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临床试验/NCT06504836
NCT06504836招募中不适用

Effects of Kinematic Biofeedback on Gait Quality in People With Stroke

National Yang Ming Chiao Tung University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年10月1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
40
试验地点
2
主要终点
Gait symmetry

研究概览

简要总结

Walking disorder is the most common and concerning issue for individuals with stroke. Previous studies have often used improvements in walking speed and distance as reference indicators for the advancement of gait performance in individuals with stroke. However, for individuals with chronic stroke, considering gait symmetry and variability to enhance gait quality as the primary intervention target may be more crucial. According to a literature review, it can be inferred that the application of biofeedback to detect gait quality may be an effective approach to improve gait symmetry and variability in individuals with stroke. However, there is still insufficient research evidence on this issue. Therefore, this study aims to investigate the effects of a kinematic biofeedback device system, which detects hip joint angles, on gait quality in individuals with chronic stroke.

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
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • First stroke
  • Stroke onset time ≥ 6 months
  • Functional Ambulation Category ≥3
  • Passive range of motion of affected hip extension is at least 10 degrees
  • Mini-Mental State Measurement score ≥ 24 points

排除标准

  • Modified Ashworth Scale of affected ankle plantar flexors ≥ 2
  • Muscle strength of affected ankle plantar flexors via Manual Muscle Testing ≤ 1
  • Uncorrected auditory impairment
  • Severe cardiovascular disease or uncontrolled hypertension
  • Other orthopedic diseases that may affect walking ability
  • Other neurological disease except stroke

结局指标

主要结局

Gait symmetry

时间窗: 1 day

Using GAITRite system to measure the symmetry of spatiotemporal parameters, including step length, step width, single support time, and double support time. Calculate the gait symmetry using following formula: Gait symmetry = affected side/ unaffected side.

Gait variability

时间窗: 1 day

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%

次要结局

  • Propulsive force(1 day)

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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