Using Gait Robotics to Improve Symptoms of Parkinson's Disease

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).

Study Overview

• Status: Completed
• Conditions: Parkinson Disease; Dementia; Mild Cognitive Impairment
• Intervention / Treatment: Other: Exoskeleton exercise; Other: Standard exercise; Other: 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).

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • New Brunswick
    • Fredericton, New Brunswick, Canada, E3B 5A2
      • The University of New Brunswick
  • Ontario
    • Toronto, Ontario, Canada, M6A2E1
      • Assistive Technology Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University of New Brunswick
• Collaborators: Centre for Aging and Brain Health Innovation; Assistive Technology Clinic, Canada

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 28, 2018
• Primary Completion (ACTUAL): October 4, 2019
• Study Completion (ACTUAL): October 4, 2019

Study Registration Dates

• First Submitted: June 28, 2018
• First Submitted That Met QC Criteria: July 10, 2018
• First Posted (ACTUAL): July 12, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 13, 2023
• Last Update Submitted That Met QC Criteria: February 8, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Exoskeleton; Functional exercise
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Cognition Disorders; Parkinson Disease; Cognitive Dysfunction
• Other Study ID Numbers: KPD001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no individual participant data (IPD) sharing plan

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No