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| Name | Class |
|---|---|
| Centre for Aging and Brain Health Innovation | OTHER |
| Assistive Technology Clinic, Canada | OTHER |
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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).
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exoskeleton exercise | Experimental | 8-week exercise program using the exoskeleton |
|
| Standard exercise | Active Comparator | 8-week exercise program not using the exoskeleton |
|
| No exercise | Placebo Comparator | 8-weeks of no treatment (wait-list control) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exoskeleton exercise | Other | Functional exercise with a robotic exoskeleton |
| |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in freezing of gait episodes | 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. | Baseline and 8 weeks |
| Change in physical function, pain, emotional well-being, and other indicators of health-related quality of life |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pearl Gryfe | Assistive Technology Clinic, Baycrest | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of New Brunswick | Fredericton | New Brunswick | E3B 5A2 | Canada | ||
| Assistive Technology Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38388571 | Derived | McGibbon CA, Sexton A, Gryfe P. Exercising with a robotic exoskeleton can improve memory and gait in people with Parkinson's disease by facilitating progressive exercise intensity. Sci Rep. 2024 Feb 22;14(1):4417. doi: 10.1038/s41598-024-54200-y. |
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There is no individual participant data (IPD) sharing plan
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D003704 | Dementia |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Standard exercise |
| Other |
Functional exercise without a robotic exoskeleton |
|
| No treatment | Other | Wait-list control |
|
"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 |
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 |
| Baseline and 8 weeks |
| Cumulative exercise dose | Actigraph activity monitor for quantifying cumulative energy expenditure | 2x per week for 8 weeks |
| Toronto |
| Ontario |
| M6A2E1 |
| Canada |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003072 | Cognition Disorders |