Medical Policy

This document addresses the use of upper extremity myoelectric orthoses (for example, the MyoPro^®, Myomo, Inc., Burlington, MA), which are intended to augment the function of individuals with upper arm weakness or partial paralysis due to neurological conditions, trauma, or other problems. Such devices use neurologic sensors, microprocessor units, and electric motors to provide self-initiated movement of the affected limb. These devices should not be confused with prosthetic devices, which are intended to replace or compensate for a missing limb or other body part.

Note: For more information regarding upper extremity myoelectric devices, please refer to:

• CG-OR-PR-05 Myoelectric Upper Extremity Prosthetic Devices

Note: For a high-level overview of this document, please see “See Members and Families Section” below. 

Investigational and Not Medically Necessary:

The use of myoelectric upper extremity orthotic devices is considered investigational and not medically necessary for all indications, including but not limited to use by individuals with stroke, trauma, or neurological disorders.

This document describes clinical studies and expert recommendations, and explains whether upper extremity myoelectric orthoses are clinically appropriate. The following summary does not replace the medical necessity criteria or other information in this document. The summary may not contain all of the relevant criteria or information. This summary is not medical advice. Please check with your healthcare provider for any advice about your health.

Key Information

Myoelectric upper extremity orthoses are braces worn on the arm to help people with weakness or partial immobility of their arm. These devices use sensors to detect small muscle signals which are sent to a small motor which helps move the arm in the way the person is trying to move it. They are different from prosthetic devices, which replace a missing limb. Myoelectric orthoses are meant to help people who have had a stroke, injury, or other brain or nerve problem.

What the Studies Show

Myoelectric arm braces are designed to help people move a weak arm by using their own muscle signals to operate motors to move the arm as the person wants it to. When a person tries to bend or lift their arm, the brace senses the signal in the muscles and powers a motor in the device to help complete the motion. The goal is to improve daily activities such as eating, reaching, or lifting. Possible risks include skin irritation, discomfort, and technical problems with the device. Some people in studies stopped using the brace because of these issues. As with any device, there may be inconvenience, maintenance needs, and frustration if the device does not work as expected.

Several small studies have tested devices such as the MyoPro in people who have had a stroke. Some studies showed small improvements in arm movement scores when people wore the brace. However, many studies included only a small number of participants, had short follow up times, or did not compare the brace to strong control groups. In some studies, the brace worked about the same as standard repetitive task practice therapy. In others, improvements did not meet the level considered meaningful for daily life. Researchers often concluded that larger and better designed studies are needed to know if these devices improve health or function in a lasting way. Because of these limits, these types of devices have not been proven to improve outcomes beyond standard therapy.

Is this Clinically Appropriate?

These types of devices are not clinically appropriate because they have not been proven to improve health. Studies so far have been small, short term, or had design limits. Some showed small score changes, but these changes were often similar to standard therapy or did not clearly improve daily function. Researchers have stated that larger, high quality studies are needed to know if myoelectric arm braces lead to meaningful and lasting improvement. Unnecessary or unproven tests or treatments can lead to treatment that does not help.

(Return to Description/Scope)

Summary

This document addresses upper extremity myoelectric orthotic devices designed to augment voluntary movement in individuals with arm weakness or partial paralysis due to stroke, trauma, or neurologic conditions. The available evidence includes randomized and observational studies evaluating devices such as the MyoPro, noting small sample sizes, short follow-up periods, and limited evidence demonstrating meaningful or sustained functional improvement beyond conventional therapy. Current rehabilitation literature and professional society guidance emphasize structured, task-specific therapy as the foundation of post-stroke upper extremity recovery, and do not include routine recommendations for myoelectric orthotic devices as standard treatment.

Discussion

In 2013, Page and others published the results of a small randomized controlled trial (RCT) involving 16 participants with chronic, stable, moderate upper extremity impairment. Participants were assigned to undergo administered repetitive task-specific practice with or without the use of the Myomo e100 myoelectric upper limb orthosis (n=8 in each group). After the intervention, both groups exhibited nearly identical Fugl-Meyer Assessment of Motor Recovery After Stroke score increases of approximately 2.1 points; the group using the orthotic exhibited larger score changes on all but one of the Canadian Occupational Performance Measure and Stroke Impact Scale subscales, including a 12.5 point increase on the Stroke Impact Scale recovery subscale. The authors conclude that therapist-supervised repetitive task-specific practice integrating the Myomo device is as efficacious as manual practice in participants with moderate upper extremity impairment. The generalizability of this study is limited by the small sample size, as well as other methodological issues. Further investigation on the clinical utility and health outcomes is needed.

