Status:
COMPLETED
Electrical Stimulation for Recovery of Hand Function in Chronic Stroke Survivors
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
Hemiparesis
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Impaired hand function is one of the most frequently persisting consequences of stroke. The purpose of this study is to compare two different treatments -- Contralataterally Controlled Functional Elec...
Detailed Description
Hemiparesis of the upper limb is one of the most serious and most common impairments resulting from stroke. Approximately 75% of the over 750,000 strokes that occur annually in the United States cause...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00891319
Start Date
January 1 2009
End Date
May 1 2015
Last Update
November 6 2017
Active Locations (1)
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1
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109