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

Stroke Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03623841
• Other study ID #: 17MMHIS193
• Status: Recruiting
• Phase: N/A
• Start date: November 9, 2018
• Est. completion date: July 18, 2021

Study information

• Verified date: July 2019
• Source: National Yang Ming University
• Contact: Yang Yearu, Ph.D.
• Phone: +88628267279
• Email: yryang[@]ym.edu.tw
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 18, 2021
• Est. primary completion date: July 18, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease
• Stroke

Intervention

Other:
• Dual-task training
Participants in experimental group will do dual-task training via exer-game which combined with treadmill
• Treadmill training
Participants in control group will do treadmill training only

Locations

Country	Name	City	State
Taiwan	National Yang-Ming university	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Yang Ming University

Country where clinical trial is conducted

Taiwan, 

Outcome

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