Using Gait Robotics to Improve Symptoms of Parkinson's Disease

• ClinicalTrials.gov Identifier: NCT03583879
• Recruitment Status: Completed
• First Posted: July 12, 2018
• Last Update Posted: December 8, 2020
• Sponsor: Baycrest
• Collaborators: Centre for Aging and Brain Health Innovation; University of New Brunswick
• Information provided by (Responsible Party): Pearl Gryfe, Baycrest

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Parkinson Disease; Dementia; Mild Cognitive Impairment	Other: Exoskeleton exercise; Other: Standard exercise; Other: No treatment	Not Applicable

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).

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 41 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Using Gait Robotics to Improve Symptoms of Parkinson's Disease
• Actual Study Start Date: September 28, 2018
• Actual Primary Completion Date: October 4, 2019
• Actual Study Completion Date: October 4, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Change in cognitive function [ Time Frame: 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.
2. Change in mood [ Time Frame: 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 Outcome Measures :

1. Change in UPDRS Mentation score [ Time Frame: 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.
2. Change in UPDRS Motor score [ Time Frame: 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.
3. Change in functional balance [ Time Frame: Baseline and 8 weeks ]
   Brief version of Balance Evaluation Systems Test (Brief-BESTest) for balance, average of three tests.
4. Change in self-report balance confidence (of not falling) [ Time Frame: 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
5. Change in gait speed [ Time Frame: Baseline and 8 weeks ]
   Fast walking gait speed, average of three tests.
6. Change in dual-task gait cost index [ Time Frame: 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.
7. Change in dual-task cognitive cost index [ Time Frame: 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.
8. Change in six minute walk test score [ Time Frame: Baseline and 8 weeks ]
   Distance covered with 6 min walking, average of three tests

Other Outcome Measures:

1. Change in freezing of gait episodes [ Time Frame: 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.
2. Change in physical function, pain, emotional well-being, and other indicators of health-related quality of life [ Time Frame: 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
3. Cumulative exercise dose [ Time Frame: 2x per week for 8 weeks ]
   Actigraph activity monitor for quantifying cumulative energy expenditure

Eligibility Criteria

• Ages Eligible for Study: 50 Years to 85 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.)

Contacts and Locations

Locations

Canada, Ontario

Assistive Technology Clinic

Toronto, Ontario, Canada, M6A2E1

Sponsors and Collaborators

Baycrest

Centre for Aging and Brain Health Innovation

University of New Brunswick

Investigators

• Principal Investigator: Pearl Gryfe; Assistive Technology Clinic, Baycrest

More Information

• Responsible Party: Pearl Gryfe, Clinical and Managing Director, Assistive Technology Clinic, Baycrest
• ClinicalTrials.gov Identifier: NCT03583879
• Other Study ID Numbers: KPD001
• First Posted: July 12, 2018
• Last Update Posted: December 8, 2020
• Last Verified: December 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: There is no individual participant data (IPD) sharing plan

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pearl Gryfe, Baycrest:

Exoskeleton; Functional exercise

Additional relevant MeSH terms:

Parkinson Disease; Cognitive Dysfunction; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders