Feasibility and Safety of a Portable Exoskeleton to Improve Mobility in Parkinson's Disease

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Physical therapy approaches for balance and walking deficits in Parkinson's disease (PD) have limited effectiveness, with mostly short-lasting benefits. An exoskeleton is a device that straps to the legs and provides a passive force to assist people to better ambulate. The goal of this study is to establish the feasibility and safety of a lightweight exoskeleton on mobility and fall reduction in people with PD. As most PD patients eventually require assistive mobility devices, the exoskeleton represents a new option for increased, mobility, quality of life, and independence. Qualified subjects will come to the clinic twice weekly for six weeks (12 total visits) and wear the exoskeleton device while walking under the supervision of a trained physical therapist. Study staff will also interview participants and assess their PD symptoms, quality of life, and overall mobility. This study hopes to establish exoskeletons as modern, standard of care devices, which allow people with PD to maintain more independent and productive lives.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:

• PD confirmed by a PADRECC movement disorder specialist using UK Brain Bank Criteria

• Modified H\&Y stage II-V

Locations
United States
Virginia
Hunter Holmes McGuire VA Medical Center, Richmond, VA
RECRUITING
Richmond
Contact Information
Primary
Rachel Sinclair, MPHA
rachel.sinclair@va.gov
(804) 675-5931
Backup
Mark S Baron, MD
mark.baron@va.gov
(804) 675-6700
Time Frame
Start Date: 2024-09-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 30
Treatments
Other: Feasibility and Safety
This is a feasibility study to assess the safety and potential utility of a lightweight ground exoskeleton (Keeogo, B-Temia, Inc.) to enhance mobility in people with Parkinson's disease (PD).
Related Therapeutic Areas
Sponsors
Leads: VA Office of Research and Development

This content was sourced from clinicaltrials.gov