Electrical Stimulation for Recovery of Ankle Dorsiflexion in Chronic Stroke Survivors

Completed

Phase 1 Results N/A

Update History

15 Dec '11
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 21 to 80 years - >6 months from a first clinical non-hemorrhagic or hemorrhagic stroke - Medically stable - Unilateral lower extremity hemiparesis - Ankle dorsiflexor strength of ≤4/5 on the MRC scale, while seated - Able to ambulate 16 feet (5 meters) continuously with minimal assistance or less, without the use of an AFO. - AFO is clinically indicated (footdrop during ambulation or inefficient gait patterns) - NMES of the paretic ankle dorsiflexors produces ankle dorsiflexion to neutral without pain. - Full voluntary dorsiflexion of the contralateral ankle - Skin intact on hemiparetic lower extremity - Able to don the NMES system or caregiver available to assist with device if needed. - Able to hear and respond to stimulator auditory cues - Able to follow 3-stage commands - Able to recall 2 of 3 items after 30 minutes Exclusion Criteria: - Brainstem stroke - Severely impaired cognition and communication - History of peroneal nerve injury - History of Parkinson's, SCI, TBI, or multiple sclerosis - Uncontrolled seizure disorder - Uncompensated hemi-neglect (extinguishing to double simultaneous stimulation) - Edema of the affected lower extremity - Absent sensation of lower leg and foot - Evidence of deep venous thrombosis or thromboembolism - History of cardiac arrhythmias with hemodynamic instability - Cardiac pacemaker or other implanted electronic system - Botulinum toxin injections to any lower extremity muscle in the last 3 months - Pregnancy - Currently receiving Physical Therapy for the lower extremity
Old
Inclusion Criteria: - Age 21 to 80 years - >6 months from a first clinical non-hemorrhagic or hemorrhagic stroke - Medically stable - Unilateral lower extremity hemiparesis - Ankle dorsiflexor strength of ?4/5 on the MRC scale, while seated - Able to ambulate 16 feet (5 meters) continuously with minimal assistance or less, without the use of an AFO. - AFO is clinically indicated (footdrop during ambulation or inefficient gait patterns) - NMES of the paretic ankle dorsiflexors produces ankle dorsiflexion to neutral without pain. - Full voluntary dorsiflexion of the contralateral ankle - Skin intact on hemiparetic lower extremity - Able to don the NMES system or caregiver available to assist with device if needed. - Able to hear and respond to stimulator auditory cues - Able to follow 3-stage commands - Able to recall 2 of 3 items after 30 minutes Exclusion Criteria: - Brainstem stroke - Severely impaired cognition and communication - History of peroneal nerve injury - History of Parkinson's, SCI, TBI, or multiple sclerosis - Uncontrolled seizure disorder - Uncompensated hemi-neglect (extinguishing to double simultaneous stimulation) - Edema of the affected lower extremity - Absent sensation of lower leg and foot - Evidence of deep venous thrombosis or thromboembolism - History of cardiac arrhythmias with hemodynamic instability - Cardiac pacemaker or other implanted electronic system - Botulinum toxin injections to any lower extremity muscle in the last 3 months - Pregnancy - Currently receiving Physical Therapy for the lower extremity