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Upper Limb Weakness Due to Central Ne...
+5

mGain - sEMG-based Gamified Therapy for Improved Upper Limb Rehabilitation

Sponsored by Orthocare Innovations, LLC

About this trial

Last updated 2 years ago

Study ID

mGain-001

Status

Recruiting

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended a year ago

What is this trial about?

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.

What are the participation requirements?

Yes

Inclusion Criteria

- 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

No

Exclusion Criteria

- 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

Locations

Location

Status

Recruiting