Active — Not RecruitingNot Applicable

EMG Controlled Device in Acute Rehabilitation After Acute Stroke

United States3 participantsStarted 2020-10-07

Plain-language summary

Stroke is a medically relevant problem for the aging population. Individuals with stroke experience a high amount of arm functional deficits despite receiving rehabilitation. Functional deficits can be improved by combining rehabilitation with innovative rehabilitative tools that target the brain mechanisms that guide the recovery early after stroke. This study aims to explore the feasibility of implementing an EMG controlled device in the acute rehabilitation for stroke survivors with severe arm deficit. This study will determine if adding such a technology improve the clinical outcomes for subjects with severe arm impairments beyond the levels achieved by standard care in attempt to increase their chances to independently perform activities of daily living.

Who can participate

Age range18 Years – 90 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Veterans over 18 years of age * 2 days to 6 months since the onset of ischemic stroke * Adequate range of motion at the elbow, forearm, wrist, and hand to wear the device. * Ability to generate volitional, consistent, and detectable EMG signals from the upper arm and forearm sensor sites with wrist in neutral or flexed positions as detected by the Myopro software * MAS score 3 for the biceps, triceps, supinators and pronators of the impaired arm * Able to read and comprehend the English language * Able to follow directions * Medically and psychologically stable. Healthy Controls: Over 18 years of age No history of neurological or muscular problems that affect arm function Exclusion Criteria: Hemorrhagic stroke * Previous strokes affecting motor function on the opposite side. * Fugl-Meyer score of 2 on the following 3 items: 1\) finger mass extension, 2) grasp #1 test, and 3) shoulder flexion 90 - 180 degrees, elbow at 0 degree, and forearm neutral. * Shoulder subluxation, pain or dislocation * Shoulder passive range of motion \< 45 degrees in flexion and abduction * Fixed upper limb contractures on the impaired arm and hand * Unable to safely support the weight of their arm plus 4 lbs (1.82 kg; the weight of the device) without pain even with arm supported. * Skin rash or open wound on impaired arm * Involuntary movements of the impaired arm * Pacemaker or other implanted devices * Metal in the skull * Claustrophobia, or inability to operate the…

What they're measuring

Changes in arm impairment using Fugl-Meyer assessment (FMA)

Timeframe: Change from Baseline arm impairment after 6 weeks

Trial details

NCT IDNCT04599036

SponsorVA Office of Research and Development

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2026-09-30