Dementia, Mild Cognitive Impairment, Parkinson Disease
Conditions
Keywords
Exoskeleton, Functional exercise
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).
Interventions
OTHERExoskeleton exercise
Functional exercise with a robotic exoskeleton
OTHERStandard exercise
Functional exercise without a robotic exoskeleton
OTHERNo treatment
Wait-list control
Sponsors
Centre for Aging and Brain Health Innovation
Assistive Technology Clinic, Canada
University of New Brunswick
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No
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.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in cognitive function | Baseline and 8 weeks | 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. |
| Change in mood | Baseline and 8 weeks | 14-item Hospital Anxiety and Depression Scale (HADS) instrument to measure mood disorder; Total score, range 0-42, higher scores = more severe mood disorder |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in six minute walk test score | Baseline and 8 weeks | Distance covered with 6 min walking, average of three tests |
| Change in gait speed | Baseline and 8 weeks | Fast walking gait speed, average of three tests. |
| Change in dual-task gait cost index | Baseline and 8 weeks | 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. |
| Change in dual-task cognitive cost index | Baseline and 8 weeks | 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. |
| Change in UPDRS Mentation score | Baseline and 8 weeks | Unified Parkinson's Disease Rating Scale (UPDRS), 4-item Section I - Mentation; Sub-scale score range 0-16, higher scores = worse symptoms. |
| Change in UPDRS Motor score | Baseline and 8 weeks | Unified Parkinson's Disease Rating Scale (UPDRS), 14-item Section III - Motor; Sub-scale range 0-108, higher scores = worse symptoms. |
| Change in functional balance | Baseline and 8 weeks | Brief version of Balance Evaluation Systems Test (Brief-BESTest) for balance, average of three tests. |
| Change in self-report balance confidence (of not falling) | Baseline and 8 weeks | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cumulative exercise dose | 2x per week for 8 weeks | Actigraph activity monitor for quantifying cumulative energy expenditure |
| Change in physical function, pain, emotional well-being, and other indicators of health-related quality of life | Baseline and 8 weeks | 39-item Parkinson's Disease health-related Quality of life (PDQ-39) survey; Total score, 0-195, higher scores = worse health-related quality of life |
| Change in freezing of gait episodes | Baseline and 8 weeks | 6-item Freezing of Gait Questionnaire (FoG-Q) for measuring the impact of freezing of gait on mobility; Total score, range 0-24, higher scores = worse symptoms. |
Countries
Canada
Outcome results
None listed