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临床试验/NCT06598891
NCT06598891招募中不适用

Effect of Combined PAS Balance Training on Individuals With PD

Chang Gung University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年10月9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
60
试验地点
2
主要终点
Motor Evoked Potentials (MEPs)

研究概览

简要总结

Gait initiation (GI) difficulty is a common problem in individuals with Parkinson's disease (PD), often linked to impaired anticipatory postural adjustments (APA). Currently, there are no targeted rehabilitation programs designed specifically for GI-related APA in PD patients. Research has shown that while motor learning deficits are common in PD, explicit learning is better preserved than implicit learning. Therefore, a GI-related APA training system using an explicit learning model could be particularly effective for this population.

During motor learning, long-term potentiation (LTP) increases the excitability of the primary motor cortex. Paired associative stimulation (PAS) has been demonstrated to induce LTP-like changes in the motor cortex, making it a potential priming method to enhance motor learning. However, the priming effect of PAS targeted at leg muscles and the motor cortex on motor learning related to GI-APA has not been previously studied.

The objectives of this study are:

  1. To investigate the effects of explicit and implicit training on GI-related APA.
  2. To evaluate the priming effect of PAS on GI-related APA training and the associated plasticity changes in the motor cortex.

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
None

入排标准

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

入选标准

  • Clinical diagnosis of Parkinson disease.

排除标准

  • Musculoskeletal injuries on legs
  • Osteoporosis.
  • Any peripheral or central nervous system injury or disease patients.

结局指标

主要结局

Motor Evoked Potentials (MEPs)

时间窗: Baseline, 4 weeks and 8 weeks

MEPs are the electrical responses recorded from muscles following stimulation of the motor cortex. They reflect the efficiency of neural transmission from the cortex to the muscle. Unit:millivolts (mV)

Balance Performance

时间窗: Baseline, 4 weeks and 8 weeks

Measured by the duration the stance or stand can be maintained. Unit:second(s)

COP Path Length in Balance Tasks

时间窗: Baseline, 4 weeks and 8 weeks

The total distance traveled by the COP over a specified period. Longer path lengths can indicate increased effort to maintain balance or greater instability.

COP Displacement in Balance Tasks

时间窗: Baseline, 4 weeks and 8 weeks

Measures of COP movement in the anterior-posterior (AP) and medial-lateral (ML) directions, offering insights into the directional tendencies of balance control. Unit:millimeter(mm)

Intracortical Facilitation (ICF)

时间窗: Baseline, 4 weeks and 8 weeks

ICF is measured by applying a pair of TMS pulses with a short interval (e.g., 8-15 ms) where the first (subthreshold) pulse is followed by a second (suprathreshold) pulse, leading to an increased amplitude of the MEP.

Intracortical Inhibition (ICI)

时间窗: Baseline, 4 weeks and 8 weeks

ICI is measured similarly to ICF but with a shorter inter-stimulus interval (e.g., 1-5 ms), resulting in a suppressed MEP amplitude. This suppression reflects inhibitory processes within the cortex.

Walking Speed

时间窗: Baseline, 4 weeks and 8 weeks

The time taken by participants to walk a standardized distance, typically expressed in centimeters per second (cm/s).

Step Length

时间窗: Baseline, 4 weeks and 8 weeks

The linear distance between the two ankles, typically expressed in centimeter(cm).

Step Time

时间窗: Baseline, 4 weeks and 8 weeks

The duration taken for one complete step, measuring from foot-off of one foot to the next foot-off of the same foot, usually expressed in seconds.

次要结局

  • COP Velocity in Balance Tasks(Baseline, 4 weeks and 8 weeks)
  • COP Area in Balance Tasks(Baseline, 4 weeks and 8 weeks)
  • Double Support Time(Baseline, 4 weeks and 8 weeks)
  • Single Support Time(Baseline, 4 weeks and 8 weeks)
  • Swing Time(Baseline, 4 weeks and 8 weeks)
  • Stance Time(Baseline, 4 weeks and 8 weeks)
  • Cadence(Baseline, 4 weeks and 8 weeks)

研究者

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

Ya-Ju Chang

Professor

Chang Gung University

研究点 (2)

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