Status:
UNKNOWN
mGain - sEMG-based Gamified Therapy for Improved Upper Limb Rehabilitation
Lead Sponsor:
Orthocare Innovations, LLC
Collaborating Sponsors:
National Institute on Disability, Independent Living, and Rehabilitation Research
Conditions:
Upper Limb Weakness Due to Central Neurologic Injury
Upper Limb Weakness Due to Peripheral Neurologic Injury
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 the...
Detailed Description
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 si...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
August 8 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06023316
Start Date
August 8 2023
End Date
March 1 2024
Last Update
October 10 2023
Active Locations (1)
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1
Orthocare Innovations, LLC
Edmonds, Washington, United States, 98020