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临床试验/NCT06588439
NCT06588439招募中不适用

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

National Yang Ming Chiao Tung University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年3月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
2
主要终点
Gait variability

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

Gait variability

时间窗: 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

时间窗: Before and after 8 weeks of intervention, as well as 4 weeks after intervention

Using GAITRite system to measure gait speed

Step length

时间窗: Before and after 8 weeks of intervention, as well as 4 weeks after intervention

Using GAITRite system to measure step length

Step width

时间窗: Before and after 8 weeks of intervention, as well as 4 weeks after intervention

Using GAITRite system to measure step width

Single support time

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: Before and after 8 weeks of intervention, as well as 4 weeks after intervention

Behavioral test during measuring electroencephalography.

Trail making test

时间窗: 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.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yea-Ru Yang

Professor

National Yang Ming Chiao Tung University

研究点 (2)

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