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Parkinson DiseaseNCT03583879

Using Gait Robotics to Improve Symptoms of Parkinson's Disease

A study testing Exoskeleton exercise, Standard exercise and No treatment in people with Parkinson Disease and Dementia, run by University of New Brunswick at 2 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study evaluates the benefits of exoskeleton-based exercise for improving mood and cognition in people with Parkinson's disease (PD). Participants with PD will be assigned one of three treatments delivered over 8-weeks: exoskeleton exercise (experimental intervention), non-exoskeleton exercise (active comparator)… Read more about this study

Who is it for?
Ages 50 to 85 years
What is being tested?
Exoskeleton exercise, Standard exercise and No treatment
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
41 participants
Where
2 sitesCanada
Study dates
28 Sep 2018to 4 Oct 2019
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 50 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Cognitive function score >=16 on Montreal Cognitive Assessment (MoCA)
  • Diagnosed with Parkinson's disease, Hoehn and Yahr stage 1 to 4
  • Able to walk 10 meters without stopping and without human assistance (using assistive devices such as cane or walker if normally used)
  • Waist and leg circumference and lower extremity lengths appropriate for a comfortable and safe fit in the KEEOGO device

Who cannot join

  • Legally blind
  • Treatment with another investigational drug or other intervention within the study period
  • New medications started within last 4 weeks
  • Skin condition that contraindicates use of orthotics or support braces
  • Lower-extremity amputation above or below the knee
  • Uncontrolled orthostatic hypotension
  • Psychiatric disorders such as schizophrenia or bipolar disorder
  • Other diagnosis that impairs gait and balance, such as, but not limited to, chronic obstructive pulmonary disease; peripheral arterial disease; vestibular disorders; cerebellar disease; cerebral palsy; muscular dystrophy; spinal cord injury; stroke or other brain injury; severe degenerative joint disease (osteoarthritis, rheumatoid arthritis, etc.)

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

  • The University of New Brunswick

    Fredericton, New Brunswick, E3B 5A2

  • Assistive Technology Clinic

    Toronto, Ontario, M6A2E1

Other trials in Canada

About this study

This study evaluates the benefits of exoskeleton-based exercise for improving mood and cognition in people with Parkinson's disease (PD). Participants with PD will be assigned one of three treatments delivered over 8-weeks: exoskeleton exercise (experimental intervention), non-exoskeleton exercise (active comparator), and wait-list control (no treatment).

Read the detailed description

Parkinson's Disease (PD) is a movement disorder that significantly impairs mobility and increases risk of falls. Many people with PD also experience mild cognitive impairment (MCI) and some progress to Parkinson's disease dementia (PDD). Non-pharmacologic treatments such as physical activity and exercise are known to be neuroprotective and may improve cognition, mood and overall functioning in PD, but such interventions can be challenging for individuals with PD and cognitive impairment to fully participate in. Robotic over-ground exoskeletons have the potential to overcome this barrier; however there are no scientific data yet to support the use robotic exoskeletons in the PD population or those with mood disorder and/or declining cognitive function.

This therapeutic exploratory trial will fill this gap in knowledge and provide critical data for understanding how to integrate exoskeletons into clinical practice for age-related movement disorders when cognitive decline is present. Specifically we will test if an 8-week functional exercise program (gait, balance, aerobic exercise) using the KEEOGO Rehab(tm) exoskeleton can improve mood and cognition, as well as gait and balance, compared to the same functional exercise without using the exoskeleton, and a wait-list control (no treatment).

Being tested
Exoskeleton exercise, Standard exercise, No treatment
Keywords
Exoskeleton, Functional exercise
Medical subject headings
Parkinson Disease, Dementia, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exoskeleton exerciseOther

    Functional exercise with a robotic exoskeleton

  • Standard exerciseOther

    Functional exercise without a robotic exoskeleton

  • No treatmentOther

    Wait-list control

Study groups in NCT03583879
Study groupRoleWhat they receive
Exoskeleton exerciseExperimental8-week exercise program using the exoskeleton
Receives: Other: Exoskeleton exercise
Standard exerciseActive comparator8-week exercise program not using the exoskeleton
Receives: Other: Standard exercise
No exercisePlacebo comparator8-weeks of no treatment (wait-list control)
Receives: Other: No treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in cognitive function

    10-item "Scales for Outcomes in Parkinson's-Cognition" (SCOPA-COG) instrument to evaluate cognitive function; Total score, range 0-43, higher scores = better cognitive functioning.

    Measured: Baseline and 8 weeks

  2. Change in mood

    14-item "Hospital Anxiety and Depression Scale" (HADS) instrument to measure mood disorder; Total score, range 0-42, higher scores = more severe mood disorder

    Measured: Baseline and 8 weeks

Secondary outcomes (8)

  1. Change in UPDRS Mentation score

    "Unified Parkinson's Disease Rating Scale" (UPDRS), 4-item Section I - Mentation; Sub-scale score range 0-16, higher scores = worse symptoms.

    Measured: Baseline and 8 weeks

  2. Change in UPDRS Motor score

    "Unified Parkinson's Disease Rating Scale" (UPDRS), 14-item Section III - Motor; Sub-scale range 0-108, higher scores = worse symptoms.

    Measured: Baseline and 8 weeks

  3. Change in functional balance

    Brief version of Balance Evaluation Systems Test (Brief-BESTest) for balance, average of three tests.

    Measured: Baseline and 8 weeks

  4. Change in self-report balance confidence (of not falling)

    16 item "Activity-specific Balance Confidence" (ABC) for balance self-efficacy; Total score, 0-100, is average of items scaled on 0-100% confidence in doing specific tasks without falling, higher scores = better balance confidence

    Measured: Baseline and 8 weeks

  5. Change in gait speed

    Fast walking gait speed, average of three tests.

    Measured: Baseline and 8 weeks

  6. Change in dual-task gait cost index

    Dual-task gait cost index (DTGC); Calculated index score (0-1) based on ratio of gait speed during normal gait minus gait speed with cognitive distractor divided by normal gait speed, average of three tests.

    Measured: Baseline and 8 weeks

  7. Change in dual-task cognitive cost index

    Dual-task cognitive cost index (DTCC); Calculated index score (0-1) based on ratio of correct responses during sitting minus correct responses during gait divided by correct responses while seated, average of three tests.

    Measured: Baseline and 8 weeks

  8. Change in six minute walk test score

    Distance covered with 6 min walking, average of three tests

    Measured: Baseline and 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2018
  2. Study start28 Sep 2018
  3. Primary completion4 Oct 2019
  4. Study completion4 Oct 2019

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03583879
Sponsor's protocol ID
KPD001
Status last verified
Feb 2023
First submitted
28 Jun 2018
Last updated
13 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is no individual participant data (IPD) sharing plan

Publications

  • McGibbon CA, Sexton A, Gryfe P. Exercising with a robotic exoskeleton can improve memory and gait in people with Parkinson's disease by facilitating progressive exercise intensity. Sci Rep. 2024 Feb 22;14(1):4417. doi: 10.1038/s41598-024-54200-y.

    PubMed 38388571

Questions about this trial

What is this clinical trial studying?

A study testing Exoskeleton exercise, Standard exercise and No treatment in people with Parkinson Disease and Dementia, run by University of New Brunswick at 2 sites in Canada.

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 6 inclusion and 8 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 13 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. 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. Some participants in this study may receive a placebo. 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?

Change in cognitive function (time frame: Baseline and 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03583879, which also lists 1 linked publication.

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 13 Feb 2023.

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