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临床试验/NCT03528148
NCT03528148Unknown不适用

China Medical University Hospital Asia University Hospital

China Medical University Hospital2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2018年8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
50
试验地点
2
主要终点
Gait

研究概览

简要总结

To investigate the effects of elliptical cross bike exercises combine conventional physical therapy on gait, postural control, balance, muscle tone, spasticity, quality of life, motor functioning, functional activity, and ADL in post stroke patients.

详细描述

In a single-blind, randomized controlled intervention, patients were randomly assigned to an active cycling group (ACG, n=25) five times a week combine with conventional al physical therapy or a control group (CG, n=25) with conventional physical therapy 3 weeks of training in the center.

All outcome measures were administered at the beginning of the study, at the end of the 1st, 2nd, and 3rd week.

All participants will be divided two groups. One group will be experiment with conventional physical therapy as control group (CG), the other group will active cycling as active cycling group (ACG) with elliptical Cross Trainer & Exercise Bike after conventional physical therapy.

Baseline assessment of muscle tone by Myoton-3, Modified Ashworth Scale used as a simple measure of spasticity; Barthel Index scale for performance in activities of daily living; Berg Balance Scale to measure balance; the upper and lower limb subscale of the Fugl-Meyer assessment for motor function of extremities; and BTS G-WALK was used to measure gait parameters. The data will be collect before session.

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 (Participant)

入排标准

性别
All
接受健康志愿者

入选标准

  • First-ever stroke (World Health Organization ,1978).
  • Joint mobility ranges of lower extremity that would not preclude pedaling(Ambrosini, Ferrante et al. 2011).
  • Unilateral hemiplegia.
  • Able to carry out simple instructions.
  • Able to sit independent at least 20 minutes and pedal an elliptical cross bike.

排除标准

  • Neurologic disorders with impaired functionality existing pre-stroke.
  • Patients could not follow instructions.
  • Cardiovascular disease or other risk factor which precluded participation in aerobic exercise.
  • Peripheral neuropathy that could potentially interfere with this study.

研究组 & 干预措施

active cycling group

Experimental

effect of combine cycling and conventional physical therapy in quality of life, functional activity and ADL, postural control, balance, muscle tone, spasticity, motor functioning, gait of stroke patients.

干预措施: cycling (Behavioral)

active cycling group

Experimental

effect of combine cycling and conventional physical therapy in quality of life, functional activity and ADL, postural control, balance, muscle tone, spasticity, motor functioning, gait of stroke patients.

干预措施: Physical therapy (Behavioral)

control group

Active Comparator

effect of combine conventional physical therapy in quality of life, functional activity and ADL, postural control, balance, muscle tone, spasticity, motor functioning, gait of stroke patients.

干预措施: Physical therapy (Behavioral)

结局指标

主要结局

Gait

时间窗: 3 weeks

Subjects were asked to walk at a self-selected speed using walking aids if necessary with 10 m. BTS G-WALK was used to measure characterized of the hemiparetic gait such as speed, cadence and step length of the stroke patients

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

Li-Wei Chou

Attending physician,rehabilitation department

China Medical University Hospital

研究点 (2)

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