Actively Recruiting

Phase Not Applicable
Age: 18Years - 90Years
All Genders
NCT06028529

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

Led by VA Office of Research and Development · Updated on 2025-11-21

30

Participants Needed

1

Research Sites

121 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Parkinson's Disease confirmed by a PADRECC movement disorder specialist using UK Brain Bank Criteria
  • Modified Hohen & Yahr stage II to V
  • Veteran status
  • Able to attend visits at the Richmond VA Medical Center
Not Eligible

You will not qualify if you...

  • Neurological, musculoskeletal, or other disorders unrelated to Parkinson's disease that affect stance, gait, balance, or coordination
  • Severe congestive heart failure, chronic obstructive pulmonary disease, or need for nasal cannula oxygen
  • History of implantable cardiac device or ablative surgery
  • Moderate to severe cognitive impairment or dementia (Montreal Cognitive Assessment score less than 17/30)
  • Symptomatic orthostatic hypotension with exertion
  • Feeding tube or associated port placement (PEG/J-PEG)
  • Height less than 5 feet 1 inch or greater than 6 feet 3 inches
  • Weight greater than 250 pounds
  • Amputation of any part of the lower limbs
  • Osteoporosis with DEXA Scan T score less than -2.5
  • Failure to meet hip and knee muscle strength requirements needed to use the Keeogo exoskeleton
  • Inability to walk for 20 minutes with the exoskeleton during initial screening/testing session

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Richmond VA Medical Center, Richmond, VA

Richmond, Virginia, United States, 23249-0001

Actively Recruiting

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Research Team

R

Rachel G Sinclair, MPHA

CONTACT

J

Jessica B Lehosit

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DEVICE_FEASIBILITY

Number of Arms

1

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