Using Gait Robotics to Improve Symptoms of Parkinson's Disease

University of New Brunswick41 enrolled

Overview

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).

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Parkinson Disease Dementia Mild Cognitive Impairment

Interventions

Exoskeleton exerciseOTHER

Functional exercise with a robotic exoskeleton

Standard exerciseOTHER

Functional exercise without a robotic exoskeleton

No treatmentOTHER

Wait-list control

Eligibility

Sex: ALLMin age: 50 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.)

Locations (2)

The University of New Brunswick

Fredericton, New Brunswick, Canada

Assistive Technology Clinic

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

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.