et al (2001) found mixed usability/preference scale results for ambulation, standing, and transfers with a surgically implanted neuroprosthesis in 12 patients followed for 12 months.^26, The effects of a surgically implanted neuroprosthesis on exercise, standing, transfers, and quality of life were also reported in 2012.^27,28,, The device used in both studies was not commercially available at that time.

Several publications reported on physiologic responses to use of the Parastep device. Jacobs et al (1997) found a 25% increase in time to fatigue and a 15% increase in peak oxygen uptake, consistent with an exercise training effect.^19, Needham-Shropshire et al (1997) reported no relation between use of the Parastep device and bone mineral density, although the interval between measurements (12 weeks) and the precision of the testing device might have limited the ability to detect a difference.^20, Nash et al (1997) reported that use of the Parastep device was associated with an increase in arterial inflow volume to the common femoral artery, perhaps related to the overall conditioning response to the Parastep.^22,

Table 11. Key Case Series

Study	Participants	Ambulation n (%)	Distance walked	Physical Fitness	Limitations
Chaplin et al (1996)17,	91 adults with SCI	31 (34%) could ambulate without assistance			84 (92%) could take some steps
Guest et al (1997)21,	16 adults with SCI		334 meters	Improvements in the leg
Brissot et al (2000)24,	15 adults with SCI	13 (87%) patients achieved independent ambulation		5 used the device for physical fitness	No patient used the device for ambulation at home

SCI: spinal cord injury.

Section Summary: Ambulation in Patients With Spinal Cord Injury

The evidence on functional FES for standing and walking in patients with SCI consists of case series. Case series are considered adequate for this condition because there is no chance for ambulation in patients with SCI between segments T4 to T12. As stated by various authors, these systems are not designed as alternatives to a wheelchair and offer, at best, limited, short-term ambulation. Some studies have reported improvements in intermediate outcomes, but improvement in health outcomes (eg, ability to perform ADLs) have not been demonstrated. Finally, evaluations of these devices were performed immediately after initial training or during limited study period durations. There are no data in which patients remained compliant and committed with long-term use.

Functional Electrical Stimulation Exercise Equipment for Spinal Cord Injuries
Clinical Context and Therapy Purpose

The U.S. Department of Health and Human Services Office of Disease Prevention and Health Promotion recommends 2 days per week of muscle strengthening for both healthy adults and adults with disabilities, and at least 150 minutes to 300 minutes (5 hours) of moderate-intensity aerobic activity per week or 75 minutes to 150 minutes of vigorous aerobic activity.^29, In patients with SCI, inactivity due to injury or barriers to exercise can lead to multiple degenerative changes that include muscle atrophy, bone mass loss and osteoporosis, and reduction in cardiopulmonary function. Other adverse effects of inactivity that are common with SCI include muscle spasms and weight gain, which may predispose individuals to metabolic syndrome, type 2 diabetes, and their associated health problems.

FES cycle ergometers are available in rehabilitation facilities. An ergometer is a device that measures work performed by exercising. When the term "ergometer" is used in the context of FES, it refers to exercise equipment that measures both position and speed and stimulates muscles in a prescribed sequence to provide coordinated movement (eg, cycling) of the paralyzed limb. The devices can provide increasing resistance as work capacity increases, and reduce stimulation when fatigue is detected (eg, a speed of cycling below 35 rpm). Some models of FES cycle ergometers have been designed for home exercise in individuals with SCI and are the focus of this policy.

The proposed benefit of FES exercise equipment is to counteract the health consequences of paralyzed limbs and include:

• Prevention of muscle atrophy
• Reduction of muscle spasms
• Improvement of circulation
• Improvement in range of motion
• Improvement in cardiopulmonary function
• Reduction in pressure sore frequency
• Improvements in bowel and bladder function
• Decreased incidence of urinary tract infections

1. Are there demonstrated health benefits of FES cycle ergometers in patients with SCI?
2. Do the different devices provide similar health benefits?
3. What levels of compliance are needed to obtain a health benefit?

Patients
The relevant population of interest is patients with lower extremity paresis.

Interventions
The therapy being considered is FES for home exercise.
The majority of home FES devices are cycle ergometers for the lower limbs of patients with lower extremity paresis, although some devices may also include upper arm exercise. All of the devices have evolved over the past 3 decades. Some have internet capability and can be programmed remotely.

