Electrical Stimulation for Recovery of Hand Function in Chronic Stroke Survivors

Completed

Phase 2 Results N/A

Update History

15 Apr '15
A location was updated in Cleveland.
New
The overall status was removed for MetroHealth Medical Center.
6 Oct '11
The eligibility criteria were updated.
New
Inclusion Criteria: - Age 18-80 - > 6 months of first hemorrhagic or nonhemorrhagic stroke - Able to recall 2 of 3 items after 30 minutes - MRC ≤ 4 for finger extensors on paretic side - Able to follow 3-stage commands - Functional movement of shoulder and elbow (e.g., can reach ¾ hand-to- mouth movement) of paretic side - Caregiver available to assist with device and compliance if needed - Skin intact on hemiparetic arm - Medically stable - Surface NMES trial opens hand without pain - Full volitional hand opening/closing of contralateral hand - Upper extremity hand section of FMA < 11/14 - Able to hear and respond to stimulator/cue box auditory cues - Completed occupational therapy (no concomitant OT) Exclusion Criteria: - Lack of functional PROM of the wrist or fingers of affected side - Severe shoulder or hand pain (unable to position hand in the workspace without pain) - Uncontrolled seizure disorder - Insensate forearm and/or hand - Uncompensated hemi-neglect (extinguishing to double simultaneous stimulation) - Edema of the affected forearm and/or hand - History of cardiac arrhythmias with hemodynamic instability - Cardiac pacemaker or other implanted electronic system - Pregnant - IM Botox injections in any UE muscle in the last 3 months - Parkinson's disease, SCI, TBI, or MS - Ipsilateral motor neuron lesion
Old
Inclusion Criteria: - Age 18-80 - > 6 months of first hemorrhagic or nonhemorrhagic stroke - Able to recall 2 of 3 items after 30 minutes - MRC ? 4 for finger extensors on paretic side - Able to follow 3-stage commands - Functional movement of shoulder and elbow (e.g., can reach ¾ hand-to- mouth movement) of paretic side - Caregiver available to assist with device and compliance if needed - Skin intact on hemiparetic arm - Medically stable - Surface NMES trial opens hand without pain - Full volitional hand opening/closing of contralateral hand - Upper extremity hand section of FMA < 11/14 - Able to hear and respond to stimulator/cue box auditory cues - Completed occupational therapy (no concomitant OT) Exclusion Criteria: - Lack of functional PROM of the wrist or fingers of affected side - Severe shoulder or hand pain (unable to position hand in the workspace without pain) - Uncontrolled seizure disorder - Insensate forearm and/or hand - Uncompensated hemi-neglect (extinguishing to double simultaneous stimulation) - Edema of the affected forearm and/or hand - History of cardiac arrhythmias with hemodynamic instability - Cardiac pacemaker or other implanted electronic system - Pregnant - IM Botox injections in any UE muscle in the last 3 months - Parkinson's disease, SCI, TBI, or MS - Ipsilateral motor neuron lesion