mGain - sEMG-based Gamified Therapy for Improved Upper Limb Rehabilitation
Status unconfirmed · Not applicable
Conditions studied: Upper Limb Weakness Due to Central Neurologic Injury, Upper Limb Weakness Due to Peripheral Neurologic Injury, Upper Limb Weakness Due to Nerve Reconstruction, Upper Limb Weakness Due to Tendon Transfer Surgery, Stroke, Upper Limb Amputation
In brief
The purpose of this Phase I study is to conduct a pilot clinical trial using a mobile app-connected, wire-free surface electromyography (sEMG) system, called mGain, that provides biofeedback-based therapy in individuals with upper limb weakness due to neurologic injury or with upper limb amputation. Our overarching hypothesis is that the mGain wireless sEMG device and mobile therapeutic gaming environment will demonstrate improved adherence to therapy when compared to standard of care and will be feasible, acceptable, and usable in individuals with upper limb weakness or limb amputation. All participants will undertake four weeks of therapy. Conducting therapy five days a week for 30 minutes a day. In addition, participants will have an initial and final assessment visit at a study site, with each visit expected to last 1-2 hours.
Key facts
- Study ID
- NCT06023316
- Run by
- Orthocare Innovations, LLC
- People needed
- 30
- Starts
- 2023-08-08
- Expected to finish
- 2024-03-01
- Last updated by the study team
- 2023-10-10
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age 18 years or older
- Upper limb weakness due to central or peripheral neurologic injury, stroke, or nerve reconstruction or tendon transfer surgery within one year; or upper limb amputation (e.g., transradial or transhumeral)
- Muscle strength of three or less on the Medical Research Council Manual Muscle Testing grading scale in any of the following (as appropriate for individuals with intact limbs): shoulder abduction, elbow flexion, elbow extension, wrist extension, wrist flexion, or finger extension
- Access to and willingness to use smart phone or tablet
- Able to tolerate participation in activity for at least 30 minutes of therapy exercises per day for five days per week
- Able to provide written informed consent for study participation
You may not qualify if…
- Not able to read and understand English
- Pregnancy
- History of prior central or peripheral neurologic injury or neuromuscular condition
- No muscle activation detectable by the mGain sEMG sensor
- Progressive neurologic deficit
- Impaired dexterity on the contralateral side such that participant is unable to use the device
- Spasticity with modified Ashworth score of three or greater
- Severe joint contracture (>50% of available range)
- Sensitive skin that would not tolerate wearing the mGain sEMG sensor
- Medical instability
- Confounding injury, musculoskeletal issues, or cognitive issues that limit effective participation
Where it is running
- Orthocare Innovations, LLC — Edmonds, Washington, United States (enrolling)
Full record on ClinicalTrials.gov
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