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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.
Full description
During the first weeks after the onset of stroke, the injured brain undergoes several neural mechanisms, a process known as neuroplasticity, that intend to reorganize the neural connectivity and repair the damaged tissue around the injury region. Several studies revealed that rehabilitation during this acute period of injury would enhance the functional outcome of the paretic arm presumably by modulating the heightened neuroplastic mechanism. Specifically, it has been suggested that novel interventions that interact with the neuroplastic mechanisms of recovery are particularly needed for stroke survivors whom initial arm impairments are severe.
The rationale of this study is to explore if an EMG controlled device can be added to the acute rehabilitation for stroke subjects with severe arm deficit. The study will also investigate if the application of such a device would lead to an even better enhancement of clinical outcomes compared to standard care. Because of such neurophysiological changes during the acute phase, the study aims to correlate the neurophysiological changes with the enhancement gained as a result of practicing with an EMG controlled device in this population. Thus, test the premise that adding practice with an EMG controlled device to the acute rehabilitation of subjects with severe arm impairments acts as novel rehabilitative tool that interact with the neuroplastic mechanisms of recovery to enhance clinical outcomes for these subjects.
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Inclusion criteria
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:
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
Primary purpose
Allocation
Interventional model
Masking
10 participants in 1 patient group
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Central trial contact
Ahlam Salameh, PhD MSc; Holly B Henry
Data sourced from clinicaltrials.gov
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