Device to improve walking in stroke survivors
Customizable Cooperative Multi-joint Control to Enhance Walking Mobility After Stroke
This study is testing a special device that gets implanted in stroke survivors to see if it can help them walk better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 6 (estimated) |
| Ages | 21 Years to 75 Years |
| Sex | All |
| Sponsor | MetroHealth Medical Center Academic / other |
| Locations | 2 sites (Cleveland, Ohio and 1 other locations) |
| Trial ID | NCT05740540 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effects of an implanted neural stimulator designed to enhance walking ability in individuals who have experienced a stroke. Participants will undergo a surgical procedure to implant the device, which delivers electrical pulses to stimulate muscles involved in walking. The study consists of two phases: screening to determine eligibility and implantation followed by training and evaluation of the device's effectiveness over several months. The system also incorporates advanced controllers that adapt to the user's movements based on external sensors.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 21 to 75 who are at least six months post-stroke and can walk with minimal assistance.
Not a fit: Patients with significant range of motion limitations or acute orthopedic problems may not benefit from this study.
Why it matters
Potential benefit: If successful, this device could significantly improve mobility and quality of life for stroke survivors.
How similar studies have performed: Other studies have shown promise with similar neural stimulation approaches, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Cleveland, Ohio and 1 other locations
- Louis Stokes Cleveland Veterans Affairs Medical Center — Cleveland, Ohio, United States (Recruiting)
- MetroHealth Medical Center — Cleveland, Ohio, United States (Not_yet_recruiting)
Study contacts
- Principal investigator: Nathan Makowski, PhD — MetroHealth System, Ohio
- Study coordinator: Lisa Lombardo, MPT
- Email: lisa.lombardo2@va.gov
- Phone: 216-791-3800
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.