Actively Recruiting
Implant for Walking After Stroke
Led by MetroHealth Medical Center · Updated on 2025-09-29
6
Participants Needed
2
Research Sites
215 weeks
Total Duration
On this page
Sponsors
M
MetroHealth Medical Center
Lead Sponsor
C
Case Western Reserve University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Implant for Walking After Stroke
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 6 months post stroke
- Age 21 to 75 years old
- Able to ambulate without assistance from more than one person
- Walk slower than 0.8 meters per second during a 10-meter walk test
- Lower extremity Fugl-Meyer Motor Assessment score of 20 or less
- Reduced peak hip, knee, and/or ankle range of motion during stance or swing phases
- Modified Ashworth Scale score of 2 or less at hip, knee, or ankle during passive flexion and extension
- Innervated and excitable lower extremity and trunk muscles
- Appropriate height and weight as determined by study physician
- Adequate social support and stability
- Willingness to comply with follow-up procedures
- Neurologically stable as determined by a physician
You will not qualify if you...
- Non-English speaking
- Significant limitations in range of motion such as lacking hip extension
- History of spontaneous fractures or very low bone density
- Acute orthopedic problems like severe scoliosis or joint dislocations
- Medical complications including cardiac abnormalities, skin breakdowns, uncontrolled seizures, or immunological, pulmonary, renal, circulatory issues
- Cardiovascular or pulmonary disease
- Uncontrolled diabetes or hypertension
- Presence of a demand pacemaker or cardiac defibrillator
- Pregnancy
- Stroke complications increasing fall risk such as apraxia, uncompensated hemineglect, or hemianopsia
- Significant history of repeated falls
- Severe cognitive or communication impairments
- Any other medical or psychological condition that contraindicates participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Louis Stokes Cleveland Veterans Affairs Medical Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
2
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
Not Yet Recruiting
Research Team
L
Lisa Lombardo, MPT
CONTACT
N
Nathan Makowski
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
1
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