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临床试验/NCT07500662
NCT07500662已完成不适用

The Effect of Ankle Foot Orthosis Influences the Prefrontal Load in Stroke Patients During Dual Task Walking

National Cheng-Kung University Hospital1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2024年10月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
26
试验地点
1
主要终点
Correct response rate

研究概览

简要总结

The goal of this clinical trial is to learn the effect of carbon fiber ankle foot rothosis (AFO) on dual-task walking perfromance and cognitive load for stroke patients.

The main questions it aims to answer are:

Does wearing carbon fiber AFO can improve gait and secondary task during dual task walking for individual with stroke ? Does wearing carbon fiber AFO can reduce the prefrontal load during dual task walking for individuals with stroke?

Researchers will compare gait, concurrent task performance, and FNIRs activation over prefrontal area under different test conditions (with/without AFO, single walk, cognitive dual walk, motor dual walk)

Participants will:

execute all different conditions repeatedly in a randomized order. require to visit the lab once, about 2 hours period to complete the whole experimental protocol.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

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

入选标准

  • age over 18 years old
  • diagnosed with stroke hemoplegia
  • Mini Mental State Examination (MMSE) equal or over 24
  • able to walk independently for 15 meters without any assistive device
  • able to follow instruction

排除标准

  • aphasia that could not comprehend or verbally response
  • orthopedic disease of lower extremity caused discomft during walking
  • neurological disease besides stroke

结局指标

主要结局

Correct response rate

时间窗: a single experimental session (Day 1)

Represent the correct response rate of concurrent cognitive performance

walking speed

时间窗: a single experimental session (Day 1)

calculated over a 13-m walking pathway (m/s)

Stride time

时间窗: a single experimental session (Day 1)

calculated over a 13-m walking pathway (s)

Step length

时间窗: a single experimental session (Day 1)

calculated over a 13-m walking pathway. (m)

Reaction time

时间窗: a single experimental session (Day 1)

time required to response during concurrent cognitive test (s)

Sway size of holding tray

时间窗: a single experimental session (Day 1)

The amount of sway size of holding tray during motor dual walk condition

Functional near-infrared spectroscopy (fNIRS)

时间窗: a single experimental session (Day 1)

oxygenated hemoglobin (HbO) concentration alternation over prefrontal area

次要结局

未报告次要终点

研究者

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

Yi-Ying Tsai

Assisitant Professor

National Cheng-Kung University Hospital

研究点 (1)

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