跳至主要内容
临床试验/NCT06490276
NCT06490276招募中不适用

Effects of Biofeedback Gait Training on Gait Quality Post-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

Post-stroke gait dysfunction is characterized by reduced gait velocity and stride length, along with gait asymmetry and instability. Gait asymmetry and instability are considered as indicators for gait quality, which affect independence and quality of life in individual with stroke. Previous studies have suggested that gait biofeedback is a promising strategy for enhancing the efficacy of post-stroke gait training. However, there is insufficient evidence on the effects of kinematic biofeedback gait training on gait asymmetry and instability in individuals with stroke. Therefore, the purpose of this study is to investigate the effects of real-time kinematic gait biofeedback training on gait quality in individuals with 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: Change from baseline at 4 weeks after training and 4 weeks follow-up

Using GAITRite system to measure the symmetry of saptiotemporal parameters

Gait variability

时间窗: Change from baseline at 4 weeks after training and 4 weeks follow-up

Using GAITRite system to measure the coefficient of variation of saptiotemporal parameters

次要结局

  • Propulsive force(Change from baseline at 4 weeks after training and 4 weeks follow-up)
  • Stroke Impact Scale(Change from baseline at 4 weeks after training and 4 weeks follow-up)
  • Gait performance(Change from baseline at 4 weeks after training and 4 weeks follow-up)
  • Berg Balance Scale(Change from baseline at 4 weeks after training and 4 weeks follow-up)
  • Activities-specific Balance Confidence Scale(Change from baseline at 4 weeks after training and 4 weeks follow-up)
  • Taiwan Chinese version Falls Efficacy Scale(Change from baseline at 4 weeks after training and 4 weeks follow-up)
  • Frenchay Activities Index(Change from baseline at 4 weeks after training and 4 weeks follow-up)

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)

Loading locations...

相似试验