Implant for Walking After Stroke
Stroke, Hemiplegia, Gait, Hemiplegic
About this trial
This is an interventional device feasibility trial for Stroke
Eligibility Criteria
Inclusion Criteria: At least 6-months post stroke Age 21 to 75 years old Able to ambulate, but does not require the assistance of more than one person Walk slower than 0.8m/s during a 10m walk test Lower extremity Fugl-Meyer Motor Assessment (FMA) <= 20 Reduced peak hip, knee and/or ankle range of motion during stance or swing phases Modified Ashworth Scale (MAS) <= 2 at the above joints during passive flexion and extension Innervated and excitable lower extremity and trunk musculature Appropriate body habitus (height and weight within acceptable limits as determined by study physician) Adequate social support and stability Willingness to comply with follow-up procedures Neurologically stable as determined by a physician Exclusion Criteria: Non-English speaking Significant range of motion limitations (lacking hip extension, etc.) History of spontaneous fractures or other evidence of excessively low bone density Acute orthopedic problems (severe scoliosis, joint dislocations, etc.) Medical complications (cardiac abnormalities, skin breakdowns, uncontrolled seizures, immunological/pulmonary/renal/circulatory compromise, additional neurologic conditions etc.) Cardiovascular or pulmonary disease Uncontrolled diabetes or hypertension Presence of a demand pacemaker or cardiac defibrillator Pregnancy Complications of stroke that result in an increased risk of falls (apraxia, uncompensated hemineglect, hemianopsia etc.) Significant history of repeated falls Severely impaired cognition and communication Any other medical or psychological condition that would be a contraindication
Sites / Locations
- Louis Stokes Cleveland Veterans Affairs Medical CenterRecruiting
- MetroHealth Medical Center
Arms of the Study
Arm 1
Experimental
Implantation, controller development, and evaluation
This phase includes installing the device and setting the individual up for home use, creating advanced controllers for walking and evaluating the effect of the device over several months.