- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04033393
Dual-task Performance in Young-onset PD
July 25, 2019 updated by: Yea-Ru Yang, National Yang Ming University
Decrement of the Dual-task Performance in Individuals With Young-onset Parkinson's Disease and the Training Effects
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.
Study Overview
Status
Unknown
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yang Yearu, Ph.D.
- Phone Number: +88628267279
- Email: yryang@ym.edu.tw
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Game based dual-task training group
Participants in dual-task training group will execute game based dual-task training with treadmill, 3 times per week for 8 weeks
|
Participants in the experimental group will receive game based dual-task training with a treadmill
|
Active Comparator: Treadmill training group
Participants in treadmill training group will do treadmill training, 3 times per week for 8 weeks
|
Participants in the control group will receive treadmill training
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dual-task walking performance
Time Frame: Change from baseline at 8 weeks
|
To evaluate gait parameters while doing dual-task walking
|
Change from baseline at 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Single walking performance
Time Frame: Change from baseline at 8 weeks
|
To evaluate gait parameters while doing single walking
|
Change from baseline at 8 weeks
|
Timed up and go test
Time Frame: Change from baseline at 8 weeks
|
To evaluate functional walking ability
|
Change from baseline at 8 weeks
|
Parkinson's Disease Questionnaire 39
Time Frame: Change from baseline at 8 weeks
|
To evaluate the quality of life
|
Change from baseline at 8 weeks
|
Frontal lobe battery test-Chinese version
Time Frame: Change from baseline at 8 weeks
|
To evaluate executive function
|
Change from baseline at 8 weeks
|
Trail-making test
Time Frame: Change from baseline at 8 weeks
|
To evaluate executive function
|
Change from baseline at 8 weeks
|
Stroop color and word test-Chinese version
Time Frame: Change from baseline at 8 weeks
|
To evaluate executive function
|
Change from baseline at 8 weeks
|
Verbal fluency test-Chinese version
Time Frame: Change from baseline at 8 weeks
|
To evaluate executive function
|
Change from baseline at 8 weeks
|
Digit span test
Time Frame: Change from baseline at 8 weeks
|
To evaluate executive function
|
Change from baseline at 8 weeks
|
Dual-task costs
Time Frame: Change from baseline at 8 weeks
|
To compare the cost between doing dual task and single task
|
Change from baseline at 8 weeks
|
Functional near-infrared spectroscopy
Time Frame: Change from baseline at 8 weeks
|
To evaluate the changes of blood perfusion in frontal lobe
|
Change from baseline at 8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
August 1, 2019
Primary Completion (Anticipated)
July 31, 2022
Study Completion (Anticipated)
July 31, 2022
Study Registration Dates
First Submitted
July 24, 2019
First Submitted That Met QC Criteria
July 24, 2019
First Posted (Actual)
July 26, 2019
Study Record Updates
Last Update Posted (Actual)
July 29, 2019
Last Update Submitted That Met QC Criteria
July 25, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-05-005C
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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