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临床试验/NCT03848624
NCT03848624Unknown不适用

CUHK Jockey Club HOPE 4 Care Programme - Interactive FES Cycling System

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2019年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
120
试验地点
1
主要终点
Fugl-Meyer Assessment for Lower-Extremity

研究概览

简要总结

The Hong Kong Jockey Club Charities Trust has supported CUHK to launch a three-year project 'CUHK Jockey Club HOPE4Care Programme' to implement four evidence-based advanced rehabilitation technologies in 40 local elderly day care centres and rehabilitation centres, to benefit the community.

Our research team had developed the "Interactive FES Cycling System" that can be used as tools for rehabilitation by individuals who have suffered from a stroke or elderly. The system can integrate both motor power and muscle power in order to facilitate an active rehabilitative exercise.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
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

  • Diagnosis of ischemic brain injury or intracerebral haemorrhage shown by magnetic resonance imaging or computed tomography after the onset of stroke;
  • Significant gait deficit (Functional Ambulatory Category, FAC<4 [person cannot walk independently]).

排除标准

  • Any additional medical or psychological condition that would affect their ability to comply with the study protocol, e.g., a significant orthopaedic or chronic pain condition, major post-stroke depression, epilepsy, artificial cardiac pacemaker / joint;
  • Severe hip, knee or ankle contracture that would preclude passive range of motion of the leg (MAS<3).

研究组 & 干预措施

Cycling Group

Experimental

Intention driven motor-assisted voluntary cycling with electrical stimulation

干预措施: Cycling Group (Device)

结局指标

主要结局

Fugl-Meyer Assessment for Lower-Extremity

时间窗: Three months after the last training session

Fugl-Meyer Assessment for Lower-Extremity (FMA-LE), consists of 34-level cumulative scoring system to examine lower-limb functions of hemiplegic stroke patients quantitatively through a set of lower-limb movement tasks in reflex, flexor/extensor synergy, volitional movement, coordination and speed (Fugl-Meyer, et al., 1975). All assessment items are either scoring "full", "partial", or "none" functionality in the affected side, which minimizes ceiling and floor effects. FMA-LE demonstrated high internal consistency and a reliable assessment tool for a group of 140 hemiplegic community dwelling patients (Park \& Choi, 2014).

次要结局

  • 6 Minute Walk Test(Three months after the last training session)
  • Timed 10-meter Walk Test(Three months after the last training session)
  • Berg Balance Scale(Three months after the last training session)
  • Modified Ashworth Scale(Three months after the last training session)
  • Functional Ambulation Category Test(Three months after the last training session)

研究者

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

Raymond KY Tong

Professor and Chairman

Chinese University of Hong Kong

研究点 (1)

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