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

Sponsor
National Yang Ming University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03623841
Collaborator
(none)
50
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2
32.3
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Dual-task training
  • Other: Treadmill training
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Nov 9, 2018
Anticipated Primary Completion Date :
Jul 18, 2021
Anticipated Study Completion Date :
Jul 18, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Dual-task walking performance [Change from baseline at 8 weeks]

    To evaluate gait parameters while doing dual-task walking

Secondary Outcome Measures

  1. Single walking performance [Change from baseline at 8 weeks]

    To evaluate gait parameters while doing single walking

  2. Timed up and go test [Change from baseline at 8 weeks]

    To evaluate functional walking ability

  3. Parkinson's Disease Questionnaire 39 [Change from baseline at 8 weeks]

    To evaluate the quality of life

  4. Frontal lobe battery test-Chinese version [Change from baseline at 8 weeks]

    To evaluate executive function

  5. Trail-making test [Change from baseline at 8 weeks]

    To evaluate executive function

  6. Stroop color and word test-Chinese version [Change from baseline at 8 weeks]

    To evaluate executive function

  7. Verbal fluency test-Chinese version [Change from baseline at 8 weeks]

    To evaluate executive function

  8. Digit span test [Change from baseline at 8 weeks]

    To evaluate executive function

  9. Dual-task effects/ costs [2 months]

    to compare the cost between doing dual task and single task

  10. Functional near-infrared spectroscopy [Change from baseline at 8 weeks]

    To evaluate the changes of blood perfusion in frontal lobe

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Yang-Ming university Taipei Taiwan 112

Sponsors and Collaborators

  • National Yang Ming University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yea-Ru Yang, Professor, National Yang Ming University
ClinicalTrials.gov Identifier:
NCT03623841
Other Study ID Numbers:
  • 17MMHIS193
First Posted:
Aug 9, 2018
Last Update Posted:
Aug 1, 2019
Last Verified:
Jul 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Yea-Ru Yang, Professor, National Yang Ming University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 1, 2019