Using Gait Robotics to Improve Symptoms of Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

Using Gait Robotics to Improve Symptoms of Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03583879
• Other study ID #: KPD001
• Status: Completed
• Phase: N/A
• Start date: September 28, 2018
• Est. completion date: October 4, 2019

Study information

• Verified date: February 2023
• Source: University of New Brunswick
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: October 4, 2019
• Est. primary completion date: October 4, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Dementia
• Mild Cognitive Impairment
• Parkinson Disease

Intervention

Other:
• Exoskeleton exercise
Functional exercise with a robotic exoskeleton
• Standard exercise
Functional exercise without a robotic exoskeleton
• No treatment
Wait-list control

Locations

Country	Name	City	State
Canada	The University of New Brunswick	Fredericton	New Brunswick
Canada	Assistive Technology Clinic	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
University of New Brunswick	Assistive Technology Clinic, Canada, Centre for Aging and Brain Health Innovation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	Cumulative exercise dose	Actigraph activity monitor for quantifying cumulative energy expenditure	2x per week for 8 weeks
Primary	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
Primary	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	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
Secondary	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
Secondary	Change in functional balance	Brief version of Balance Evaluation Systems Test (Brief-BESTest) for balance, average of three tests.	Baseline and 8 weeks
Secondary	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
Secondary	Change in gait speed	Fast walking gait speed, average of three tests.	Baseline and 8 weeks
Secondary	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
Secondary	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
Secondary	Change in six minute walk test score	Distance covered with 6 min walking, average of three tests	Baseline and 8 weeks