Using Gait Robotics to Improve Symptoms of Parkinson's Disease

NCT ID: NCT03583879

Last Updated: 2023-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-28
• Study Completion Date: 2019-10-04

Brief 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), and wait-list control (no treatment).

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).

Conditions

Parkinson Disease; Dementia; Mild Cognitive Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Exoskeleton exercise

8-week exercise program using the exoskeleton

Group Type: EXPERIMENTAL

Exoskeleton exercise

Intervention Type: OTHER

Functional exercise with a robotic exoskeleton

Standard exercise

8-week exercise program not using the exoskeleton

Group Type: ACTIVE_COMPARATOR

Standard exercise

Intervention Type: OTHER

Functional exercise without a robotic exoskeleton

No exercise

8-weeks of no treatment (wait-list control)

Group Type: PLACEBO_COMPARATOR

No treatment

Intervention Type: OTHER

Wait-list control

Interventions

Exoskeleton exercise

Functional exercise with a robotic exoskeleton

Intervention Type: OTHER

Standard exercise

Functional exercise without a robotic exoskeleton

Intervention Type: OTHER

No treatment

Wait-list control

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.)

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre for Aging and Brain Health Innovation

OTHER

Sponsor Role: collaborator

Assistive Technology Clinic, Canada

OTHER

Sponsor Role: collaborator

University of New Brunswick

OTHER

Sponsor Role: lead

Responsible Party

Chris A. McGibbon, PhD

Professor, Faculty of Kinesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pearl Gryfe

Role: PRINCIPAL_INVESTIGATOR

Assistive Technology Clinic, Baycrest

Locations

The University of New Brunswick

Fredericton, New Brunswick, Canada

Assistive Technology Clinic

Toronto, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 38388571 (View on PubMed)

Other Identifiers

KPD001

Identifier Type: -

Identifier Source: org_study_id