DESCRIPTION
The upper limb myoelectric orthosis (e.g., MyoPro®) has been proposed as an assist device to enable individuals to self-initiate and control movements of a partially paralyzed or weakened arm and to regain the ability to perform activities of daily living. Sensors built into the custom wearable device detect the electrical activity of muscles at rest in the affected arm in four locations - bicep/triceps and the forearm flexor/extensor muscle groups. These signals are amplified when a user initiates movement, driving small motors which allow the individual to extend/flex their elbow and open/close their thumb and fingers. The intent of the upper limb myoelectric orthosis device is to increase functional capacity and retain range of motion.
POLICY
The use of myoelectric upper limb orthosis for all indications, including but not limited to, stroke, trauma, or neurological disorders is considered investigational.
IMPORTANT REMINDERS
Any specific products referenced in this policy are just examples and are intended for illustrative purposes 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. These examples are contained in the parenthetical e.g. statement.
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ADDITIONAL INFORMATION
The evidence base for this technology consists of a few small studies with inconsistent outcomes. Additional studies with larger numbers of participants are needed that show consistent improvements in relevant outcome measures to determine the technology’s effect.
SOURCES
BlueCross BlueShield Association. Evidence Positioning System. (4:2024). Myoelectric prosthetic and orthotic components for the upper limb (1.04.04). Retrieved June 10, 2024 from www.bcbsaoca.com/eps. (13 articles and/or guidelines reviewed)
McCabe, J.P., Henniger, D., Perkins, J., Skelly, M., Tatsuoka, C., & Pundik, S. (2019). Feasibility and clinical experience of implementing a myoelectric upper limb orthosis in the rehabilitation of chronic stroke patients: A clinical case series report. PLoS One, 14 (4), e0215311. (Level 4 evidence)
National Institute for Health and Care Excellence. (2013; updated 2023). Stroke rehabilitation in adults. Retrieved June 11, 2024 from www.nice.org.uk/guidance/cg162.
Page, S., Hill, V., & White, S. (2013). Portable upper extremity robotics is as efficacious as upper extremity rehabilitative therapy: a randomized controlled pilot trial. Clinical Rehabilitation, 27 (6), 494-503. (Level 2 evidence)
Peters, H., Page, S., & Persch, A. (2017). Giving them a hand: wearing a myoelectric elbow-wrist-hand orthosis reduces upper extremity impairment in chronic stroke. Archives of Physical Medicine and Rehabilitation, 98 (9), 1821-1827. Abstract retrieved May 17, 2017 from PubMed database.
Pundik, S., McCabe, J., Kesner, S., Skelly, M., & Fatone, S. (2020). Use of a myoelectric upper limb orthosis for rehabilitation of the upper limb in traumatic brain injury: A case report. Journal of Rehabilitation and Assistive Technologies Engineering, 7, doi: 10.1177/2055668320921067. (Level 4 evidence)
U.S. Food and Drug Administration. (2007, April). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K062631. Retrieved May 18, 2017 from https://www.accessdata.fda.gov.
Willigenburg, N., McNally, P., Hewett, T., & Page, S. (2017). Portable myoelectric brace use increases upper extremity recovery and participation but does not impact kinematics in chronic, poststroke hemiparesis. Journal of Motor Behavior, 49 (1), 46-54. (Level 2 evidence)
ORIGINAL EFFECTIVE DATE: 11/14/2015
MOST RECENT REVIEW DATE: 7/11/2024
ID_BT
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