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Exoskeleton for Parkinson's Disease Mobility

This study is looking at a lightweight device called an exoskeleton, which straps to your legs, to see if it can help people with Parkinson's disease (PD) move better and reduce falls. Current physical therapies for walking and balance in PD often have limited, short-term benefits. This study wants to find out if the exoskeleton is safe and practical to use. You might be able to join if you are a veteran between 18 and 90 years old, have confirmed Parkinson's disease, and can come to the Richmond VA Medical Center for visits. The study will measure how often falls happen, if people stop participating, and any side effects while using the exoskeleton. The current status of this study is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 30 participants.
What's involved
Qualified participants will come to the clinic twice a week for eight weeks, for a total of 16 visits. During these visits, you will wear the exoskeleton device while walking under supervision.
Compensation
Not stated in the trial record.
Follow-up
The primary safety and tolerability measures will be tracked through the last training visit, which is at weeks 1-8 (16 sessions).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06028529

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

Recruiting
NAAges 18–90InterventionalDevice feasibility
VA Office of Research and Development
~30 participants
Updated 2025-11-21 on ClinicalTrials.gov
What's tested:Exoskeleton

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Falls While Wearing the Exoskeleton (Safety and Tolerability) Change
Measured over Through last training visit (weeks 1-8, 16 sessions)
+4 more outcomes measured

Conditions

Parkinson's Disease

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Parkinson Disease

NCT06028529

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Richmond VA Medical Center, Richmond, VA

    Richmond, Virginiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Jessica B Lehosit · PRINCIPAL_INVESTIGATOR · Richmond VA Medical Center, Richmond, VA

Who to contact

Rachel G Sinclair, MPHA
[email protected]
(804) 675-5931
Email the study team

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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

What this trial measures

  • Incidence of Falls While Wearing the Exoskeleton (Safety and Tolerability) ChangeThrough last training visit (weeks 1-8, 16 sessions)

    Patients will be continuously supervised by a trained physical therapist and the expectation is that there will be no falls while wearing the device. All primary safety and tolerability measures will be separately assessed with consideration of H\&Y staging (2-4; max. 5) and cognition (based on MOCA scores 0 = nl, max. 30). -Minimal attrition rate based on subjects being unable to complete the protocol. This could for example establish that the Keeogo device is not tolerated by more advanced (H\&Y Stage 5) patients, but is acceptable for others.

  • Incidence of Attrition (Tolerability) ChangeThrough last training visit (weeks 1-8, 16 sessions)

    The expectation is that there will be minimal attrition rate based on subjects being unable to complete the protocol. In the case of attrition, patients will be interviewed for contributory sources.

  • Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) Changethrough last training visit (weeks 1-8, 16 sessions)

    Patients will be questioned at the beginning of each session about potential AEs and any AEs observed during sessions by the therapists will be recorded at each training session. The expectation is that there will be no uncorrected and unacceptable AEs as captured by regular structured interviews.

  • Six-minute Walk Test (Suitability as a Future Primary Efficacy Measure) Changethrough last training visit (weeks 1-8, 16 sessions) and 6- and 12-wks post-training

    The suitability of the 6MWT as a future primary clinical outcome measure (and our secondary measures) will be determined from the therapists' impression of ease and reliability of usage and from anticipated trends in scoring improvement. The outcomes here from the 6MWT and secondary measures will be further used towards powering for a future clinical efficacy study, while accounting for preliminary defined influences of severity of PD (H\&Y Staging) and cognition (MOCA scoring). Additionally, 6- and 12-weeks post-training assessments will be used to preliminarily assess the durability of training effects.

  • Patient Satisfactionimmediate post-training

    All subjects will be interviewed for patient satisfaction with wearing and training with the exoskeleton.