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临床试验/NCT06395142
NCT06395142已完成不适用

Changes of Plantar Pressure and Electroencephalographic Signals During Pedal Walking and Vision-deprivation Walking in Stroke Patients.

Geriatric Hospital of Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
phase-amplitude coupling

研究概览

简要总结

Complex task training may be more effective than simple task training in promoting functional recovery and brain restructuring in stroke participants. The researchers intend to investigate the real-time changes in plantar pressure and electroencephalographic signals in stroke participants during two complex tasks: pedal walking and visual-deprivation walking. The research hypothesis is that pedal walking and visual-deprivation walking can improve the difference of plantar pressure between the affected and unaffected lower limbs of stroke participants, and cause corresponding electroencephalographic changes.

详细描述

Stroke participants perform the following tasks after wearing a plantar pressure device and a 32-lead electroencephalographic cap. First, stroke participants walk on the pedal on the lower limbs of the affected side. Then the researchers cover the participants' eyes with an eye mask, the participants perform the task of visual-deprivation walking. Finally, the participants walk on a flat surface. Each walking task lasts for 60 seconds. The participants can rest for 3-5 minutes between tasks.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • MRI or CT diagnosis of the first stroke onset;
  • The onset of the stroke occurred more than 30 days;
  • Safely walk 50 meters without assistance.

排除标准

  • Cerebellar injury;
  • Brain stem injury;
  • Visual impairment.

结局指标

主要结局

phase-amplitude coupling

时间窗: Real-time monitoring of electroencephalography data will occur while participants are walking. The Time Frame for data collection will encompass the entire duration of each participant's walking session, which lasts for 60 seconds.

Phase-amplitude coupling is a type of cross-phase coupling that represents the coupling between the phase of slow oscillations and the amplitude of fast oscillations.

phase-phase coupling

时间窗: Real-time monitoring of electroencephalography data will occur while participants are walking. The Time Frame for data collection will encompass the entire duration of each participant's walking session, which lasts for 60 seconds.

Phase-phase coupling is a special form of cross-phase coupling that represents the coupling between the phases of slow and fast oscillations, which can occur even when the coupling is very weak.

Amplitude-amplitude coupling

时间窗: Real-time monitoring of electroencephalography data will occur while participants are walking. The Time Frame for data collection will encompass the entire duration of each participant's walking session, which lasts for 60 seconds.

Amplitude-amplitude coupling is a form of cross-phase coupling that represents the coupling between the amplitudes of slow oscillations and fast oscillations .

weight Phase Lag Index

时间窗: Real-time monitoring of electroencephalography data will occur while participants are walking. The Time Frame for data collection will encompass the entire duration of each participant's walking session, which lasts for 60 seconds.

The weight phase lag index is an index of brain functional connectivity, can continuously measure the connectivity of the coupling of neural oscillatory activity.

relative power

时间窗: Real-time monitoring of electroencephalography data will occur while participants are walking. The Time Frame for data collection will encompass the entire duration of each participant's walking session, which lasts for 60 seconds.

Relative power reflects the frequency domain changes of electroencephalogram.

peak pressure

时间窗: Through study completion, an average of 2 months.

Peak pressure reflects the maximum pressure on the entire sole of the foot.

phase-frequency coupling

时间窗: Real-time monitoring of electroencephalography data will occur while participants are walking. The Time Frame for data collection will encompass the entire duration of each participant's walking session, which lasts for 60 seconds.

Phase-frequency coupling is a generic form of the cross-frequency coupling model, representing the coupling between the slow oscillations phase and the fast oscillations frequency.

次要结局

未报告次要终点

研究者

发起方
Geriatric Hospital of Nanjing Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jing Zhao

Principal Investigator

Geriatric Hospital of Nanjing Medical University

研究点 (1)

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