Klamroth-Marganska and colleagues (2014) conducted an 8-week prospective, multicenter, parallel-group randomized trial involving 77 participants diagnosed with single cerebrovascular accident and moderate to severe arm paresis. Participants were randomly assigned into 2 groups: robotic therapy (n=39) or conventional therapy (n=38). Both groups applied therapy 3 times a week for 8 weeks (total of 24 sessions). The primary outcome showed a significant difference in the Fugl-Meyer Assessment of the upper extremity motor function (p=0.041). An increase of 5 or more points was noted in 34% of the robotic therapy group and 26% of the conventional therapy group. Lesser progress was noted in the mean strength from the robotic therapy group (p=0.017). The researcher noted that the difference between the 2 groups was small (0.78 points in the Fugl-Meyer Assessment of the upper extremity) and significance was weak (p=0.41). Before a final conclusion can be drawn, additional investigation with severely affected participants should be conducted.

In a 2015 pilot study, Kim and colleagues used a nonrandomized pretest-posttest design to evaluate an upper extremity myoelectric orthotic on 11 post-stroke individuals. After undergoing supervised training on the use of a Myomo mPower 1000 myoelectric upper extremity orthotic, participants completed and logged self-initiated home therapy sessions for 6 weeks. The orthotic was fitted with an accelerometer that recorded motion data. Paired t-test results showed a statistically significant improvement on the Fugl-Meyer Assessment Upper Extremity scale (t=3.32; p=0.01), the Motor Activity Log Amount of Use subscale (t=4.40; p=0.002), and the Motor Activity Log How Well subscale (t=4.02; p=0.004). At a 12-week follow-up, statistical significance dropped but was still present for the Motor Activity Log Amount of Use subscale (t=2.61; p=0.035) and Motor Activity Log How Well subscale (t=2.47; p=0.043). Results for the Arm Ability Test, Box and Blocks test and Modified Ashworth scale were not statistically significant and none of the results from the study met the minimal clinically important difference. Limitations of the study include a small sample size, limited capture of data by the accelerometer, and lack of a control group. Some participants reported skin irritation or technical difficulties during the study. Additionally, 2 participants dropped out due to technical problems.

Willigenburg and colleagues (2017) conducted an 8-week RCT to compare behavioral and kinematic outcomes of post-stroke survivors with moderate upper extremity impairment. The researchers assigned 12 participants to either the standard treatment of repetitive task-specific practice (n=5) or the use of the Myomo e100 myoelectric upper extremity orthotic with repetitive task-specific practice (n=7). The individuals who used the myoelectric orthotic scored higher on the Stroke Impact Scale which included self-reported measurements on recovery perceptions (p=0.032) and activities of daily living (p=0.061). The standard treatment group scored higher on kinematic peak hand velocity during the reach-up task (p=0.018). No significant differences between the groups were found on the remaining kinematic outcomes which included elbow extension and shoulder flexion. The researchers concluded the use of the myoelectric orthotic increases the perception of improvement; however, myoelectric orthotics were as effective as the standard manual treatment when evaluating kinematics. Limits of the study include small sample size, stability of treatment issues and short duration. The researchers note that this is the first known study of its kind on portable myoelectric orthotic kinematics and further investigation is needed.

Peters and colleagues (2017) performed an industry designed and supported observational cohort study to test behavioral outcomes on 18 participants who had moderate upper extremity impairment following stroke. Each participant performed a series of tests including the Fugl-Meyer Assessment and the Box and Blocks test. The participants completed the tests in the same order with and without wearing a MyoPro Motion-G myoelectric upper extremity orthotic. The Fugl-Meyer scores were an average of 8.72 points higher (p<0.0001) when participants wore the orthotic and the scores exceeded the minimal clinically important difference. In addition, Box and Blocks test scores were higher for the individuals wearing the orthotic (z=3.42; p<0.001). The researchers found that statistically significant results were demonstrated for many activities including elbow extension, grasping items, finger extension, and manual dexterity. Limitations include a small sample size and a change in study design. The researchers note that this is the first study comparing participants with or without a myoelectric brace. Well-designed studies with large samples and control groups are needed.

Page and colleagues (2020) published a small RCT involving 34 participants exhibiting chronic, moderate, stable, post-stroke, upper extremity hemiparesis. The participants were randomized by a computer-generated number table to receive: Myomo combined with repetitive, task-specific practice; repetitive, task-specific practice only; or Myomo therapy only. Of the 34 participants, 31 completed the study and were analyzed. Using the Fugl-Meyer Impairment scale (FM), the following score change was noted: Myomo combined with repetitive, task-specific practice = +2.37; repetitive, task-specific practice only = +2.84; and Myomo only = +2.78. Using the Arm Motor Activity Test (AMAT), the following score change was noted: Myomo combined with repetitive, task-specific practice = +1.75; repetitive, task-specific practice only = +2.56; and Myomo only = +0.86. The researchers concluded that further studies are needed to show if myoelectric bracing may be a possible alternative to upper extremity training.

