Parkinson's DiseaseNCT06028529
Feasibility and Safety of a Portable Exoskeleton to Improve Mobility in Parkinson's Disease
A study testing Exoskeleton in people with Parkinson's Disease, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Exoskeleton
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2024to 25 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Parkinson's disease (PD) confirmed by a Parkinson's Disease Research, Education and Clinical Center (PADRECC) movement disorder specialist using UK Brain Bank Criteria
- Modified Hoehn and Yahr (H\&Y) stage II-V
- Veteran
- Able to attend visits at the Richmond VA Medical Center
Who cannot join
- Neurological, musculoskeletal, or other disorders unrelated to PD contributing to impairment of stance, gait, balance or coordination
- Severe congestive heart failure (CHF), chronic obstructive pulmonary disease (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)
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Richmond VA Medical Center, Richmond, VA
Richmond, Virginia, 23249-0001
About this study
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.
Read the 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 with PD; however, the effectiveness of these therapies is limited. This study proposes to investigate the utility of a portable exoskeleton for people with PD. The goal is to establish the safety of a lightweight portable exoskeleton, the Keeogo, for gait training and to preliminarily assess its potential efficacy for gait mobility and fall reduction. As the vast majority of PD patients eventually require assistive mobility devices, portable exoskeletons represents an avenue for increased, mobility, quality of life, and independence. Robotic-assist gait training (RAGT) has been extensively applied as a remarkable therapeutic modality, such that it is enabling highly motivated people with devastating neurologic injuries to regain independent ambulation. Despite the potential for this technology to transform the lives of people with PD, these devices are not being adequately investigated in people with movement disorders.
To establish preliminary safety and efficiency of the Keeogo exoskeleton for PD patients at various disease stages, the investigators will examine representative subjects in Hohen \& Yahr stages II, III, and IV. Inclusion criteria are: 1) PD confirmed by a PADRECC movement disorder specialist using UK Brain Bank Criteria, 2) Modified H\&Y stage II-V. Exclusion criteria are: 1) neurological, musculoskeletal, or other disorders unrelated to PD contributing to impairment of stance, gait, balance or coordination, 2) severe CHF, COPD, or those requiring nasal canula O2, 3) history of implantable cardiac device or ablative surgery, 4) moderate to severe cognitive impairment / dementia (Montreal Cognitive Assessment < 17/30), 5) symptomatic orthostatic hypotension with exertion, 6) feeding tube or associated port placement (PEG/J-PEG), 7) body height less than 5'1" or greater than 6'3" 8) body weight greater than 250 pounds, and 9) amputation of any portion of the lower limbs. Subjects will participate in a total of 30 minutes RAGT ambulation with the Keeogo twice per week for 8 weeks (16 sessions). Subjects may opt to utilize a platform rolling walker, rolling walker, bilateral Lofstrand crutches or a unilateral device, such as a cane or Lofstrand crutch, and will be maintained throughout the intervention.
To establish safety, the number and severity of AEs, such as falls, discomfort, skin or musculoskeletal injury, and orthostatic hypotensive episodes will be documented. Intervention efficacy will be measured pre- and post-donning of the Keeogo exoskeleton at bi-weekly intervention visits, and at 3 post-study visits. Walking capacity, including benefits on FoG, will be assessed with the Six Minute Walk Test (6MWT), balance and postural stability with the MiniBest test, and disease severity with the Examination, Part III, of the Unified Parkinson's Disease Rating Scale (UPDRS). Additional assessments will include surveys about quality of life, activity, balance, and feedback on the device. As a primary end point for establishing efficacy, the 6MWT will be compared between end of training and baseline (with and without the exoskeleton), as well as at 6 and 12 weeks post-study as a durability assessment towards establishing a need for future assessment of in-home usage. These pilot investigations are expected to lay the groundwork for a large multi-center clinical study to establish ground exoskeletons as modern, standard of care devices to aid Veterans and other people with PD and other disabling movement disorders to maintain a more normal and productive life.
- Conditions
- Parkinson's Disease
- Being tested
- Exoskeleton
- Keywords
- exoskeleton
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExoskeletonDevice
Also called Keeogo
lightweight ground exoskeleton
| Study group | Role | What they receive |
|---|---|---|
| Feasibility and Safety | Other | 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). Receives: Device: Exoskeleton |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Falls While Wearing the Exoskeleton (Safety and Tolerability) Change
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.
Measured: Through last training visit (weeks 1-8, 16 sessions)
Incidence of Attrition (Tolerability) Change
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.
Measured: Through last training visit (weeks 1-8, 16 sessions)
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) Change
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.
Measured: through last training visit (weeks 1-8, 16 sessions)
Six-minute Walk Test (Suitability as a Future Primary Efficacy Measure) Change
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.
Measured: through last training visit (weeks 1-8, 16 sessions) and 6- and 12-wks post-training
Patient Satisfaction
All subjects will be interviewed for patient satisfaction with wearing and training with the exoskeleton.
Measured: immediate post-training
Secondary outcomes (2)
Motor examination (Part III) of the modified Unified Parkinson's Disease Rating Scale (Suitability as a Future Secondary Efficacy Measure)
Will assess the suitability of the modified UPDRS Part III (nl = 0, max. 128) as a future secondary clinical outcome measure. Will be collected at baseline and end of training. Additionally, 6- and 12-weeks post-training assessments will be used to preliminarily assess the durability of training effects.
Measured: immediate post-training, 6- and 12-wks post-training
Mini Best Test (Suitability as a Future Secondary Efficacy Measure)
Will assess suitability as a future secondary clinical outcome measure, focused on balance. Additionally, 6- and 12-weeks post-training assessments will be used to preliminarily assess the durability of training effects.
