Using an EMG controlled device for rehabilitation after stroke
Myoelectrolytically Controlled Device in Acute Rehabilitation After Stroke
This study is testing a new device that uses muscle signals to help stroke survivors with severe arm problems recover better during their early rehabilitation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT04599036 on ClinicalTrials.gov |
What this trial studies
This study explores the feasibility of using an EMG controlled device to enhance rehabilitation for stroke survivors with severe arm deficits. It aims to determine if this innovative technology can improve clinical outcomes beyond standard care during the acute phase of recovery. The study will assess the correlation between neurophysiological changes and the functional improvements achieved through the use of the device. Participants will engage in rehabilitation practices that leverage the device to potentially enhance neuroplasticity and recovery of arm function.
Who should consider this trial
Good fit: Ideal candidates are veterans over 18 years old who have experienced an ischemic stroke within the last 6 months and have severe arm impairments.
Not a fit: Patients who have had a hemorrhagic stroke or previous strokes affecting motor function on the opposite side may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the ability of stroke survivors to perform daily activities independently.
How similar studies have performed: While the use of EMG controlled devices in rehabilitation is a novel approach, previous studies have shown promise in enhancing recovery through innovative rehabilitative tools.
Eligibility criteria
Show full inclusion / exclusion criteria
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 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
Where this trial is running
Cleveland, Ohio
- Louis Stokes VA Medical Center, Cleveland, OH — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Ahlam Salameh, PhD MSc — Louis Stokes VA Medical Center, Cleveland, OH
- Study coordinator: Ahlam Salameh, PhD MSc
- Email: Ahlam.Salameh@va.gov
- Phone: (216) 791-3800
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.