Using Gait Robotics to Improve Symptoms of Parkinson's Disease

Study Overview
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Brief Summary
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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
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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).

Official Title
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Using Gait Robotics to Improve Symptoms of Parkinson's Disease

Conditions
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Parkinson Disease, Dementia, Mild Cognitive Impairment

Intervention / Treatment
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* Other: Exoskeleton exercise
* Other: Standard exercise
* Other: No treatment


Participation Criteria
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Eligibility Criteria
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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.)

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exoskeleton exercise<br>8-week exercise program using the exoskeleton | Other: Exoskeleton exercise<br>* Functional exercise with a robotic exoskeleton<br>|
| Active Comparator: Standard exercise<br>8-week exercise program not using the exoskeleton | Other: Standard exercise<br>* Functional exercise without a robotic exoskeleton<br>|
| Placebo Comparator: No exercise<br>8-weeks of no treatment (wait-list control) | Other: No treatment<br>* Wait-list control<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and 8 weeks | 
| Change in mood | 14-item Hospital Anxiety and Depression Scale (HADS) instrument to measure mood disorder; Total score, range 0-42, higher scores = more severe mood disorder | Baseline and 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in UPDRS Mentation score | Unified Parkinson's Disease Rating Scale (UPDRS), 4-item Section I - Mentation; Sub-scale score range 0-16, higher scores = worse symptoms. | Baseline and 8 weeks | 
| Change in UPDRS Motor score | Unified Parkinson's Disease Rating Scale (UPDRS), 14-item Section III - Motor; Sub-scale range 0-108, higher scores = worse symptoms. | Baseline and 8 weeks | 
| Change in functional balance | Brief version of Balance Evaluation Systems Test (Brief-BESTest) for balance, average of three tests. | Baseline and 8 weeks | 
| Change in self-report balance confidence (of not falling) | 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 | Baseline and 8 weeks | 
| Change in gait speed | Fast walking gait speed, average of three tests. | Baseline and 8 weeks | 
| Change in dual-task gait cost index | 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. | Baseline and 8 weeks | 
| Change in dual-task cognitive cost index | 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. | Baseline and 8 weeks | 
| Change in six minute walk test score | Distance covered with 6 min walking, average of three tests | Baseline and 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exoskeleton, Functional exercise