Measured: immediate post-training, 6- and 12-wks post-training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2023
- Study start1 Sep 2024
- Primary completion25 Feb 2026
- Study completion25 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Safety, tolerability, feasibility, methodological assessment, and sample characteristics with consideration of multiple staging and high patient variability towards the design of a future clinical efficacy study.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Jessica B Lehosit, Principal investigator, Richmond VA Medical Center, Richmond, VA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06028529
- Sponsor's protocol ID
- N4387-P
- Other IDs
- 5I21RX004387
- Status last verified
- Sep 2026
- First submitted
- 30 May 2023
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Safety of a Portable Exoskeleton to Improve Mobility in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06028529
- Acronym / sponsor ID
- N4387-P
- Conditions
- Parkinson's Disease
- Keywords
- exoskeleton
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 25 Feb 2026 (actual)
- Study completion
- 25 Feb 2026 (actual)
- First posted
- 8 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 with PD; however, the effectiveness of these therapies is limited. This study proposes to investigate the utility of a portable exoskeleton for people with PD. The goal is to establish the safety of a lightweight portable exoskeleton, the Keeogo, for gait training and to preliminarily assess its potential efficacy for gait mobility and fall reduction. As the vast majority of PD patients eventually require assistive mobility devices, portable exoskeletons represents an avenue for increased, mobility, quality of life, and independence. Robotic-assist gait training (RAGT) has been extensively applied as a remarkable therapeutic modality, such that it is enabling highly motivated people with devastating neurologic injuries to regain independent ambulation. Despite the potential for this technology to transform the lives of people with PD, these devices are not being adequately investigated in people with movement disorders.
To establish preliminary safety and efficiency of the Keeogo exoskeleton for PD patients at various disease stages, the investigators will examine representative subjects in Hohen \& Yahr stages II, III, and IV. Inclusion criteria are: 1) PD confirmed by a PADRECC movement disorder specialist using UK Brain Bank Criteria, 2) Modified H\&Y stage II-V. Exclusion criteria are: 1) neurological, musculoskeletal, or other disorders unrelated to PD contributing to impairment of stance, gait, balance or coordination, 2) severe CHF, COPD, or those requiring nasal canula O2, 3) history of implantable cardiac device or ablative surgery, 4) moderate to severe cognitive impairment / dementia (Montreal Cognitive Assessment < 17/30), 5) symptomatic orthostatic hypotension with exertion, 6) feeding tube or associated port placement (PEG/J-PEG), 7) body height less than 5'1" or greater than 6'3" 8) body weight greater than 250 pounds, and 9) amputation of any portion of the lower limbs. Subjects will participate in a total of 30 minutes RAGT ambulation with the Keeogo twice per week for 8 weeks (16 sessions). Subjects may opt to utilize a platform rolling walker, rolling walker, bilateral Lofstrand crutches or a unilateral device, such as a cane or Lofstrand crutch, and will be maintained throughout the intervention.
To establish safety, the number and severity of AEs, such as falls, discomfort, skin or musculoskeletal injury, and orthostatic hypotensive episodes will be documented. Intervention efficacy will be measured pre- and post-donning of the Keeogo exoskeleton at bi-weekly intervention visits, and at 3 post-study visits. Walking capacity, including benefits on FoG, will be assessed with the Six Minute Walk Test (6MWT), balance and postural stability with the MiniBest test, and disease severity with the Examination, Part III, of the Unified Parkinson's Disease Rating Scale (UPDRS). Additional assessments will include surveys about quality of life, activity, balance, and feedback on the device. As a primary end point for establishing efficacy, the 6MWT will be compared between end of training and baseline (with and without the exoskeleton), as well as at 6 and 12 weeks post-study as a durability assessment towards establishing a need for future assessment of in-home usage. These pilot investigations are expected to lay the groundwork for a large multi-center clinical study to establish ground exoskeletons as modern, standard of care devices to aid Veterans and other people with PD and other disabling movement disorders to maintain a more normal and productive life.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Safety, tolerability, feasibility, methodological assessment, and sample characteristics with consideration of multiple staging and high patient variability towards the design of a future clinical efficacy study.
| Arm | Type | Receives |
|---|---|---|
| Feasibility and Safety | Other | Device: ExoskeletonThis 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). |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Parkinson's disease (PD) confirmed by a Parkinson's Disease Research, Education and Clinical Center (PADRECC) movement disorder specialist using UK Brain Bank Criteria
- Modified Hoehn and Yahr (H\&Y) stage II-V
- Veteran
- Able to attend visits at the Richmond VA Medical Center
Key exclusion criteria (12 listed)
- Neurological, musculoskeletal, or other disorders unrelated to PD contributing to impairment of stance, gait, balance or coordination
- Severe congestive heart failure (CHF), chronic obstructive pulmonary disease (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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExoskeletonAlso: Keeogolightweight ground exoskeleton | Device | Feasibility and Safety |
Primary outcome
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.
2 secondary outcomes
Motor examination (Part III) of the modified Unified Parkinson's Disease Rating Scale (Suitability as a Future Secondary Efficacy Measure)
Time frame: immediate post-training, 6- and 12-wks post-training
Mini Best Test (Suitability as a Future Secondary Efficacy Measure)
Time frame: immediate post-training, 6- and 12-wks post-training
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica B Lehosit principal investigator
Richmond VA Medical Center, Richmond, VA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exoskeleton in people with Parkinson's Disease, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.