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Completed

NCT Number: NCT03623841

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

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.

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Key information

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Yang-Ming university

Taipei, 112, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dual-Task Training

Other

Participants in experimental group will do dual-task training via exer-game which combined with treadmill

Treadmill training

Other

Participants in control group will do treadmill training only

Primary outcomes

  1. Dual-task walking performance

    Time frame: Change from baseline at 8 weeks

    To evaluate gait parameters while doing dual-task walking

Secondary outcomes

  1. Single walking performance

    Time frame: Change from baseline at 8 weeks

    To evaluate gait parameters while doing single walking

  2. Timed up and go test

    Time frame: Change from baseline at 8 weeks

    To evaluate functional walking ability

  3. Parkinson's Disease Questionnaire 39

    Time frame: Change from baseline at 8 weeks

    To evaluate the quality of life

  4. Frontal lobe battery test-Chinese version

    Time frame: Change from baseline at 8 weeks

    To evaluate executive function

  5. Trail-making test

    Time frame: Change from baseline at 8 weeks

    To evaluate executive function

  6. Stroop color and word test-Chinese version

    Time frame: Change from baseline at 8 weeks

    To evaluate executive function

  7. Verbal fluency test-Chinese version

    Time frame: Change from baseline at 8 weeks

    To evaluate executive function

  8. Digit span test

    Time frame: Change from baseline at 8 weeks

    To evaluate executive function

  9. Dual-task effects/ costs

    Time frame: 2 months

    to compare the cost between doing dual task and single task

  10. Functional near-infrared spectroscopy

    Time frame: Change from baseline at 8 weeks

    To evaluate the changes of blood perfusion in frontal lobe

Sponsors and collaborators

Lead sponsor

National Yang Ming Chiao Tung University

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Aug 9, 2018
Registry last updated
Jul 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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