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Changes in Metabolic Activity, and Gait Function by Dual-task Cognitive Game-based Treadmill Intervention in Parkinson's Disease. (CMAGDT)

Primary Purpose

Parkinson Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Game based treadmill Program
Conventional Gait Rehabilitation
Sponsored by
University of Manitoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Parkinson Disease focused on measuring Dual task walking, Treadmill walking, PET scans, Parkinson Disease

Eligibility Criteria

55 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: (PD Participants)

  • Diagnosed with idiopathic PD, defined by the UK Brain Bank criterion in disease stage 2 - 3 (classified by Hoehn and Yahr scale),
  • Montreal cognitive assessment (MoCA) scores to be 25 or higher
  • Age 55-70 years
  • Stable medications for Parkinson over the past 3 months
  • Able to walk at least 50m without any assistive device
  • Episode of FOG in the past 6 months

Exclusion Criteria: (PD Participants)

  • The presence of neurological conditions other than PD affecting cognitive abilities.
  • Any orthopedic impairment affecting gait and balance.
  • Any cardiovascular impairment limiting the ability to walk for 10-15 minutes on a treadmill;
  • Abnormal MRI
  • General contraindications.

Inclusion Criteria: (Healthy Controls)

  • Age 55-70 years,
  • Independent community living,
  • Not receiving any home care or Physiotherapy,
  • Walking outdoors for exercise for at least 3 times per week,
  • No neurological conditions affecting mobility or affecting cognitive abilities,
  • Any orthopedic impairment affecting gait and balance.
  • Any cardiovascular impairment limiting the ability to walk for 10-15 minutes on a treadmill.
  • Abnormal MRI and
  • General contraindications for PET and MRI including severe dyskinesia, diabetes, cardiac pacemakers.

Exclusion Criteria (Healthy Controls):

  • Any orthopedic impairment affecting gait and balance.
  • Any cardiovascular impairment limiting the ability to walk for 10-15 minutes on a treadmill.
  • Abnormal MRI
  • General contraindications.

Sites / Locations

  • College of Rehabilitation Sciences, University of Manitoba

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Dual-task walking Intervention

Conventional Gait Rehabilitation

Healthy Controls

Arm Description

Outcomes

Primary Outcome Measures

NDWP scores
NDWP scores on PET scans of participants will be analysed to identify gait impairment related imagining signatures during single and dual-task walking, and after intervention. They will also be compared to age-matched healthy controls using student t-test.
Step Length Coefficient of Variability

Secondary Outcome Measures

Full Information

First Posted
May 28, 2020
Last Updated
May 6, 2021
Sponsor
University of Manitoba
Collaborators
Weston Brain Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04415775
Brief Title
Changes in Metabolic Activity, and Gait Function by Dual-task Cognitive Game-based Treadmill Intervention in Parkinson's Disease.
Acronym
CMAGDT
Official Title
Changes in Metabolic Activity, and Gait Function by Dual-task Cognitive Game-based Treadmill Intervention in Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2021 (Anticipated)
Primary Completion Date
August 1, 2023 (Anticipated)
Study Completion Date
November 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manitoba
Collaborators
Weston Brain Institute

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
The present proposal will evaluate the neural underpinnings of (a) the decline of mobility function in Parkinson's disease (PD), and (b) the effects of an innovative computer-guided dual-task (DT) mobility training platform (complementary approach: exercise intervention). Improved mobility functioning in PD, specifically balance, gait and cognition, directly translates to improved community ambulation as well as increased physical activity and social participation. These benefits are known to have a significant preventive and disease-modifying impact that surpasses any currently available pharmacological interventions. Outcomes of this research will provide new insights into brain plasticity mechanisms and will accelerate further optimization and commercialization of multi-modal mobility-cognitive training applications along with accompanying smart electronic monitoring tools. With wider usage of this training platform, rehabilitation specialists will be able to effectively scale services, while still monitoring quality and ensuring accountability. Thus, the study is highly transformative.
Detailed Description
The present proposal will evaluate the neural underpinnings of (a) the decline of mobility function in Parkinson's disease (PD), and (b) the effects of an innovative computer-guided dual-task (DT) mobility training platform (complementary approach: exercise intervention). Improved mobility functioning in PD, specifically balance, gait and cognition, directly translates to improved community ambulation as well as increased physical activity and social participation. These benefits are known to have a significant preventive and disease-modifying impact that surpasses any currently available pharmacological interventions. Outcomes of this research will provide new insights into brain plasticity mechanisms and will accelerate further optimization and commercialization of multi-modal mobility-cognitive training applications along with accompanying smart electronic monitoring tools. With wider usage of this training platform, rehabilitation specialists will be able to effectively scale services, while still monitoring quality and ensuring accountability. Thus, the study is highly transformative. The investigators propose a collaborative project between our research centers at the University of Manitoba and the University of Toronto, to further understand the neural underpinnings of cognition/gait impairment and the effects of DT training in PD. Cutting-edge behavioural brain imaging methods will be used to identify functional brain metabolic network re-organization and the molecular basis of gait/cognitive impairment. This will be used to evaluate the neurophysiological underpinnings of the DT treadmill training effect, which has repeatedly demonstrated to be clinically effective. The possibility of detecting these changes and localizing the site(s) of brain plasticity will have important implications at several levels. These biomarkers could be used as an indicator of disease severity, outcome measures for neuroprotection studies and other treatment and lifestyle strategies. Objective 1: To characterize the abnormal brain metabolic pattern in PD patients during DT-walking as compared to healthy age-matched controls. Objective 2: The investigators will examine whether a 10-week treadmill walking program combined with specific cognitive activities (i.e. true DT walking training known to improve gait function and reduce falls) will "normalize" the brain abnormality (that is identified in Aim 1), or whether it will activate a novel compensatory mechanism and therefore evidence to isolate the region(s) of brain plasticity. The hypothesis is that the DT gait-related abnormal brain metabolic pattern and abnormally elevated amyloid deposition are inter-related and that these abnormal functional connectivity patterns and structural changes are highly associated with gait, cognitive and DT walking deficits in PD. It is also hypothesized that the DT treadmill-training program will result in specific and significant changes in the DT gait-related abnormal brain metabolic pattern, in the PD participants.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Dual task walking, Treadmill walking, PET scans, Parkinson Disease

