Clinical trial NCT03583879: Using Gait Robotics to Improve Symptoms of Parkinson's Disease
Official title: Using Gait Robotics to Improve Symptoms of Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Dementia
Mild Cognitive Impairment
Keywords: Exoskeleton
Functional exercise
Lead sponsor: University of New Brunswick
Sponsor class: OTHER
Collaborators: name: Centre for Aging and Brain Health Innovation
name: Assistive Technology Clinic, Canada
First posted: 2018-07-12
Enrollment: 41
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.)

Primary outcomes:
measure: Change in cognitive function
timeFrame: Baseline and 8 weeks
measure: Change in mood
timeFrame: Baseline and 8 weeks
Secondary outcomes:
measure: Change in UPDRS Mentation score
timeFrame: Baseline and 8 weeks
measure: Change in UPDRS Motor score
timeFrame: Baseline and 8 weeks
measure: Change in functional balance
timeFrame: Baseline and 8 weeks
measure: Change in self-report balance confidence (of not falling)
timeFrame: Baseline and 8 weeks
measure: Change in gait speed
timeFrame: Baseline and 8 weeks
measure: Change in dual-task gait cost index
timeFrame: Baseline and 8 weeks
measure: Change in dual-task cognitive cost index
timeFrame: Baseline and 8 weeks
measure: Change in six minute walk test score
timeFrame: Baseline and 8 weeks
Other outcomes:
measure: Change in freezing of gait episodes
timeFrame: Baseline and 8 weeks
measure: Change in physical function, pain, emotional well-being, and other indicators of health-related quality of life
timeFrame: Baseline and 8 weeks
measure: Cumulative exercise dose
timeFrame: 2x per week for 8 weeks
Locations:
city: Fredericton
country: Canada
facility: The University of New Brunswick
state: New Brunswick
city: Toronto
country: Canada
facility: Assistive Technology Clinic
state: Ontario
Study officials:
affiliation: Assistive Technology Clinic, Baycrest
name: Pearl Gryfe
role: PRINCIPAL_INVESTIGATOR
References: