Feasibility and Safety of a Portable Exoskeleton to Improve Mobility in Parkinson's Disease
Recruiting
N/AInterventional Study
Parkinson's Disease
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 90
Sex
Any
Study type
Interventional
Purpose
Device Feasibility
Participants needed
30 (estimated)
Sponsor
VA Office of Research and Development · Federal
Who this trial is looking for
This trial is looking for veterans with Parkinson's Disease to test a new lightweight exoskeleton that may help improve walking and mobility. Participants will attend the clinic twice a week for eight weeks to use the device while being supervised and assessed by staff.
Are You a Good Fit for This Trial?
Rules you outOsteoporosisLower limb amputation
You may be able to join if
I have been diagnosed with Parkinson's Disease.
I am a veteran.
I can attend visits at the Richmond VA Medical Center.
I am between Modified H&Y stage II and V.
You may not be able to join if
I have other neurological or musculoskeletal disorders affecting my movement.
I have severe heart failure or chronic obstructive pulmonary disease.
I have a history of heart surgery or devices implanted.
I have severe cognitive impairment or dementia.
I have low blood pressure that causes symptoms with exertion.
I have a feeding tube.
I am shorter than 5'1" or taller than 6'3".
I weigh more than 250 pounds.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 p…
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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 Criteria:
* neurological, musculoskeletal, or other disorders unrelated to PD contribu…
Inclusion Criteria:
* 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 Criteria:
* 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
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