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
One experimental group and other control group receiving control intervention.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
67 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dual-task walking Intervention
Arm Type
Experimental
Arm Title
Conventional Gait Rehabilitation
Arm Type
Active Comparator
Arm Title
Healthy Controls
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Game based treadmill Program
Intervention Description
Participants will be expected to play several cognitive computer games while standing on a sponge pad (10-min warm-up and while walking on the treadmill at your self-selected comfortable speed. (Dual-task treadmill training). This would be done in intervals of 2-4 min with rest periods for a total time of 35 minutes Treadmill speed and the difficulty level of the cognitive games will progress depending on participant performance and comfort level.
Intervention Type
Other
Intervention Name(s)
Conventional Gait Rehabilitation
Intervention Description
Participants will undergo a mixture of current gait training programs available for people with Parkinson's Disease. The protocol will be a Warm-up exercise consisting of rhythmical large movements (10 minutes), as well as video game practice while standing (i.e., single-task; 10 minutes). Treadmill walking in intervals of 2-4 minutes with rest periods. Walking over the ground while negotiating through obstacles. (10 minutes) The speed of the treadmill will be progressed gradually and as tolerated.
Primary Outcome Measure Information:
Title
NDWP scores
Description
NDWP scores on PET scans of participants will be analysed to identify gait impairment related imagining signatures during single and dual-task walking, and after intervention. They will also be compared to age-matched healthy controls using student t-test.
Time Frame
10 weeks
Title
Step Length Coefficient of Variability
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: (PD Participants) Diagnosed with idiopathic PD, defined by the UK Brain Bank criterion in disease stage 2 - 3 (classified by Hoehn and Yahr scale), Montreal cognitive assessment (MoCA) scores to be 25 or higher Age 55-70 years Stable medications for Parkinson over the past 3 months Able to walk at least 50m without any assistive device Episode of FOG in the past 6 months Exclusion Criteria: (PD Participants) The presence of neurological conditions other than PD affecting cognitive abilities. Any orthopedic impairment affecting gait and balance. Any cardiovascular impairment limiting the ability to walk for 10-15 minutes on a treadmill; Abnormal MRI General contraindications. Inclusion Criteria: (Healthy Controls) Age 55-70 years, Independent community living, Not receiving any home care or Physiotherapy, Walking outdoors for exercise for at least 3 times per week, No neurological conditions affecting mobility or affecting cognitive abilities, Any orthopedic impairment affecting gait and balance. Any cardiovascular impairment limiting the ability to walk for 10-15 minutes on a treadmill. Abnormal MRI and General contraindications for PET and MRI including severe dyskinesia, diabetes, cardiac pacemakers. Exclusion Criteria (Healthy Controls): Any orthopedic impairment affecting gait and balance. Any cardiovascular impairment limiting the ability to walk for 10-15 minutes on a treadmill. Abnormal MRI General contraindications.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tony Szturm, PhD
Phone
(204)-787-4794
Email
tony.szturm@umanitoba.ca
Facility Information:
Facility Name
College of Rehabilitation Sciences, University of Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0T6
Country
Canada

12. IPD Sharing Statement

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Changes in Metabolic Activity, and Gait Function by Dual-task Cognitive Game-based Treadmill Intervention in Parkinson's Disease.

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