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Using Gait Robotics to Improve Symptoms of Parkinson's Disease

Primary Purpose

Parkinson Disease, Dementia, Mild Cognitive Impairment

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Exoskeleton exercise
Standard exercise
No treatment
Sponsored by
University of New Brunswick
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Exoskeleton, Functional exercise

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.)

Sites / Locations

  • The University of New Brunswick
  • Assistive Technology Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Exoskeleton exercise

Standard exercise

No exercise

Arm Description

8-week exercise program using the exoskeleton

8-week exercise program not using the exoskeleton

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

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

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.
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.
Change in functional balance
Brief version of Balance Evaluation Systems Test (Brief-BESTest) for balance, average of three tests.
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
Change in gait speed
Fast walking gait speed, average of three tests.
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.
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.
Change in six minute walk test score
Distance covered with 6 min walking, average of three tests

Full Information

First Posted
June 28, 2018
Last Updated
February 8, 2023
Sponsor
University of New Brunswick
Collaborators
Centre for Aging and Brain Health Innovation, Assistive Technology Clinic, Canada
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1. Study Identification

Unique Protocol Identification Number
NCT03583879
Brief Title
Using Gait Robotics to Improve Symptoms of Parkinson's Disease
Official Title
Using Gait Robotics to Improve Symptoms of Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
September 28, 2018 (Actual)
Primary Completion Date
October 4, 2019 (Actual)
Study Completion Date
October 4, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of New Brunswick
Collaborators
Centre for Aging and Brain Health Innovation, Assistive Technology Clinic, Canada

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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).
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Dementia, Mild Cognitive Impairment
Keywords
Exoskeleton, Functional exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exoskeleton exercise
Arm Type
Experimental
Arm Description
8-week exercise program using the exoskeleton
Arm Title
Standard exercise
Arm Type
Active Comparator
Arm Description
8-week exercise program not using the exoskeleton
Arm Title
No exercise
Arm Type
Placebo Comparator
Arm Description
8-weeks of no treatment (wait-list control)
Intervention Type
Other
Intervention Name(s)
Exoskeleton exercise
Intervention Description
Functional exercise with a robotic exoskeleton
Intervention Type
Other
Intervention Name(s)
Standard exercise
Intervention Description
Functional exercise without a robotic exoskeleton
Intervention Type
Other
Intervention Name(s)
No treatment
Intervention Description
Wait-list control
Primary Outcome Measure Information:
Title
Change in cognitive function
Description
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.
Time Frame
Baseline and 8 weeks
Title
Change in mood
Description
14-item "Hospital Anxiety and Depression Scale" (HADS) instrument to measure mood disorder; Total score, range 0-42, higher scores = more severe mood disorder
Time Frame
Baseline and 8 weeks
Secondary Outcome Measure Information:
Title
Change in UPDRS Mentation score
Description
"Unified Parkinson's Disease Rating Scale" (UPDRS), 4-item Section I - Mentation; Sub-scale score range 0-16, higher scores = worse symptoms.
Time Frame
Baseline and 8 weeks
Title
Change in UPDRS Motor score
Description
"Unified Parkinson's Disease Rating Scale" (UPDRS), 14-item Section III - Motor; Sub-scale range 0-108, higher scores = worse symptoms.
Time Frame
Baseline and 8 weeks
Title
Change in functional balance
Description
Brief version of Balance Evaluation Systems Test (Brief-BESTest) for balance, average of three tests.
Time Frame
Baseline and 8 weeks
Title
Change in self-report balance confidence (of not falling)
Description
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
Time Frame
Baseline and 8 weeks
Title
Change in gait speed
Description
Fast walking gait speed, average of three tests.
Time Frame
Baseline and 8 weeks
Title
Change in dual-task gait cost index
Description
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.
Time Frame
Baseline and 8 weeks
Title
Change in dual-task cognitive cost index
Description
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.
Time Frame
Baseline and 8 weeks
Title
Change in six minute walk test score
Description
Distance covered with 6 min walking, average of three tests
Time Frame
Baseline and 8 weeks
Other Pre-specified Outcome Measures:
Title
Change in freezing of gait episodes
Description
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.
Time Frame
Baseline and 8 weeks
Title
Change in physical function, pain, emotional well-being, and other indicators of health-related quality of life
Description
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
Time Frame
Baseline and 8 weeks
Title
Cumulative exercise dose
Description
Actigraph activity monitor for quantifying cumulative energy expenditure
Time Frame
2x per week for 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pearl Gryfe
Organizational Affiliation
Assistive Technology Clinic, Baycrest
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of New Brunswick
City
Fredericton
State/Province
New Brunswick
ZIP/Postal Code
E3B 5A2
Country
Canada
Facility Name
Assistive Technology Clinic
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6A2E1
Country
Canada

12. IPD Sharing Statement

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

Learn more about this trial

Using Gait Robotics to Improve Symptoms of Parkinson's Disease

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