Medical Policy

This document addresses the use of upper extremity myoelectric orthoses (for example, the MyoPro^®, MyoMo, Inc., Cambridge, 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

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.

In 2013, Page and others published the results of a small randomized controlled trial (RCT) involving 16 subjects with chronic, stable, moderate upper extremity impairment. Subjects 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 subjects 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 subjects diagnosed with single cerebrovascular accident and moderate to severe arm paresis. Subjects were randomly assigned into two 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 two 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 subjects 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, subjects 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 subjects reported skin irritation or technical difficulties during the study. Two subjects dropped out due to technical problems.

Willigenburg and colleagues (2016) conducted an 8-week RCT to compare behavioral and kinematic outcomes of post-stroke survivors with moderate upper extremity impairment. The researchers assigned 12 subjects 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 subjects who had moderate upper extremity impairment following stroke. Each subject performed a series of tests including the Fugl-Meyer Assessment and the Box and Blocks test. The subjects 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 subjects with or without a myoelectric brace. Well-designed studies with large samples and control groups are needed.

Page and colleagues (2020) published a small randomized controlled trial involving 34 subjects exhibiting chronic, moderate, stable, post-stroke, upper extremity hemiparesis. The subjects 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 subjects, 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.

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 (2023a). 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 patients 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 didn't 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 (2023b) completed a three-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 orthosisand examined at four distinct intervals - two weeks, one month, two months, and three 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.

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. Chang SR, Hofland N, Chen Z, Kovelman H, 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 Mar 21.
2. Chang SR, Hofland N, Chen Z, Tatsuoka C, et al. Myoelectric arm orthosis assists functional activities: A 3-month home use outcome report. Arch Rehabil Res Clin Transl. 2023 Jul 13;5(3):100279.
3. 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.
4. 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.
5. Page S, Griffin C, White S. Efficacy of myoelectric bracing in moderately impaired stroke survivors: A randomized, controlled trial. J Rehabil Med. 2020 Feb 7; 52(2):jrm00017.
6. 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.
7. 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.
8. 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.

Federal and State law, as well as contract language, including definitions and specific contract provisions/exclusions, take precedence over Medical Policy and must be considered first in determining eligibility for coverage. The member’s contract benefits in effect on the date that services are rendered must be used. Medical Policy, which addresses medical efficacy, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and we reserve the right to review and update Medical Policy periodically.

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