跳至主要内容
临床试验/NCT03183635
NCT03183635已完成不适用

A Randomized Controlled Trial of Rapid Movement Therapy With Real-time Feedback to Improve Balance Recovery for Fall Prevention After Stroke

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2017年6月19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
30
试验地点
1
主要终点
Timed Up and Go (TUG)

研究概览

简要总结

Stroke survivors have higher risks of falling compared to other healthy non-stroke adults. Stroke patients' balance can be trained by Kinect-based training that enable user friendly and interactive training.

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
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • have single stroke with onset >1 year,
  • have unilateral paresis,
  • are 50 years of age or older,
  • able to stand without aid for at least 15min,
  • have moderate level of motor impairment in the affective upper limb, i.e. 15≤ Fugl-Meyer Assessment for upper-extremity(FMA-UE) ≤ 45,
  • have some level of deficit in balance control, i.e. Berg Balance Scale(BBS)< 52/56,
  • have a minimum Snellen visual acuity of 20/40 with/without spectacles,
  • have a minimum Mini-Mental-Status-Examination score of 22/30, and
  • have to be able to follow the training procedures.

排除标准

  • enrolled in other rehabilitation program in the study duration,
  • have other neurological conditions in addition to stroke (e.g. Parkinson's disease),
  • have unstable cardiovascular disease (e.g. history of heart disease, or poorly controlled hypertension, i.e. blood pressure >160mmHg/100mmHg), or
  • have other serious diseases or conditions (e.g. osteoporosis, recent joint replacement surgery, amputation) that preclude them from participating in the study.

结局指标

主要结局

Timed Up and Go (TUG)

时间窗: 3-month follow-up

It is used to assess mobility, balance, walking ability, and fall risk in older adults

Berg Balance Scale (BBS)

时间窗: 3-month follow-up

A 14-item objective measure designed to assess static balance and fall risk in adult populations

次要结局

  • Fugl-Meyer Assessment (FMA) of Motor Recovery after Stroke(3-month follow-up)
  • Barthel Index of Activities of Daily Living(3-month follow-up)
  • Activities-specific Balance Confidence (ABC) Scale(3-month follow-up)
  • Electromyography (EMG)(3-month follow-up)
  • "lean-and-release" postural system(3-month follow-up)

研究者

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

Raymond KY Tong

Professor

Chinese University of Hong Kong

研究点 (1)

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