Hip exoskeleton to improve walking balance after stroke
Improving Mediolateral Walking Balance With an Assistive Exoskeleton
This trial will test whether a hip-worn exoskeleton can help people more than six months after a stroke improve their walking balance.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 21 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Medical University of South Carolina Academic / other |
| Locations | 1 site (Charleston, South Carolina) |
| Trial ID | NCT07356011 on ClinicalTrials.gov |
What this trial studies
This interventional study uses a previously developed hip exoskeleton to deliver different levels of mechanical assistance while participants walk on a treadmill. Adults with chronic stroke and lower-limb motor impairment will experience walking with no exoskeleton and with the device set to zero, low, medium, and high impedance to quantify effects on gait stabilization. Researchers will measure balance-related outcomes, gait metrics, and participant acceptance to determine whether exoskeleton assistance can improve walking balance without causing negative effects. The goal is to identify assistance strategies that are both effective and acceptable to people with stroke.
Who should consider this trial
Good fit: Ideal candidates are adults (≥21 years) at least 6 months post-stroke with measurable paretic lower-limb impairment (Fugl-Meyer LE <34), able to walk on a treadmill without a cane or walker, have gait speed ≥0.2 m/s, and report a fall in the past year or fear of falling.
Not a fit: Patients with severe cardiovascular instability, recent DVT/PE, uncontrolled comorbidities, severe visual impairment or neglect, dementia, or those unable to walk without assistive devices are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the exoskeleton could improve walking balance, lower fall risk, and increase functional mobility for people living with chronic post-stroke impairments.
How similar studies have performed: While some exoskeletons have improved post-stroke mobility, few prior devices have been designed specifically to control walking balance, so this balance-targeted approach is relatively novel with limited prior success data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Evidence of a stroke at least 6 months prior to participation * Evidence of dysfunction of the paretic lower limb (Fugl-Meyer lower extremity motor score \< 34) * At least 21 years of age * Self-reported experience of a fall in the previous year, and/or a fear of falling * Gait speed of at least 0.2 m/s * Ability to walk on a treadmill without a cane or walker * Ability to follow three step commands and communicate with experimenters to answer questions (e.g., regarding their balance confidence) * Provision of informed consent Exclusion Criteria: * Resting blood pressure higher than 220/110 mm Hg * History of unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living * Preexisting neurological orders or dementia * Legal blindness or severe visual impairment * Presence of neglect * History of DVT or pulmonary embolism within 6 months * Uncontrolled diabetes with recent weight loss, diabetic coma, or frequent insulin reactions * Orthopedic injuries or conditions (e.g., joint replacements) in the lower extremities with the potential to alter the gait pattern
Where this trial is running
Charleston, South Carolina
- Medical University of South Carolina — Charleston, South Carolina, United States (Recruiting)
Study contacts
- Study coordinator: Jesse C. Dean, PhD
- Email: deaje@musc.edu
- Phone: 8437929566
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.