NCT04599036Active, not recruiting
EMG Controlled Device in Acute Rehabilitation After Acute Stroke
Myoelectrolytically Controlled Device in Acute Rehabilitation After Stroke
Source: ClinicalTrials.gov · Last updated 15 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 3 (actual)
- First submitted
- 9 Oct 2020
- Start date
- 7 Oct 2020
- Primary completion date
- 30 Sept 2026
- Lead sponsor
- VA Office of Research and Development
- Diseases
- Stroke
- NCT number
- NCT04599036
What you commit to
- Study type: Interventional
- Participants enrolled: 3
- From 7 Oct 2020 to the primary completion date, 30 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous strokes affecting motor function on the opposite side.
- Currently taking medications or substances that lower the threshold for onset of seizure.
Other illness
- Hemorrhagic stroke
- Past history of seizures
- Family history of medication refractory epilepsy
- Chronic sleep deprivation, ongoing untreated sleep disorder
Other
- 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 MRI patient call button
- Pregnancy or pregnancy planning during the study period
- Inability to understand English
Who the study is looking for
- 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
Age in the registry: 18 years to 90 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Louis Stokes VA Medical Center, Cleveland, OH Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.