Pundik (2022) evaluated the MyoPro myoelectric arm orthosis as an adjunct to motor learning-based therapy in individuals with chronic upper limb deficits following stroke or traumatic brain injury. In this prospective single-arm pilot study of 13 participants, participants underwent a structured program consisting of 9 weeks of in-clinic therapy (18 sessions) followed by a 9-week home exercise phase, with repeated assessments across impairment, functional, and participation domains. The intervention resulted in clinically meaningful improvements in motor impairment, including a mean increase of approximately 7.5 points on the Fugl-Meyer scale (exceeding the minimal clinically important difference), along with significant improvements in muscle tone (Modified Ashworth Scale), range of motion, and functional task performance. Improvements were observed early during the in-clinic phase and maintained during home use, and participants reported high satisfaction with the device and perceived functional gains in daily activities. The findings suggest that combining a myoelectric orthosis with motor learning principles may enhance rehabilitation outcomes while requiring fewer in-person therapy hours than traditional high-dose programs. Limitations included a small sample size, lack of a control group, and a single-arm design without blinding, limiting causal inference and generalizability; participants were heterogeneous in diagnosis and baseline impairment; and variability in device use and adherence may have influenced outcomes. Additionally, the pilot nature of the study and absence of long-term follow-up beyond 18 weeks highlight the need for larger RCTs to confirm efficacy and durability of this approach.

A retrospective study of 19 individuals with upper extremity impairment due to stroke who had received a custom fabricated MyoPro arm brace was conducted by Chang and colleagues (2024). Participants' progress was measured with the use of the DASH (Disability of the Arm, Shoulder, and Hand) score before and after use of the MyoPro. The results of the study showed a significant improvement in DASH scores with the MyoPro, with a mean change of 18.07 points and a median duration of 11.7 months post MyoPro fitting. The study indicated an increase of upper extremity function and independence in chronic stroke survivors, suggesting the MyoPro as a promising recovery tool for individuals who have post-stroke upper limb impairment. The study had several limitations. First, the study did not control for participants' engagement in therapy, medication use, home exercise routines, or MyoPro device use, all of which could impact their reported functional changes. Additionally, the study was conducted remotely, which hindered the ability to record strength measurements. It had a small sample size, and it did not categorize participants based on their stroke type, location, or severity. The authors noted that future studies should focus on a larger sample size and introducing a comparative group.

Chang and colleagues (2023) completed a 3-month prospective single-arm cohort observational study to compare task performance in individuals with upper limb impairments with and without a myoelectric arm orthosis. During this period, 18 participants were provided with a myoelectric orthosis and examined at 4 distinct intervals - 2 weeks, 1 month, 2 months, and 3 months after receiving their equipment. In these follow-up evaluations, they undertook four standard tasks that are typically performed in daily life. The study found that participants had higher rates of task completion and greater overall success when wearing the MyoPro compared to when not wearing it. However, it was noted that the small sample size and lack of prescribed training or therapy may have affected the results. The authors concluded that further studies should employ a broader participant pool to pinpoint the predictors of functionality enhancement with MyoPro and over an extended timeframe to establish the best training duration for practical application, and identify the tasks it assists or hinders.

Richards (2025) conducted a systematic review evaluating the use of upper extremity myoelectric orthoses for individuals with stroke or traumatic brain injury, examining both compensatory (functional support during use) and restorative (motor recovery) applications. Across 10 studies (11 reports), most of which were non-randomized, findings consistently showed that upper extremity myoelectric orthoses improve task performance when used as a compensatory device, enabling individuals to complete more activities or portions of activities such as feeding, grasping, and object manipulation. Evidence for restorative benefit was mixed, with some studies demonstrating clinically meaningful improvements in motor impairment while others, particularly randomized data, found no added benefit compared with task practice alone. Greater improvements tended to be associated with higher baseline motor function and higher therapy dose, while severely impaired individuals showed less consistent benefit. Limitations include small, non-randomized trials with moderate-level evidence, heterogeneity in design, populations, devices and outcome measures. There was variability in therapy intensity, home use, and device features (for example, presence of hand component or electrical stimulation). Additionally, the review was limited to recent publications and select languages, and potential conflicts of interest (industry involvement) were noted. Larger, well-controlled randomized studies to clarify effectiveness and identify which individuals are most likely to benefit are needed.

