EMG Controlled Device in Acute Rehabilitation After Acute Stroke

Launched by VA OFFICE OF RESEARCH AND DEVELOPMENT · Oct 16, 2020

Keywords

ClinConnect Summary

This clinical trial is looking to see how effective a special device that uses electrical signals from the muscles can be in helping people who have suffered a stroke regain the use of their arms. Stroke can leave many people with difficulty moving their arms, even after they have undergone rehabilitation. The study is testing whether using this device in the early stages of recovery can improve the ability of stroke survivors to perform everyday activities, like getting dressed or eating, more independently than traditional rehabilitation methods alone.

To participate, you need to be a veteran over 18 years old who has had an ischemic stroke (the most common type, caused by a blockage in blood flow to the brain) within the last 6 months. You should also have some movement in your arm and be able to produce certain muscle signals that the device can detect. If you qualify and choose to join the study, you’ll use the device during your rehabilitation sessions and help researchers understand how well it works. It’s important to note that some people may not be eligible due to specific medical conditions, so talking to your doctor would be a good first step if you're interested.

Gender

ALL

Eligibility 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