Recruiting

Exoskeleton

Sponsor:

VA Office of Research and Development

Code:

NCT06028529

Conditions

Parkinson's Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Exoskeleton

Study Details

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 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

Parkinson's Disease

Study ID

NCT06028529

Start date

Sep 1, 2024

Status verified date

Nov, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Aug 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

other: Feasibility and Safety

This is a feasibility study to assess the safety and potential utility of a lightweight ground exoskeleton (Keeogo, B-Temia, Inc.) to enhance mobility in people with Parkinson's disease (PD).

Interventions

Exoskeleton

lightweight ground exoskeleton

Primary outcome measure

  • Incidence of Falls While Wearing the Exoskeleton (Safety and Tolerability) Change [ Time Frame: Through last training visit (weeks 1-8, 16 sessions) ]
  • Incidence of Attrition (Tolerability) Change [ Time Frame: Through last training visit (weeks 1-8, 16 sessions) ]
  • Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) Change [ Time Frame: through last training visit (weeks 1-8, 16 sessions) ]
  • Six-minute Walk Test (Suitability as a Future Primary Efficacy Measure) Change [ Time Frame: through last training visit (weeks 1-8, 16 sessions) and 6- and 12-wks post-training ]
  • Patient Satisfaction [ Time Frame: immediate post-training ]

Central Contacts and Locations

Central contacts

Locations

Richmond VA Medical Center, Richmond, VA

Recruiting

Richmond, Virginia, United States, 23249-0001

Contacts

Principal Investigator:

Jessica B Lehosit

More Information

Sponsor

VA Office of Research and Development

Last update posted

Nov 21, 2025

Last verified

Nov, 2025

Keywords

  • exoskeleton

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2025-11-21.