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

NCT ID: NCT03623841

Last Updated: 2024-07-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-09
• Study Completion Date: 2022-08-09

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.

Conditions

Parkinson's Disease; Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Dual-task training group

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.

Group Type: EXPERIMENTAL

Dual-task training

Intervention Type: OTHER

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

Treadmill training group

Participants in treadmill training group will do treadmill training only, 3 times per week, least 8 weeks.

Group Type: ACTIVE_COMPARATOR

Treadmill training

Intervention Type: OTHER

Participants in control group will do treadmill training only

Interventions

Dual-task training

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

Intervention Type: OTHER

Treadmill training

Participants in control group will do treadmill training only

Intervention Type: OTHER

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Yang Ming Chiao Tung University

OTHER

Sponsor Role: lead

Responsible Party

Yea-Ru Yang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

National Yang-Ming university

Taipei, , Taiwan

Countries

Taiwan

References

Zhou JH, Wang RY, Liu YT, Cheng SJ, Liu HH, Yang YR. Effects of dual-task training on gait variability in individuals with Parkinson's disease: A randomized controlled trial. J Sci Med Sport. 2025 Jun 20:S1440-2440(25)00187-2. doi: 10.1016/j.jsams.2025.06.009. Online ahead of print.

Reference Type: DERIVED

PMID: 40610273 (View on PubMed)

Other Identifiers

17MMHIS193

Identifier Type: -

Identifier Source: org_study_id