• The REGYS and ERGYS series ergometers are manufactured by Therapeutic Alliances. These devices are the largest, include a computer console, and require transfer to an integrated seat. The ERGYS3 is afourth generation device; earlier models continue to be utilized.
• There are several models of the RT300 by Restorative Therapies, Inc (RTI). The RT300-S includes both leg and arm cycles. This device is used with the patient's own wheelchair and does not require a transfer.
• The Myocycle Home by Myolyn is designed for home use and is the simplest of the cycle ergometers.
• The StimMaster Orion was manufactured by Electrologic. Electrologic ceased business operations in 2005.

Outcomes
The general outcomes of interest are reduction in muscle atrophy and muscle spasms, reversal of bone mass loss, improvement in circulation and cardiopulmonary function, and quality of life. These should be measured after at least 3 months of exercise in a home environment with self-directed activity, although supervised training protocols may provide useful information regarding the potential health benefits of cycle ergometers.

Study Selection Criteria

Methodologically credible studies were selected using the following principles:

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs.
• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.
• To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.
• Studies with duplicative or overlapping populations were excluded.

Three within-subject comparisons of health benefits of the RT300 are described in Table 12. Ralson et al (2013) reported on the short-term effects (2 weeks) of the cycle ergometer and found no significant benefit on urine output, lower limb swelling, and spasticity compared with standard rehabilitation.^31, Dolbow et al (2013) reported an improvement in quality of life on 2 of 4 domains.^32, However, only 11 of the original 17 participants who remained in the study after the first 8 weeks were included in this report, and this detail was not reported in the second publication.^33,32, It is notable that the incentive to remain in the study in the first 8 weeks was strong because the Veterans Affairs Medical Center purchased the devices for participants who met exercise requirements over the first 8 weeks of device rental. In the third study, Johnston et al (2009) conducted an RCT to evaluate the health benefits of home FES cycling in children with a pediatric RT300.^34, The 3 groups in this study were FES cycling, passive cycling, and electrical stimulation controls. There was no significant difference in health measures across the groups, although the FES group had a greater within-subject improvement in 1 of 4 health measures. Compliance was supervised by parents, who filled out activity logs and had regular contact with study personnel. Because this study was conducted over a decade ago, it is uncertain if newer models of the RT300 would show greater health benefits.

Table 12. Summary of Studies on the RT300

Study	Study Type	Participants	Treatment	Assessment	Training Duration	Outcome	Limitations
Ralston et al (2013)31,	Prospective within-subject comparison	14 individuals with recent SCI	2-week crossover of FES cycling 4 times per week with the RT300 or standard rehab	Urine output, lower limb swelling, spasticity	2 weeks	No benefit compared to standard rehab	Only 2 weeks of FES may not have been sufficient
Dolbow et al (2013)32,	Prospective within-subject comparison	11 male veterans with SCI (73% with tetraplegia)	Home FES that increased in speed, resistance, and duration over 8 weeks	Quality of Life	8 weeks	Improvement in physical and environmental domains but not psychological and social	Selective reporting of the 11 participants who completed the initial study (Dolbow et al 2012 33,)
Johnston et al (2009)34,	RCT with within-subject comparison	30 children with SCI	Home FES cycling group, with passive cycling and electrical stimulation–only controls	Oxygen uptake, rHR, forced vital Capacity, lipid profile	3 times per week for 6 months	There was no significant difference across groups. The FES group showed a greater percent increase in 1 of 4 measures compared with the control groups	Early model of device that may not be representative of current devices

FES: functional electrical stimulation; RCT: randomized controlled trial; rHR: resting heart rate; SCI: spinal cord injury,

Sadowsky et al (2013) evaluated motor and sensory recovery with long-term use of the ERGYS2.^35, Individuals with SCI who were treated with FES had positive outcomes on motor and sensory scores compared with individuals who did not receive FES, but the retrospective study was limited by potential for selection bias. The within-subject comparisons in Table 13 uniformly show an improvement in aerobic capacity and metabolism with training.Griffin et al (2009) showed in their prospective study that cycling for 30 minutes, 2 to 3 times per week, for 10 weeks on the ERGYS2 resulted in improvements in a number of physiological measures of health (lean muscle mass, work capacity, glucose tolerance, insulin levels, inflammatory markers)along with an improvement in motor and sensory function.^36, These positive results are notable for the relatively short training period. A reduction in bone mass and osteoporosis is common in individuals with SCI, but no studies have demonstrated an improvement in bone mineral density. A major limitation in relevance of the studies for the present policy is that they do not appear to have been conducted in the home environment. The REGYS and ERGYS cycle ergometers have a bulky integrated seat and require transfer from a wheelchair, which may be a significant limitation to home use. Sustained motivation to exercise for 2 to 3 times per week outside of the investigational setting is uncertain. (See Table 13 for more study details.)

