Status:
COMPLETED
Functional Electrical Stimulation (FES) for Upper Extremity Recovery in Stroke
Lead Sponsor:
MetroHealth Medical Center
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Case Western Reserve University
Conditions:
Stroke, Acute
Stroke
Eligibility:
All Genders
21-89 years
Phase:
NA
Brief Summary
Stroke is the leading cause of activity limitation among older adults in the United States. NeuroMuscular Electrical Stimulation (NMES) can assist stroke survivors in regaining motor ability and decre...
Detailed Description
Stroke is the leading cause of activity limitation among older adults in the United States. NeuroMuscular Electrical Stimulation (NMES) can be used by stroke survivors who do not have enough residual ...
Eligibility Criteria
Inclusion
- Age 21-89
- Evidence of clinical symptoms from a hemorrhagic or nonhemorrhagic stroke with all symptoms from previous stroke(s) completely resolved
- Medically stable
- Less than 6 months post-stroke
- Intact skin on the hemiparetic side
- Able to follow 3-stage commands
- Able to recall 2/3 objects after 30 minutes
- Full passive ROM at the wrist and the thumb, index and long finger MCP joints on the affected side
- Presence of a detectable, volitionally-activated EMG signal from the paretic wrist or finger extensors (ECR or EDC)
- Affected wrist extensors ≤ 4 on MRC scale
- Score of ≤ 11/14 on Section C (hand) of UE portion of Fugl Meyer Assessment (FMA)
- Ability to tolerate NMES to the ECR and EDC for full wrist and finger extension
- Caregiver available to assist with the device every day (unless subject capable of using it independently
Exclusion
- History of ventricular arrythmias or any other arrythmias (i.e. fast atrial fibrillation, ventricular tachycardia, or supraventricular tachycardia) with hemodynamic instability
- History of other upper motor neuron lesion
- Absent sensation of the affected limb
- Pregnancy
- History of more than one seizure per month during the last year (or, since the stroke if no seizures prior to stroke)
- Discharge to a skilled nursing facility or long-term care facility (EXCEPTION: Subjects may be d/c'd to the 6A SNF unit at MetroHealth Medical Center)
- Uncompensated hemineglect
- Implanted stimulator (such as a pacemaker)
- Evidence of hand pain as defined by current metacarpophalangeal (MCP) joint pain upon palpation and/or wrist or MCP pain upon extension
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT00142792
Start Date
December 1 2005
End Date
March 1 2010
Last Update
March 29 2018
Active Locations (3)
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1
Edwin Shaw Rehab - Akron General Medical Center
Akron, Ohio, United States, 44312
2
University of Cincinnati College of Medicine
Cincinnati, Ohio, United States, 45267
3
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109