Training With Exergame and Treadmill on Executive Function and Dual-task Performance

July 31, 2019 updated by: Yea-Ru Yang, National Yang Ming University

Effects of Dual-task Training With Exergame and Treadmill on Executive Function, Dual-task Performance and Cortical Activation in Individuals With Parkinson's Disease and Stroke

This study aimed to investigate the effects of dual-task training with exergame and treadmill on executive function and dual-task performance in individuals with PD and stroke 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

Conditions

Intervention / Treatment

Detailed Description

Background: In daily living, walking usually combines with cognitive or motor dual tasks. For individuals with Parkinson's disease (PD), gait performance becomes worse while doing dual tasks, which may due to insufficient executive function. Declined executive function may occur in early stage of PD. For those with stroke, impaired dual-task performance also exists. Although 75% of patients with stroke may suffer from impaired executive function, impaired dual-task performance correlates with declined executive function directly or not still unknown. Undoubtedly, impaired executive function decreases their daily activities. Recently, dual-task training by walking with secondary tasks resulted in improvement of single or dual-task gait performance in individuals with PD. As for stroke, dual-task training performed in walking with secondary tasks and resulted in improvement of single or dual-task gait performance. However, previous studies less mentioned about combine cognitive and motor tasks simultaneously with gait training. While dual-task training with exergame and treadmill can include cognitive and motor tasks simultaneously while walking. Thus, whether dual-task training with exergame and treadmill can improve executive function and dual-task performance in individuals with PD and stroke is worth to investigate. Purposes: To investigate the effects of dual-task training with exergame and treadmill on executive function and dual-task performance in individuals with PD and stroke and discuss the correlation between the change values of executive function and dual-task performance after training. Besides, investigate cortical activation after training. Methods: This research will be implemented in two phases. First phase will include 50 subjects with PD and the second phase will include 50 subjects with stroke. After pre-test, subjects will be randomly assigned into either the experimental group or the control group. Subjects in the experimental group will receive 24 sessions dual-task training with exergame and treadmill in 8 weeks; while the control group will receive treadmill training only in same frequency. Each session lasts an hour. Primary outcomes include general cognitive performance, executive function, dual-task performance, dual-task effects and cortical activation. Secondary outcomes include single walking performance, functional walking and quality of life. Statistical analysis: Descriptive statistics will be generated for all variables. Intergroup differences among baseline characteristics will be evaluated by independent t test or χ2 analysis. Primary and secondary outcomes will be analyzed by two-way repeated measures ANOVA and post-hoc test. The correlation between change values of executive function and dual-task performance will be evaluated by Pearson correlation coefficient. Statistical significance will set at P<0.05.

Study Type

Interventional

Enrollment (Anticipated)

50

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

Study Locations

  • Taiwan
      • Taipei, Taiwan, 112
        • Recruiting
        • National Yang-Ming University
        • Contact:
          • Zhou Junhong, Student

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

50 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 50 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: Dual-task training group
Participants in dual-task training group will execute dual-task training via exer-game which combined with treadmill, 3 times per week, least 8 weeks.
Other: Dual-task training
Participants in experimental group will do dual-task training via exer-game which combined with treadmill
Active Comparator: Treadmill training group
Participants in treadmill training group will do treadmill training only, 3 times per week, least 8 weeks.
Other: Treadmill training
Participants in control group will do treadmill training only

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
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
Dual-task effects/ costs
Time Frame: 2 months
to compare the cost between doing dual task and single task
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Yang Ming University

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 (Actual)

November 9, 2018

Primary Completion (Anticipated)

July 18, 2021

Study Completion (Anticipated)

July 18, 2021

Study Registration Dates

First Submitted

July 29, 2018

First Submitted That Met QC Criteria

August 6, 2018

First Posted (Actual)

August 9, 2018

Study Record Updates

Last Update Posted (Actual)

August 1, 2019

Last Update Submitted That Met QC Criteria

July 31, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17MMHIS193

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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