Status:
RECRUITING
Feasibility and Safety of a Portable Exoskeleton to Improve Mobility in Parkinson's Disease
Lead Sponsor:
VA Office of Research and Development
Conditions:
Parkinson's Disease
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief 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 l...
Detailed Description
Currently, progressive resistance exercise training, high intensity treadmill training, balanced-based perturbation, and standard physical exercises are utilized to treat mobility deficits associated ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06028529
Start Date
September 1 2024
End Date
December 31 2026
Last Update
November 21 2025
Active Locations (1)
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1
Richmond VA Medical Center, Richmond, VA
Richmond, Virginia, United States, 23249-0001