Dual-task Performance in Young-onset PD
Primary Purpose
Early Onset Parkinson Disease, Early Stage Parkinson Disease
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Game based dual-task training
Treadmill training
Sponsored by
About this trial
This is an interventional treatment trial for Early Onset Parkinson Disease focused on measuring Executive function, Dual-task performance, Dual-task training
Eligibility Criteria
Inclusion Criteria:
- Diagnosed as PD and Hoehn and Yahr stage between 1~3
- Age between 20 to 80
- Able to walk 10 m independently without an assistive device
- A score of greater than or equal to 24 on the mini-mental state examination (MMSE)
- In stable medical condition allowing participation in the testing protocol and intervention
Exclusion Criteria:
- Any comorbidity or disability other than PD that would preclude gait training
- Any uncontrolled health condition for which exercise was contraindicated
- Any neurological or orthopedic disease that might interfere with the study
- Server freezing of gait, FOG questionnaire > 15
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Game based dual-task training group
Treadmill training group
Arm Description
Participants in dual-task training group will execute game based dual-task training with treadmill, 3 times per week for 8 weeks
Participants in treadmill training group will do treadmill training, 3 times per week for 8 weeks
Outcomes
Primary Outcome Measures
Dual-task walking performance
To evaluate gait parameters while doing dual-task walking
Secondary Outcome Measures
Single walking performance
To evaluate gait parameters while doing single walking
Timed up and go test
To evaluate functional walking ability
Parkinson's Disease Questionnaire 39
To evaluate the quality of life
Frontal lobe battery test-Chinese version
To evaluate executive function
Trail-making test
To evaluate executive function
Stroop color and word test-Chinese version
To evaluate executive function
Verbal fluency test-Chinese version
To evaluate executive function
Digit span test
To evaluate executive function
Dual-task costs
To compare the cost between doing dual task and single task
Functional near-infrared spectroscopy
To evaluate the changes of blood perfusion in frontal lobe
Full Information
NCT ID
NCT04033393
First Posted
July 24, 2019
Last Updated
July 25, 2019
Sponsor
National Yang Ming University
1. Study Identification
Unique Protocol Identification Number
NCT04033393
Brief Title
Dual-task Performance in Young-onset PD
Official Title
Decrement of the Dual-task Performance in Individuals With Young-onset Parkinson's Disease and the Training Effects
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2019 (Anticipated)
Primary Completion Date
July 31, 2022 (Anticipated)
Study Completion Date
July 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Yang Ming University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study aimed to investigate the effects of Game based dual-task training with treadmill on executive function and dual-task performance in individuals with early-onset PD and discuss the correlation between the change values of executive function and dual-task performance after training. Besides, investigate cortical activation after training.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Early Onset Parkinson Disease, Early Stage Parkinson Disease
Keywords
Executive function, Dual-task performance, Dual-task training
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Game based dual-task training group
Arm Type
Experimental
Arm Description
Participants in dual-task training group will execute game based dual-task training with treadmill, 3 times per week for 8 weeks
Arm Title
Treadmill training group
Arm Type
Active Comparator
Arm Description
Participants in treadmill training group will do treadmill training, 3 times per week for 8 weeks
Intervention Type
Other
Intervention Name(s)
Game based dual-task training
Intervention Description
Participants in the experimental group will receive game based dual-task training with a treadmill
Intervention Type
Other
Intervention Name(s)
Treadmill training
Intervention Description
Participants in the control group will receive treadmill training
Primary Outcome Measure Information:
Title
Dual-task walking performance
Description
To evaluate gait parameters while doing dual-task walking
Time Frame
Change from baseline at 8 weeks
Secondary Outcome Measure Information:
Title
Single walking performance
Description
To evaluate gait parameters while doing single walking
Time Frame
Change from baseline at 8 weeks
Title
Timed up and go test
Description
To evaluate functional walking ability
Time Frame
Change from baseline at 8 weeks
Title
Parkinson's Disease Questionnaire 39
Description
To evaluate the quality of life
Time Frame
Change from baseline at 8 weeks
Title
Frontal lobe battery test-Chinese version
Description
To evaluate executive function
Time Frame
Change from baseline at 8 weeks
Title
Trail-making test
Description
To evaluate executive function
Time Frame
Change from baseline at 8 weeks
Title
Stroop color and word test-Chinese version
Description
To evaluate executive function
Time Frame
Change from baseline at 8 weeks
Title
Verbal fluency test-Chinese version
Description
To evaluate executive function
Time Frame
Change from baseline at 8 weeks
Title
Digit span test
Description
To evaluate executive function
Time Frame
Change from baseline at 8 weeks
Title
Dual-task costs
Description
To compare the cost between doing dual task and single task
Time Frame
Change from baseline at 8 weeks
Title
Functional near-infrared spectroscopy
Description
To evaluate the changes of blood perfusion in frontal lobe
Time Frame
Change from baseline at 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosed as PD and Hoehn and Yahr stage between 1~3
Age between 20 to 80
Able to walk 10 m independently without an assistive device
A score of greater than or equal to 24 on the mini-mental state examination (MMSE)
In stable medical condition allowing participation in the testing protocol and intervention
Exclusion Criteria:
Any comorbidity or disability other than PD that would preclude gait training
Any uncontrolled health condition for which exercise was contraindicated
Any neurological or orthopedic disease that might interfere with the study
Server freezing of gait, FOG questionnaire > 15
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yang Yearu, Ph.D.
Phone
+88628267279
Email
yryang@ym.edu.tw
12. IPD Sharing Statement
Learn more about this trial
Dual-task Performance in Young-onset PD
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