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

Primary Purpose

Parkinson's Disease, Stroke

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Dual-task training
Treadmill training
Sponsored by
National Yang Ming University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Executive function, Dual-task performance, Dual-task training

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Yang-Ming universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dual-task training group

Treadmill training group

Arm Description

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.

Participants in treadmill training group will do treadmill training only, 3 times per week, least 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 effects/ 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

First Posted
July 29, 2018
Last Updated
July 31, 2019
Sponsor
National Yang Ming University
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1. Study Identification

Unique Protocol Identification Number
NCT03623841
Brief Title
Training With Exergame and Treadmill on Executive Function and Dual-task Performance
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 9, 2018 (Actual)
Primary Completion Date
July 18, 2021 (Anticipated)
Study Completion Date
July 18, 2021 (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 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease, Stroke
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
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dual-task training group
Arm Type
Experimental
Arm Description
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.
Arm Title
Treadmill training group
Arm Type
Active Comparator
Arm Description
Participants in treadmill training group will do treadmill training only, 3 times per week, least 8 weeks.
Intervention Type
Other
Intervention Name(s)
Dual-task training
Intervention Description
Participants in experimental group will do dual-task training via exer-game which combined with treadmill
Intervention Type
Other
Intervention Name(s)
Treadmill training
Intervention Description
Participants in control group will do treadmill training only
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 effects/ costs
Description
to compare the cost between doing dual task and single task
Time Frame
2 months
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
50 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yang Yearu, Ph.D.
Phone
+88628267279
Email
yryang@ym.edu.tw
Facility Information:
Facility Name
National Yang-Ming university
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhou Junhong, Student

12. IPD Sharing Statement

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

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