Clinical trial NCT03623841: 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
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Stroke
Keywords: Executive function
Dual-task performance
Dual-task training
Lead sponsor: National Yang Ming Chiao Tung University
Sponsor class: OTHER
First posted: 2018-08-09
Enrollment: 28
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Dual-task walking performance
timeFrame: Change from baseline at 8 weeks
Secondary outcomes:
measure: Single walking performance
timeFrame: Change from baseline at 8 weeks
measure: Timed up and go test
timeFrame: Change from baseline at 8 weeks
measure: Parkinson's Disease Questionnaire 39
timeFrame: Change from baseline at 8 weeks
measure: Frontal lobe battery test-Chinese version
timeFrame: Change from baseline at 8 weeks
measure: Trail-making test
timeFrame: Change from baseline at 8 weeks
measure: Stroop color and word test-Chinese version
timeFrame: Change from baseline at 8 weeks
measure: Verbal fluency test-Chinese version
timeFrame: Change from baseline at 8 weeks
measure: Digit span test
timeFrame: Change from baseline at 8 weeks
measure: Dual-task effects/ costs
timeFrame: 2 months
measure: Functional near-infrared spectroscopy
timeFrame: Change from baseline at 8 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Yang-Ming university
Study officials:
References: