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

Recruiting now · Not applicable

Conditions studied: Parkinson's Disease

In brief

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 facts

Study ID: NCT06028529
Run by: VA Office of Research and Development
People needed: 30
Starts: 2024-09-01
Expected to finish: 2026-12-31
Last updated by the study team: 2025-11-21

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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 it is running

Richmond VA Medical Center, Richmond, VA — Richmond, Virginia, United States (enrolling)

Full record on ClinicalTrials.gov

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