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Clinical Trial 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT03623841
Study type Interventional
Source National Yang Ming University
Contact Yang Yearu, Ph.D.
Phone +88628267279
Email yryang@ym.edu.tw
Status Recruiting
Phase N/A
Start date November 9, 2018
Completion date July 18, 2021

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