Using a portable exoskeleton to help people with Parkinson's disease walk better
Feasibility and Safety of a Portable Exoskeleton to Improve Mobility in Parkinson's Disease
This study is testing a lightweight exoskeleton to see if it can help people with Parkinson's disease walk better and feel more independent.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (Richmond, Virginia) |
| Trial ID | NCT06028529 on ClinicalTrials.gov |
What this trial studies
This study investigates the feasibility and safety of a lightweight exoskeleton designed to assist individuals with Parkinson's disease in improving their mobility and reducing falls. Participants will attend the clinic twice a week for six weeks, where they will wear the exoskeleton while walking under the supervision of a trained physical therapist. The study aims to assess the device's impact on gait mobility, quality of life, and overall PD symptoms. By exploring this innovative approach, the researchers hope to establish exoskeletons as a standard care option for enhancing independence in patients with Parkinson's disease.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with Parkinson's disease who are in Hohen & Yahr stages II to V.
Not a fit: Patients with severe cognitive impairment, other neurological disorders, or significant musculoskeletal issues unrelated to Parkinson's disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new assistive device that significantly improves mobility and quality of life for patients with Parkinson's disease.
How similar studies have performed: While robotic-assist gait training has shown promise in other neurological conditions, the specific application of portable exoskeletons for Parkinson's disease is still being explored and is considered novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * PD confirmed by a PADRECC movement disorder specialist using UK Brain Bank Criteria * Modified H\&Y stage II-V * Veteran * Able to attend visits at the Richmond VA Medical Center Exclusion Criteria: * neurological, musculoskeletal, or other disorders unrelated to PD contributing to impairment of stance, gait, balance or coordination * severe CHF, COPD, or those requiring nasal canula O2 * history of implantable cardiac device or ablative surgery * moderately-severe to severe cognitive impairment / dementia (Montreal Cognitive Assessment \< 17/30) * symptomatic orthostatic hypotension with exertion * feeding tube or associated port placement (PEG/J-PEG) * body height less than 5'1" or greater than 6'3" * body weight greater than 250 pounds * amputation of any portion of the lower limbs * osteoporosis as defined by DEXA Scan T score \< -2.5 * failure to meet B-Temia-established hip and knee flexion and extension manual muscle test (MMT) prerequisite screening parameters, which assure that individuals can adequately engage and walk against the resistive forces of the Keeogo * inability to complete 20 minutes of walking with the exoskeleton (over a maximum period of one hour) at the initial screening/testing session
Where this trial is running
Richmond, Virginia
- Richmond VA Medical Center, Richmond, VA — Richmond, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Jessica B Lehosit — Richmond VA Medical Center, Richmond, VA
- Study coordinator: Rachel G Sinclair, MPHA
- Email: rachel.sinclair@va.gov
- Phone: (804) 675-5931
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.