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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Parkinson's Disease, Stroke

Intervention / Treatment
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* Other: Dual-task training
* Other: Treadmill training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dual-task training group<br>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<br>* Participants in experimental group will do dual-task training via exer-game which combined with treadmill<br>|
| Active Comparator: Treadmill training group<br>Participants in treadmill training group will do treadmill training only, 3 times per week, least 8 weeks. | Other: Treadmill training<br>* Participants in control group will do treadmill training only<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dual-task walking performance | 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 | To evaluate gait parameters while doing single walking | Change from baseline at 8 weeks | 
| Timed up and go test | To evaluate functional walking ability | Change from baseline at 8 weeks | 
| Parkinson's Disease Questionnaire 39 | To evaluate the quality of life | Change from baseline at 8 weeks | 
| Frontal lobe battery test-Chinese version | To evaluate executive function | Change from baseline at 8 weeks | 
| Trail-making test | To evaluate executive function | Change from baseline at 8 weeks | 
| Stroop color and word test-Chinese version | To evaluate executive function | Change from baseline at 8 weeks | 
| Verbal fluency test-Chinese version | To evaluate executive function | Change from baseline at 8 weeks | 
| Digit span test | To evaluate executive function | Change from baseline at 8 weeks | 
| Dual-task effects/ costs | to compare the cost between doing dual task and single task | 2 months | 
| Functional near-infrared spectroscopy | To evaluate the changes of blood perfusion in frontal lobe | Change from baseline at 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Executive function, Dual-task performance, Dual-task training