Status:
COMPLETED
Functional Electrical Stimulation for Footdrop in Hemiparesis
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
Hemiplegia
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The objective of this research is to determine if electrical stimulation can improve the strength and coordination of the lower limb muscles, and the walking ability of stroke survivors. The knowledg...
Detailed Description
Hemiplegia is a major consequence of stroke and contributes significantly to the physical disability of stroke survivors. Foot-drop, or inability to dorsiflex the paretic ankle during the swing phase ...
Eligibility Criteria
Inclusion
- Stroke survivors \>90 days from most recent clinical hemorrhagic or nonhemorrhagic stroke
- Age: 18-80 years
- Unilateral hemiparesis
- Medically stable
- Sufficient endurance \& motor ability to ambulate at least 30 feet continuously with minimal assistance \[requiring contact guard to no more than 25% physical help\] or less without the use of an AFO
- Berg Balance Scale score of 24 or greater without any assistive devices
- Ankle dorsiflexion strength of no greater than 4/5 on the Medical Research Council (MRC) scale while standing
- Demonstrate foot-drop during ambulation such that gait instability \[need for supervision, physical assistance or assistive device (cane, walker) to maintain balance or prevent falls\] or inefficient gait patterns \[gait pattern manifesting "dragging" or "catching" of the affected toes during swing phase of gait, or use of compensatory strategies such as circumducting the affected limb, vaulting with the unaffected limb or hiking the affected hip to clear the toes\] are exhibited
- Ankle dorsiflexion to at least neutral while standing in response to NMES of the common peroneal nerve without painful hypersensitivity to the NMES
- If using an AFO, willing to terminate its use and comply with study requirements
Exclusion
- Require an AFO to maintain knee stability (prevention of knee flexion collapse) during stance phase of gait
- Edema of the affected lower limb which interferes with the safe and effective use of a peroneal nerve stimulator
- Skin breakdown of the affected lower limb which interferes with the safe and effective use of a peroneal nerve stimulator
- Absent sensation of the affected lower limb
- History of potentially fatal cardiac arrhythmias, such as ventricular tachycardia, supraventricular tachycardia, and rapid ventricular response atrial fibrillation with hemodynamic instability
- Demand pacemakers or any other implanted electronic systems
- Pregnant women
- Uncontrolled seizure disorder
- Parkinson's Disease
- Spinal cord injury
- Traumatic brain injury with evidence of motor weakness
- Multiple sclerosis
- Fixed ankle plantar flexor contracture
- Peroneal nerve injury at the fibular head as the cause of foot-drop
- Uncompensated hemineglect
- Severely impaired cognition and communication
- Painful hypersensitivity to NMES of the common peroneal nerve
- Inadequate social support (potential unlikeliness to comply with treatment \& follow-up)
- History of Botulinum toxin (Botox) injection to either of the lower extremities within the 3 month period preceding study entry
- Knee hyperextension (genu recurvatum) that cannot be adequately corrected with peroneal nerve stimulation
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 2 2010
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT00148343
Start Date
July 1 2005
End Date
August 2 2010
Last Update
June 1 2018
Active Locations (1)
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1
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109