Parkinson DiseaseNCT04587193
Safety and Efficacy of State-of-the-Art Exoskeleton Technology to Improve Mobility in Parkinson's Disease
A study testing Robotic-assist gait training device in people with Parkinson Disease, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
The purpose of this study is to test the safety and efficacy of using of a portable exoskeleton for walking training in persons with Parkinson's disease that have gait mobility problems and/or postural instability. Read more about this study
- Who is it for?
- Ages 21 to 95 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Robotic-assist gait training device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2020to 2 Jan 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Parkinson's Participant
- age 21 years or older,
- PD confirmed by a movement disorder specialist using UK Brain Bank Criteria,
- H\&Y stage II, III, IV, or V.
- Caregiver participant
- Caregiver of PD participant and is willing to complete questionnaire
- moderate to severe cognitive impairment / dementia (Montreal Cognitive Assessment < 17/30) except in cases where the clinician and the participants Legally Authorized Representative both determine the participant can safely complete the study
Who cannot join
- Parkinson's Participant
- neurological, musculoskeletal, or other disorders unrelated to PD contributing to impairment of gait, stance, balance or coordination,
- history of implantable cardiac device or ablative surgery,
- moderate to severe cognitive impairment / dementia (Montreal Cognitive Assessment < 17/30),
- uncontrolled orthostatic hypotension,
- feeding tube or associated port placement (PEG/J-PEG),
Show all 10Show fewer
- body height less than 5'1" or greater than 6'3" and
- body weight greater than 250 pounds.
- Caregiver participant
- 1) Unwilling to complete questionnaire
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
The purpose of this study is to test the safety and efficacy of using of a portable exoskeleton for walking training in persons with Parkinson's disease that have gait mobility problems and/or postural instability.
Read the detailed description
This is a feasibility study to examine a novel application of state-of-the-art robotic-assist gait training to improve mobility in people with Parkinson's disease (PD). The study will investigate the utility of the Keeogo® exoskeleton (a robotic-assist gait training device) for people with PD. The Keeogo® offers advantages of being lightweight and portable (for eventual home use) and is relatively quick to attach and remove. The aims here are to establish the safety of the Keeogo® for gait training in persons with PD and to preliminarily assess the potential efficacy of the Keeogo® for better balance control, gait mobility and fall reduction in persons with PD.
- Conditions
- Parkinson Disease
- Being tested
- Robotic-assist gait training device
- Keywords
- Gait, Balance, Freezing
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic-assist gait training deviceDevice
PD participants will walk while wearing a robotic-assist gait training device
| Study group | Role | What they receive |
|---|---|---|
| PD participants | Experimental | Subjects will participate in a total of 10 walking sessions, twice per week for 5 weeks, while wearing a robotic-assist gait training device. There will also be 3 additional visits for assessments at: baseline (up to 1 prior to treatment), post (1 week after last treatment), and final (4-6 weeks after last treatment). Receives: Device: Robotic-assist gait training device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of the Portable Exoskeleton
Number of "prevented" or "near falls" requiring physical assistance by the investigative training team experienced by the participant during throughout the training.
Measured: At the end of treatment (5 weeks)
Secondary outcomes (6)
Change in Walking Capacity
Walking capacity will be assessed using the 6-Minute Walking Test (6MWT) that assesses distance (in feet) walked to determine aerobic capacity and endurance. Participants will be asked to walk as far as possible in 6 minutes and the total distance will be recorded. The change in walking capacity from baseline to the week 5 treatment.
Measured: 6 weeks
Change in Freezing of Gait (FOG)
FOG will be assessed using the 6MWT. FOG will be assess using 2 gait related questions on the Unified Parkinson's Disease Rating Scale (UPDRS). Scores are summed and range from 0 (normal) to 4 (very poor).
Measured: 6 weeks
Change in Balance
The Berg Balance Scale (BBS) assesses balance via asking the participant to perform 14 functional activities. Each functional activity is rated on a 5 point scale from 0 (unable) to 4 (able safety or with minimal aid). The score on each functional activity is then added to get an overall score from 0 to 56. Scores range from 0 to 56 with higher scores indicating better balance.
Measured: 6 weeks
Change in Motor Symptoms
The Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) Part IIIMDS-UPDRS, part III will be used to assess motor symptoms and fluctuations of Parkinson Disease (PD). This outcome measure will be used to report a change in PD motor symptoms from baseline. Scores range from 0 (best score) to 56 (worst score) with higher scores indicating more symptoms.