Table 13. Summary of Studies on the ERGYS2

Study	Study Type	Participants	Treatment	Assessment	Training Duration	Outcome	Limitations
Sadowsky et al (2013)35,	Retrospective matched comparison	25 adults with chronic SCI who received FES cycling and 20 individuals with SCI who did not receive FES	Long-term rehabilitation on the ERGYS2	> 1-point improvement on the combined motor–sensory scores on the ASIA impairment scale	29 months (range, 3 to 168)	FES improved both motor and sensory scores compared with controls	Potential bias in who was referred for FES
Griffin et al (2009)36,	Prospective within-subject comparison	18 adults with SCI	Cycling for 30 min, 2 to 3 times per week on the ERGYS2	ASIA score, body composition, motor and sensory function, and metabolism	10 weeks	Improvement in lean muscle mass, cycling power, work capacity, endurance, glucose tolerance, insulin levels, inflammatory markers, and motor and sensory neurological function	10 week duration of study

ASIA: American Spinal Injury Association (neurological classification of SCI test battery);; DEXA: Dual energy x-ray absorptiometry, FES: functional electrical stimulation; SCI: spinal cord injury

Kressler et al (2014) conducted an analysis of data usage patterns and energy expenditure of 314 individuals over 20 183 home activity sessions with Restorative Therapies FES cycle ergometers (eg, RT300;see Tables 14 and 15).^37, With use categorized into low (< 2 days/week), medium (2 to 5 days/week) and high use (at least 5 days/week), 71% of individuals with SCI were considered low users with an average of 0.9 days and 34 minutes of cycling per week. Sevenof the 314 individuals were high users (2%) and 83 were medium users (27%). Kressler et al (2014) noted that none of the users met the recommended 1000 kcals/wk, with maximal weekly expenditure of 43 kcals.

Table 14. Characteristics of Studies on Home Use of Restorative Therapies Cycle Ergometers

Study	Country	Participants	Treatment Delivery	Follow-Up
Kressler et al (2014)37,	US	314 individuals with SCI who had home network-connected Restorative Therapies FES cycle ergometers	Analysis of data on usage patterns and energy expenditure from 314 individuals across 20 183 activity sessions	NR

NR: not reported; SCI: spinal cord injury

Table 15. Results on Home Use of Restorative Therapies Cycle Ergometers

Study	Treatment	N (%)	Average days/wk (SD)	Average min/wk (SD)
Kressler et al (2014)37,	< 2 days per week	218 (71%)	0.9 (0.4)	34 (21)
	2 to 5 days per week	83 (27%)	3.1 (0.7)	118 (50)
	> 5 days per week	7 (2%)	6.3 (1.0)	672 (621)

SD: standard deviation

Dolbow et al (2012) assessed factors affecting compliance with recommended levels of activity on a home cycle ergometer.^33, Seventeen veterans with SCI were provided a rental RT300 and instructed to cycle continuously for 40 to 60 minutes, 3 times per week. If the participants achieved the recommended level of exercise, the Veterans Affairs Medical Center would purchase the device. Thus, there was a strong incentive to achieve the recommended level of exercise. Participants were monitored for another 8 weeks after purchase to determine if compliance remained high without the incentive, although participation in a study was also known to improve adherence. Adherence rates were 71.7% for the first 8 weeks and 62.9% for the second 8-week period (not statistically different). The odds of adhering to the exercise program in the first 8 weeks were higher in younger participants (odds ratio [OR] = 4.86, P=.02), in participants who were active prior to the study ( OR = 4.59, P =.02) and in participants with non-FES pain ( OR = 2.22, P=.01). Level of injury, time since injury, and history of depression were not significant factors in adherence. Five older participants dropped out of the study before the second 8-week period began. The remaining participants were included in a subsequent report of the effect of the exercise on quality of life over the 8-weeks of the study.^32,

