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

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

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.

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

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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