NCT06028529 · VA Office of Research and Development
Feasibility and Safety of a Portable Exoskeleton to Improve Mobility in Parkinson's Disease
What this study 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.
View original scientific description
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.
Interventions
DEVICE
Exoskeleton
lightweight ground exoskeleton
Primary outcome measures
Incidence of Falls While Wearing the Exoskeleton (Safety and Tolerability) Change
Time frame: Through 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) Change
Time frame: Through 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) Change
Time frame: through 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) Change
Time frame: through 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 Satisfaction
Time frame: immediate post-training
All subjects will be interviewed for patient satisfaction with wearing and training with the exoskeleton.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- PD confirmed by a PADRECC movement disorder specialist using UK Brain Bank Criteria
- Modified H\&Y stage II-V
- 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
Where
- Richmond, Virginia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 21, 2025 · Source of record for eligibility and locations