Study Stopped
Lack of Recruitment
Evaluating Effect of Cognitive Game Based Treadmill Exercise Program in Parkinson Disease
Evaluating the Use of a Cognitive Game-Based Treadmill Exercise Program to Improve Balance and Gait in People With Parkinson Disease: A Feasibility Randomized Controlled Trial
1 other identifier
interventional
30
1 country
1
Brief Summary
An inexpensive dual-task gait training protocol has been developed for people with PD namely game based treadmill platform. A feasibility randomized trial clinical trail will be conducted to evaluate the feasibility, acceptability and estimate treatment effect size of the treatment protocol to conduct a future RCT.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 parkinson-disease
Started Mar 2019
Shorter than P25 for phase_1 parkinson-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 18, 2019
CompletedFirst Posted
Study publicly available on registry
February 8, 2019
CompletedStudy Start
First participant enrolled
March 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2019
CompletedMarch 25, 2020
January 1, 2019
4 months
January 18, 2019
March 23, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Retention to GTP
Percentage of participants adhering to 10 Weeks of GTP protocol.
1 year
Secondary Outcomes (1)
Sample size calculation
1 Year
Study Arms (2)
Intervention group
EXPERIMENTALIntervention Group: Participants in the intervention group will receive DT TT with GTP. GTP consists of standard treadmill nested with a pressure mapping system and an interactive computer game based sub-station in front of the treadmill. A miniature motion mouse with inbuilt sensors that enables "real-time" movements to be translated in computer sub-station by standard USB will be used. This miniature mouse will be secured to a helmet that participants will wear while walking on the treadmill to interact with computer sub-station. Participants will be expected to play commercial computer games while standing on compliant surface or walking on the treadmill. The motion mouse will help participants to control computer games hand free.
Control Group
ACTIVE COMPARATORControl group: Participants in the control group will undergo a mixture of current gait training programs available for people with Parkinson Disease. The protocol will be:
Interventions
The protocol for the intervention group will be: * Warm up exercised consisting of rhythmical large movements (10minutes) * Dynamic standing balance training by playing commercial games with head rotations while standing on a compliant surface to increase balance demands. (10 Minutes) * DT treadmill training, consisting of playing commercial computer games while walking on the treadmill at a self-selected comfortable speed. Participants will be allowed to take rest when required and total effective DT treadmill walking will be for 30minutes. Treadmill speed will be aimed to progress depending on participant performance and documented. An overhead safety harness will always be provided to participants while walking on the treadmill. (25minutes)
* Warm-up exercise consisting of rhythmical large movements (10 minutes). * Core standing balance exercises on a sponge surface (10 minutes). * Treadmill walking for 20 minutes, which includes rests periods... An overhead safety harness will be provided to participants while walking on the treadmill * Overground walking in an obstacle course. Participants will be instructed to walk along a curved path (marked by tape) and avoid obstacles placed randomly. The obstacle will be thin sponge pads with 10-12 inches in diameter (15minutes).
Eligibility Criteria
You may qualify if:
- Age range 55-70
- Diagnosed with PD according to UK brain bank criteria,
- PD stage 1-3 on Hoehn and Yahr scale,
- On stable medications for PD from past 3months,
- Able to walk 50m independently,
- Montreal Cognitive Assessment( MoCA) score of more than 21(Non-Dementia PD).
You may not qualify if:
- Any other neurodegenerative condition,
- Any orthopedic or cardiovascular impairment limiting independent walking for a minimum of 10 minutes.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
College of Rehabilitation Sciences, University of Manitoba
Winnipeg, Manitoba, R3E 0T6, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 18, 2019
First Posted
February 8, 2019
Study Start
March 1, 2019
Primary Completion
July 1, 2019
Study Completion
August 1, 2019
Last Updated
March 25, 2020
Record last verified: 2019-01