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

Part of paid clinical trials in Richmond, Virginia.

Sponsor
VA Office of Research and Development
Study ID
NCT06028529
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Exoskeleton — DEVICE
    lightweight ground exoskeleton

Study Details

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 eight weeks (16 total visits) and wear the exoskeleton device while walking under the supervision of a trained kinesiotherapist. 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.

Key Dates

Start date
Sep 1, 2024
Status verified
Nov 2025
Primary completion
Aug 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY

Arms

  • 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).

Primary Outcome Measure

Incidence of Falls While Wearing the Exoskeleton (Safety and Tolerability) Change [ Time Frame: Through last training visit (weeks 1-8, 16 sessions) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Richmond VA Medical Center, Richmond, VARichmondVirginia23249-0001
Amanda O Hill
[email protected]
804-675-5151
Alyssa Huizar
[email protected]
(804) 675-5151
Jessica B Lehosit (PRINCIPAL_INVESTIGATOR)

Find similar trials in Richmond, VA

By condition
Parkinson's disease
By specialty
NeurologyBrain disorders
By research site
Richmond VA Medical Center, Richmond, VA· Richmond, VA

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