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Clinical Trials/NCT06588439
NCT06588439
Recruiting
Not Applicable

Cognitive-motor Training on Brain Activity, Cognitive Function, and Walking Ability in People With Parkinson Disease

National Yang Ming Chiao Tung University1 site in 1 country50 target enrollmentMarch 15, 2025

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Parkinson Disease
Sponsor
National Yang Ming Chiao Tung University
Enrollment
50
Locations
1
Primary Endpoint
Gait variability
Status
Recruiting
Last Updated
10 months ago

Overview

Brief Summary

Literature reviews showed the cognitive-motor training that combines cognitive tasks may enhance cognitive functions more effectively than individual interventions. Stepping-based cognitive-motor training has been shown to improve cognitive functions, balance, and gait performance in older adults. However, there is insufficient research evidence on the impact and correlation of this training mode on the walking ability, executive functions, and brain activity changes in people with PD. Therefore, this study is designed to investigate the effects of stepping-based cognitive-motor training on the walking ability, executive functions, and brain activity in people with PD.

Registry
clinicaltrials.gov
Start Date
March 15, 2025
End Date
August 31, 2027
Last Updated
10 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Yea-Ru Yang

Professor

National Yang Ming Chiao Tung University

Eligibility Criteria

Inclusion Criteria

  • Diagnoses of idiopathic Parkinson disease
  • Stable dopaminergic medicine ≥ 2 weeks
  • Able to walk 10 meters without aid
  • Mini-Mental Status Examination ≥ 24 points
  • No uncorrected visual or auditory disorders
  • Education at least junior high school
  • No other disease may affect balance

Exclusion Criteria

  • Other medical diagnoses of neurological, musculoskeletal, or cardiopulmonary disorders
  • History of brain surgery (e.g. deep brain stimulation)

Outcomes

Primary Outcomes

Gait variability

Time Frame: Before and after 8 weeks of intervention, as well as 4 weeks after intervention

Using GAITRite system to measure the coefficient of variation (CV). The mean and standard deviation will be used to calculate the coefficient of variation (CV). CV = standard deviation / mean \* 100%

Gait speed

Time Frame: Before and after 8 weeks of intervention, as well as 4 weeks after intervention

Using GAITRite system to measure gait speed

Step length

Time Frame: Before and after 8 weeks of intervention, as well as 4 weeks after intervention

Using GAITRite system to measure step length

Step width

Time Frame: Before and after 8 weeks of intervention, as well as 4 weeks after intervention

Using GAITRite system to measure step width

Single support time

Time Frame: Before and after 8 weeks of intervention, as well as 4 weeks after intervention

Using GAITRite system to measure single support time

Double support time

Time Frame: Before and after 8 weeks of intervention, as well as 4 weeks after intervention

Using GAITRite system to measure double support time

Frontal Assessment Battery

Time Frame: Before and after 8 weeks of intervention, as well as 4 weeks after intervention

The score ranged from 0 to 18. Higher scores show better executive function.

Stroop color and word test

Time Frame: Before and after 8 weeks of intervention, as well as 4 weeks after intervention

Record numbers of corrected color words which the subject responds within 45 sec.

Digit span test

Time Frame: Before and after 8 weeks of intervention, as well as 4 weeks after intervention

Digit span test contain forward and backward part. Scores of forward digit span ranges from 0 to 16. Score of backward digit span ranges from 0 to 14. Higher scores indicate better executive function.

Event-related potential - N2

Time Frame: Before and after 8 weeks of intervention, as well as 4 weeks after intervention

Measure event-related potential through electroencephalography under single-task and dual-task paradigm.

Event-related potential - P300

Time Frame: Before and after 8 weeks of intervention, as well as 4 weeks after intervention

Measure event-related potential through electroencephalography under single-task and dual-task paradigm.

Go/Nogo test

Time Frame: Before and after 8 weeks of intervention, as well as 4 weeks after intervention

Behavioral test during measuring electroencephalography.

Trail making test

Time Frame: Before and after 8 weeks of intervention, as well as 4 weeks after intervention

Trail making test contain part A and part B. Faster completing the test indicates better executive function.

Secondary Outcomes

  • Mini-Balance Evaluation Systems Test(Before and after 8 weeks of intervention, as well as 4 weeks after intervention)
  • Montreal Cognitive Assessment(Before and after 8 weeks of intervention, as well as 4 weeks after intervention)
  • Timed up and go test(Before and after 8 weeks of intervention, as well as 4 weeks after intervention)
  • Parkinson Disease Questionnaire(Before and after 8 weeks of intervention, as well as 4 weeks after intervention)

Study Sites (1)

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