Androwis (2025) conducted a randomized pilot study to evaluate the effectiveness of a myoelectric-powered wearable orthosis (MPWO, MyoPro) for improving upper extremity function in individuals with chronic incomplete cervical spinal cord injury. At the onset, 10 participants were randomized to clinic-only MPWO, home-plus-clinic MPWO, or traditional occupational therapy, with all groups completing 18 sessions over 6 weeks. Participants using MPWO demonstrated substantial improvements in handgrip active range of motion (approximately 30-37%) and grip strength (approximately 28-30%) on the trained limb, with the home-plus-clinic group generally showing the greatest gains. Modest improvements were also observed in the contralateral limb, suggesting a possible cross-education effect, while the control group showed minimal changes. These findings suggest that MPWO-assisted therapy, particularly when combined with home use, may enhance motor recovery and functional hand performance in this population. Limitations include a small sample size with group imbalances, limiting statistical power and generalizability; outcome assessors were not blinded, introducing potential bias; and follow-up was limited to immediate post-intervention, with no assessment of long-term durability. Additionally, the study focused on motor outcomes without standardized measures of activities of daily living or quality of life, making it unclear whether improvements translated into meaningful functional gains. As a pilot trial, these results are preliminary and require confirmation in larger, well-controlled studies.

Upper extremity myoelectric orthoses (for example, the MyoPro) are devices that combine the structure of a standard arm orthotic device with the microprocessors, muscle sensors and electric motor of a myoelectric device. This type of device is designed to enable individuals to self-initiate and control movements of a partially paralyzed or weakened arm using their own muscle signals. When the user tries to bend their arm, sensors in the brace detect the weak muscle signal, which activates the motor to move the arm in the desired direction. The user is completely controlling their own arm; the brace amplifies their weak muscle signal to help bend and move their arm. It has been proposed that with the brace, a paralyzed individual, such as one who has suffered a stroke or other neuromuscular disorder, may be able to perform activities of daily living including feeding, reaching, and lifting.

Orthosis: An orthopedic appliance or apparatus used to support, align, prevent, or correct deformities, or to improve function of movable parts of the body. These types of devices are not prosthetic devices, which are intended to replace or compensate for a missing limb or other body part.

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services are Investigational and Not Medically Necessary:
For the following procedure codes; or when the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

Peer Reviewed Publications:

1. Androwis GJ, Engler A, Craven C, et al. Effectiveness of myoelectric wearable orthoses for upper extremity functional recovery in spinal cord injury- a pilot study. J Neuroeng Rehabil. 2025; 23(1):6.
2. Chang SR, Hofland N, Chen Z, et al. Improved disabilities of the arm, shoulder and hand scores after myoelectric arm orthosis use at home in chronic stroke: a retrospective study. Prosthet Orthot Int. 2024; 48(3):267-275.
3. Chang SR, Hofland N, Chen Z, et al. Myoelectric arm orthosis assists functional activities: a 3-month home use outcome report. Arch Rehabil Res Clin Transl. 2023; 5(3):100279.
4. Kim GJ, Rivera L, Stein J. Combined clinic-home approach for upper limb robotic therapy after stroke: a pilot study. Arch Phys Med Rehabil. 2015; 96(12):2243-2248.
5. Klamroth-Marganska V, Blanco J, Campen K, et al. Three-dimensional, task-specific robot therapy of the arm after stroke: a multicentre, parallel-group randomised trial. Lancet Neurol. 2014; 13(2):159-166.
6. Page S, Griffin C, White S. Efficacy of myoelectric bracing in moderately impaired stroke survivors: a randomized, controlled trial. J Rehabil Med. 2020; 52(2):jrm00017.
7. Page SJ, Hill V, White S. Portable upper extremity robotics is as efficacious as upper extremity rehabilitative therapy: a randomized controlled pilot trial. Clin Rehabil. 2013; 27(6):494-503.
8. Peters HT, Page SJ, Persch A. Giving them a hand: wearing a myoelectric elbow-wrist-hand orthosis reduces upper extremity impairment in chronic stroke. Arch Phys Med Rehabil. 2017; 98(9):1821-1827.
9. Pundik S, McCabe J, Skelly M, et al. Myoelectric arm orthosis in motor learning-based therapy for chronic deficits after stroke and traumatic brain injury. Front Neurol. 2022; 13:791144.
10. Richards LG, Sethi A, Paluselli M, Cramer SC. Use of myoelectric orthosis after stroke or traumatic brain injury: a systematic review. Top Stroke Rehabil. 2026; 33(3):324-337.
11. Willigenburg NW, McNally MP, Hewett TE, Page SJ. Portable myoelectric brace use increases upper extremity recovery and participation but does not impact kinematics in chronic, poststroke hemiparesis. J Mot Behav. 2017; 49(1):46-54.

Myomo
MyoPro

The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

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