Stroke Clinical Trial
Official title:
Customizable Cooperative Multi-joint Control to Enhance Walking Mobility After Stroke
This is a device study that will evaluate the effect of an implanted stimulator on improving walking in stroke survivors. There are two phases in the study: 1) Screening - this phase determines if the individual is a good candidate to receive an implanted system, 2) 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.
Status | Recruiting |
Enrollment | 6 |
Est. completion date | March 31, 2027 |
Est. primary completion date | March 31, 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 75 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Louis Stokes Cleveland Veterans Affairs Medical Center | Cleveland | Ohio |
United States | MetroHealth Medical Center | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
MetroHealth Medical Center | Case Western Reserve University, Cleveland State University, Louis Stokes VA Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Difference in Gait speed | The 10mWT is used to assess walking speed in meters/second (m/s) over a short distance.
Gait speed is how we're evaluating whether the advanced controller works better than a simple generic triggering approach. |
baseline, ~18 weeks post implant, ~44 week post implant | |
Secondary | Difference in Usability Rating Scale (URS) | participants will rate the task on a seven-point scale from "very easy" (3) to "very difficult" (-3). Difficulty will be assessed after the 10 m walk test | baseline, ~18 weeks post implant, ~44-week post implant |
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