Section Summary: Functional Electrical Stimulation Exercise Equipment for Spinal Cord Injuries

The evidence on FES exercise equipment consists primarily of within-subject, pretreatment to posttreatment comparisons. Evidence was identified on 2 commercially available FES cycle ergometer models for the home, the RT300 series and the REGYS/ERGYS series. There is a limited amount of evidence on the RT300 series. None of the studies showed an improvement in health benefits, and 1 analysis of use for 314 individuals over 20 000 activity sessions with a Restorative Therapies device showed that a majority of users used the device for 34 minutes per week. Two percent of individuals with SCI used the device for an average of 6 days per week, but caloric expenditure remained low. Compliance was shown in 1 study to be affected by the age of participants and level of activity prior to the study. Studies on the REGYS/ERGYS series have more uniformly shown an improvement in physiologic measures of health and in sensory and motor function. A limitation of these studies is that they all appear to have been conducted in supervised research centers. No studies were identified on long-term home use of ERGYS cycle ergometers. The feasibility and long-term health benefits of using this device in the home is uncertain.

Summary of Evidence

For individuals who have loss of hand and upper-extremity function due to SCI or stroke who receive FES, the evidence includes a few small case series. Relevant outcomes are functional outcomes and quality of life. Interpretation of the evidence is limited by the low number of patients studied and lack of data demonstrating the utility of FES outside the investigational setting. It is uncertain whether FES can restore some upper-extremity function or improve the quality of life. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have chronic foot drop who receive FES, the evidence includes randomized controlled trials (RCTs), a systematic review, and a longitudinal cohort study. Relevant outcomes are functional outcomes and quality of life. For chronic poststroke foot drop, 2 RCTs comparing FES with a standard ankle-foot orthosis (AFO) showed improved patient satisfaction with FES but no significant differences between groups in objective measures such as walking. The cohort study assessed patients’ ability to avoid obstacles while walking on a treadmill using FES versus AFO. Although the FES group averaged a 4.7% higher rate of avoidance, the individual results between devices ranged widely. One RCT with 53 subjects examining neuromuscular stimulation for foot drop in patients with multiple sclerosis showed a reduction in falls and improved patient satisfaction compared with an exercise program but did not demonstrate a clinically significant benefit in walking speed. The other RCT showed that at 12 months, both FES and AFO had improved walking speed, but the difference in improvement between the 2 devices was not significant. A reduction in falls is an important health outcome. However, it was not a primary study outcome and should be corroborated. The literature on FES in children with cerebral palsy includes a systematic review of small studies with within-subject designs. Further study is needed. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have SCI at segments T4 to T12 who receive FES, the evidence includes case series. Relevant outcomes are functional outcomes and quality of life. No controlled trials were identified on FES for standing and walking in patients with SCI. However, case series are considered adequate for this condition because there is no chance for unaided ambulation in this population with SCI at this level. Some studies have reported improvements in intermediate outcomes, but improvements in health outcomes (eg, ability to perform activities of daily living, quality of life) have not been demonstrated. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have SCI who receive FES exercise equipment, the evidence includes prospective within-subject comparisons. Relevant outcomes are symptoms, functional outcomes, and quality of life. The evidence on FES exercise equipment consists primarily of within-subject, pretreatment to posttreatment comparisons. Evidence was identified on 2 commercially available FES cycle ergometer models for the home, the RT300 series and the REGYS/ERGYS series. There islimited evidence on the RT300 series. None of the studies showed an improvement in health benefits, and 1 analysis of use for 314 individuals over 20 000 activity sessions with a Restorative Therapies device showed that a majority of users used the device for 34 minutes per week. Two percent of individuals with SCI used the device for an average of 6 days per week, but caloric expenditure remained low. Compliance was shown in 1 study to be affected by the age of participants and level of activity prior to the study. Studies on the REGYS/ERGYS series have more uniformly shown an improvement in physiologic measures of health and in sensory and motor function. A limitation of these studies is that they all appear to have been conducted in supervised in research centers. No studies were identified on long-term home use of ERGYS cycle ergometers. The feasibility and long-term health benefits of using this device in the home is uncertain. The evidence is insufficient to determine the effects of the technology on health outcomes.

