RecruitingNot ApplicableNCT04599036

EMG Controlled Device in Acute Rehabilitation After Acute Stroke

Myoelectrolytically Controlled Device in Acute Rehabilitation After Stroke

Sponsor

VA Office of Research and Development

Enrollment

10 participants

Start Date

Oct 7, 2020

Study Type

INTERVENTIONAL

Conditions

Stroke

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.

Eligibility

Min Age: 18 YearsMax Age: 90 Years

Inclusion Criteria10

Veterans over 18 years of age
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 Criteria19

Hemorrhagic stroke
Previous strokes affecting motor function on the opposite side.
Fugl-Meyer score of 2 on the following 3 items:
\) 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 MRI patient call button
Past history of seizures
Family history of medication refractory epilepsy
Chronic sleep deprivation, ongoing untreated sleep disorder
Pregnancy or pregnancy planning during the study period
Currently taking medications or substances that lower the threshold for onset of seizure.
Inability to understand English