Using Gait Robotics to Improve Symptoms of Parkinson's Disease

NCT03583879 | Completed

• 1 other identifier: KPD001
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 2

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).

Conditions

Parkinson Disease; Dementia; Mild Cognitive Impairment

Keywords

Exoskeleton; Functional exercise

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Change in UPDRS Mentation score

  Baseline and 8 weeks

• Change in UPDRS Motor score

  Baseline and 8 weeks

• Change in functional balance

  Baseline and 8 weeks

• Change in self-report balance confidence (of not falling)

  Baseline and 8 weeks

• Change in gait speed

  Baseline and 8 weeks

Other Outcomes (3)

• Change in freezing of gait episodes

  Baseline and 8 weeks

• Change in physical function, pain, emotional well-being, and other indicators of health-related quality of life

  Baseline and 8 weeks

• Cumulative exercise dose

  2x per week for 8 weeks

Study Arms (3)

Exoskeleton exercise

EXPERIMENTAL

8-week exercise program using the exoskeleton

Other: Exoskeleton exercise

Standard exercise

ACTIVE COMPARATOR

8-week exercise program not using the exoskeleton

Other: Standard exercise

No exercise

PLACEBO COMPARATOR

8-weeks of no treatment (wait-list control)

Other: No treatment

Interventions

Exoskeleton exercise OTHER

Functional exercise with a robotic exoskeleton

Exoskeleton exercise

Standard exercise OTHER

Functional exercise without a robotic exoskeleton

Standard exercise

No treatment OTHER

Wait-list control

No exercise

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• University of New Brunswick: lead
• Centre for Aging and Brain Health Innovation: collaborator
• Assistive Technology Clinic, Canada: collaborator

Study Sites (2)

The University of New Brunswick

Fredericton, New Brunswick, E3B 5A2, Canada

Location

Assistive Technology Clinic

Toronto, Ontario, M6A2E1, Canada

Location

Related Publications (1)

• 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.

  PMID: 38388571 DERIVED

MeSH Terms

Conditions

Parkinson Disease; Dementia; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

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

Study Officials

• Pearl Gryfe

  Assistive Technology Clinic, Baycrest

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Faculty of Kinesiology

Study Record Dates

• First Submitted: June 28, 2018
• First Posted: July 12, 2018
• Study Start: September 28, 2018
• Primary Completion: October 4, 2019
• Study Completion: October 4, 2019
• Last Updated: February 13, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)