SUPPLEMENTAL INFORMATION
Practice Guidelines and Position Statements

In 2009, the National Institute for Health and Care Excellence (NICE) published guidance stating that the evidence on functional electrical stimulation for footdrop of neurologic origin appeared adequate to support its use.^38, The Institute noted that patient selection should involve a multidisciplinary team. The Institute advised that further publication on the efficacy of functional electrical stimulation would be useful, specifically including patient-reported outcomes (eg, quality of life, activities of daily living) and these outcomes should be examined in different ethnic and socioeconomic groups.

U.S. Preventive Services Task Force Recommendations

Not applicable.

Ongoing and Unpublished Clinical Trials

Some currently unpublished trials that might influence this policy are listed in Table 16.

Table 16. Summary of Key Trials

NCT No.	Trial Name	Planned Enrollment	Completion Date
Ongoing
NCT00890916	Hand Function for Tetraplegia Using a Wireless Neuroprosthesis	11	Nov 2019
NCT02602639	Functional Electrical Stimulation with Rowing as Exercise after Spinal Cord Injury (FES)	6	Sep 2020
NCT03385005	Evaluating Neuromuscular Stimulation for Restoring Hand Movements	15	Mar 2019
NCT03495986	Spinal Cord Injury Exercise and Nutrition Conceptual Engagement (SCIENCE)	40	Jul 2022
NCT03440632	Functional Electrical Stimulation during walking cerebral palsy	25	Aug 2021
NCT00583804	Implanted Myoelectric Control for Restoration of Hand Function in Spinal Cord Injury	10	Jan 2026
Unpublished
NCT03810963	Electrically Induced Cycling and Nutritional Counseling for Counteracting Obesity After SCI	15	May 2019 (updated 10/04/19)

NCT: national clinical trial.]
________________________________________________________________________________________

Horizon BCBSNJ Medical Policy Development Process:

This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.

___________________________________________________________________________________________________________________________

Index:
Neuromuscular Electrical Stimulation (NMES) and Functional Electrical Stimulation (FES)
Neuromuscular Electrical Stimulation (NMES)
Electric Stimulation, Neuromuscular
ERGYS Exercise Equipment
FES (Functional Electrical Stimulation)
FES Power Trainer Exercise Equipment
Functional Electrical Stimulation (FES)
NeuroEDUCATOR Exercise Equipment
Parastep Ambulation System
REGYS Exercise Equipment
SpectraSTIM Exercise Equipment
NMES
WalkAide
RS-4i
Bioness NESS L300
NESS L300
ODFS Dropped Foot Stimulator
Odstock Foot Drop Stimulator

References:

1. Centers for Medicare & Medicaid Services. Decision Memo for Neuromuscular Electrical Stimulation (NMES) for Spinal Cord Injury (CAG-00153R). 2002; https://www.cms.gov/medicare-coverage-database/details/nca- decision-memo.aspx?NCAId=55&ver=7&viewAMA=Y&bc=AAAAAAAAEAAA&. Accessed April 1, 2020.

2. Mulcahey MJ, Betz RR, Kozin SH, et al. Implantation of the Freehand System during initial rehabilitation using minimally invasive techniques. Spinal Cord. Mar 2004; 42(3): 146-55. PMID 15001979

3. Mulcahey MJ, Betz RR, Smith BT, et al. Implanted functional electrical stimulation hand system in adolescents with spinal injuries: an evaluation. Arch Phys Med Rehabil. Jun 1997; 78(6): 597-607. PMID 9196467

4. Taylor P, Esnouf J, Hobby J. The functional impact of the Freehand System on tetraplegic hand function. Clinical Results. Spinal Cord. Nov 2002; 40(11): 560-6. PMID 12411963

5. Venugopalan L, Taylor PN, Cobb JE, et al. Upper limb functional electrical stimulation devices and their man-machine interfaces. J Med Eng Technol. 2015; 39(8): 471-9. PMID 26508077

6. Alon G, McBride K. Persons with C5 or C6 tetraplegia achieve selected functional gains using a neuroprosthesis. Arch Phys Med Rehabil. Jan 2003; 84(1): 119-24. PMID 12589632

7. Alon G, McBride K, Ring H. Improving selected hand functions using a noninvasive neuroprosthesis in persons with chronic stroke. J Stroke Cerebrovasc Dis. Mar-Apr 2002; 11(2): 99-106. PMID 17903863

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Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)

CPT*

64550
64565

A4595
E0731
E0744
E0745
E0764
E0770
L8680
L8685
L8686
L8687
L8688