Status:
COMPLETED
Neural Prostheses and Gait Performance: Model-Based Strategies
Lead Sponsor:
VA Office of Research and Development
Conditions:
Hemiplegia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this research is to find the optimal patterns of functional electrical stimulation (FES) of muscles in the lower legs that will improve walking ability in those who have had a stroke an...
Detailed Description
The study aims to find the optimal patterns of functional electrical stimulation (FES) of muscles in the lower legs that will improve walking ability in those who have had a stroke and at the same tim...
Eligibility Criteria
Inclusion
- This study includes stroke survivors greater than 18 years of age, \>180 days from first clinical hemorrhagic or nonhemorrhagic stroke with:
- Unilateral hemiparesis with sufficient endurance and motor ability to ambulate \>30 feet continuously without an AFO requiring no more than 25% physical help
- Berg Balance Scale score \>23 without assistive devices
- Standing ankle dorsiflexion strength of \<4/5
- Foot-drop during ambulation with gait instability or inefficient gait defined as supervision need
- Possible use of physical assistance or assistive device (cane, walker)
- Evidence of foot-drop as seen by "dragging" or "catching" of affected toes during limb swing or circumducting affected limb
- Vaulting of the unaffected limb or hiking the affected hip to clear toes.
- Intact and electrically ex-citable lower motor neurons
- Ankle dorsiflexion to at least neutral while standing with electrical stimulation of common peroneal and tibial nerves without painful hypersensitivity to stimulation
- Adequate social support and stability
- Medically stable with intact skin in affected lower limb
- Willingness to comply during research procedures
- No systemic co-morbidities
- No history of potentially fatal cardiac arrhythmias i.e. ventricular tachycardia, supraventricular tachycardia and rapid ventricular response atrial fibrillation with hemodynamic instability
- No psychological problems or chemical dependency
- No acute medical complications such as depression or chronic anxiety requiring long term pharmacological therapy. Able-bodied controls must be of similar age, body mass and stature as those with hemiparesis and must be free of any medical and disabling orthopedic problems.
Exclusion
- In addition to failure to meet the inclusion criteria, participants will be excluded from the study for the following:
- Requires an ankle foot orthosis (AFO) to prevent knee flexion collapse in stance
- Excessive edema of affected extremity
- Absent sensation in affected 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 implanted electronic systems
- Pregnancy
- Uncontrolled seizure disorder
- Ipsilateral lower limb lower motor neuron lesion
- Parkinson's disease
- Spinal cord injury
- Traumatic brain injury
- Multiple sclerosis
- Ankle plantar flexor contraction
- Severely impaired cognition and communication
- Painful hypersensitivity to neuromuscular stimulation of common peroneal nerve
- Knee hyperextension (genu recurvatum) that cannot be adequately corrected with peroneal nerve stimulation
- History of botulinum toxin to the lower extremity within the prior three months.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2016
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00991406
Start Date
June 1 2009
End Date
November 1 2016
Last Update
August 9 2019
Active Locations (1)
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1
Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, United States, 44106