Using Gait Robotics to Improve Symptoms of Parkinson's Disease

University of New Brunswick

Status: Completed

Conditions: Mild Cognitive Impairment; Parkinson Disease; Dementia

Treatments: Other: Standard exercise; Other: No treatment; Other: Exoskeleton exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT03583879

KPD001

Details and patient eligibility

About

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).

Full 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).

Enrollment: 41 patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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41 participants in 3 patient groups, including a placebo group

Exoskeleton exercise

Experimental group

Description:

8-week exercise program using the exoskeleton

Treatment:

Other: Exoskeleton exercise

Standard exercise

Active Comparator group

Description:

8-week exercise program not using the exoskeleton

Treatment:

Other: Standard exercise

No exercise

Placebo Comparator group

Description:

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

Treatment:

Other: No treatment