Measured: 6 weeks
Change in Quality of Life (QOL)
Parkinson's Disease Questionnaire (PDQ39) is a 39 item self-report questionnaire assessing how often patients experience difficulties across the 8 quality of life dimensions of functioning and well-being. Items are scored from 0 (never) to 4 (always). All items are then added to get a total score. Total scores can range from 0 to 156. The lower the total score, the better quality of life.
Measured: 6 weeks
Change in Caregiver QOL
Participant's caregivers QOL will be assessed using the Parkinson's Disease Carer Questionnaire (PD-Carer), a 29 item measure of health related quality of life for use with carers of people with Parkinson's disease. Each item is scored from 0 to 4. Total scores are then added. Total scores range from 0 (no problem at all) to 116 (worst level of problem).
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start15 Jan 2020
- Primary completion22 Dec 2022
- Study completion2 Jan 2023
Why it stopped: COVID-19 prevented the study from being able to be completed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark Baron, MD, Principal investigator, Virginia Commonwealth University Health SystemRobert Hand, PT, DPT, Principal investigator, Virginia Commonwealth University Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04587193
- Sponsor's protocol ID
- HM20020066
- Status last verified
- Jan 2024
- First submitted
- 8 Oct 2020
- Last updated
- 28 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- 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 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of State-of-the-Art Exoskeleton Technology to Improve Mobility in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT04587193
- Acronym / sponsor ID
- HM20020066
- Conditions
- Parkinson Disease
- Keywords
- Gait, Balance, Freezing
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19 prevented the study from being able to be completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 15 Jan 2020 (actual)
- Primary completion
- 22 Dec 2022 (actual)
- Study completion
- 2 Jan 2023 (actual)
- First posted
- 14 Oct 2020 (actual)
- Results
- Posted 28 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test the safety and efficacy of using of a portable exoskeleton for walking training in persons with Parkinson's disease that have gait mobility problems and/or postural instability.
Detailed description
This is a feasibility study to examine a novel application of state-of-the-art robotic-assist gait training to improve mobility in people with Parkinson's disease (PD). The study will investigate the utility of the Keeogo® exoskeleton (a robotic-assist gait training device) for people with PD. The Keeogo® offers advantages of being lightweight and portable (for eventual home use) and is relatively quick to attach and remove. The aims here are to establish the safety of the Keeogo® for gait training in persons with PD and to preliminarily assess the potential efficacy of the Keeogo® for better balance control, gait mobility and fall reduction in persons with PD.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PD participants | Experimental | Device: Robotic-assist gait training deviceSubjects will participate in a total of 10 walking sessions, twice per week for 5 weeks, while wearing a robotic-assist gait training device. There will also be 3 additional visits for assessments at: baseline (up to 1 prior to treatment), post (1 week after last treatment), and final (4-6 weeks after last treatment). |
Who may qualify
- Ages
- 21 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Parkinson's Participant
- age 21 years or older,
- PD confirmed by a movement disorder specialist using UK Brain Bank Criteria,
- H\&Y stage II, III, IV, or V.
- Caregiver participant
Key exclusion criteria (10 listed)
- Parkinson's Participant
- neurological, musculoskeletal, or other disorders unrelated to PD contributing to impairment of gait, stance, balance or coordination,
- history of implantable cardiac device or ablative surgery,
- moderate to severe cognitive impairment / dementia (Montreal Cognitive Assessment < 17/30),
- uncontrolled orthostatic hypotension,
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 |
|---|---|---|
| Robotic-assist gait training devicePD participants will walk while wearing a robotic-assist gait training device | Device | PD participants |
Primary outcome
Safety of the Portable Exoskeleton
Time frame: At the end of treatment (5 weeks)
Number of "prevented" or "near falls" requiring physical assistance by the investigative training team experienced by the participant during throughout the training.
6 secondary outcomes
Change in Walking Capacity
Time frame: 6 weeks
Change in Freezing of Gait (FOG)
Time frame: 6 weeks
Change in Balance
Time frame: 6 weeks
Change in Motor Symptoms
Time frame: 6 weeks
Change in Quality of Life (QOL)
Time frame: 6 weeks
Change in Caregiver QOL
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Mark Baron, MD principal investigator
Virginia Commonwealth University Health System
Robert Hand, PT, DPT principal investigator
Virginia Commonwealth University Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic-assist gait training device in people with Parkinson Disease, run by Virginia Commonwealth University 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 7 inclusion and 10 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: stopped early, as of the sponsor's last update on 28 Feb 2024. 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?
Yes. Results are posted in the registry (first posted 28 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Safety of the Portable Exoskeleton (time frame: At the end of treatment (5 weeks)). 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 28 Feb 2024.