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临床试验/NCT04974840
NCT04974840Unknown不适用

Effects of Thera-band Resisted Treadmill Training on Walking Ability in Chronic Stroke Patients

Sang-I Lin2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2021年9月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
80
试验地点
2
主要终点
Balance

研究概览

简要总结

The purpose of this study is to determine if treadmill training combined with thera-band resistance to body support and forward propulsion would be more effective than treadmill training alone in improving over-ground walking ability and reducing energy cost in chronic stroke patients. This study will also characterize the neuromuscular and kinematic strategies to adapt to resisted treadmill walking in non-impaired adults and stroke patients.

详细描述

This study includes chronic stroke patients who will be randomly assigned to treadmill training combined with thera-band or treadmill training alone group to receive 30 min per session, 2 sessions per week for 8 weeks walking training . Functional balance (Berg Balance Scale), gait characteristics during preferred and maximal speed level walking, and oxygen uptake during 5-minute bouts of treadmill walking will be assessed before and after training and at 2-month follow-up. Clinical sensorimotor function assessment, including hand grip strength, plantar sensitivity, stroke rehabilitation assessment of movement and Fugl-Meyer lower extremity motor scale will also be conducted for subject characterization.

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
None

入排标准

年龄范围
20 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • the diagnosis of first time unilateral stroke more than 6 months before
  • the ability to walk for at least 15 m without person assistance
  • apparent gait deficits upon visual inspection by a trained physical therapist or inability in community ambulation, i.e. walking speed < 0.8 m/s
  • resting blood pressure lower than 150/90 mmHg.

排除标准

  • older than 75 years
  • inability to follow the experimental instructions or procedures
  • any pain, inflammation, or other conditions that could affect walking
  • medically unstable.

结局指标

主要结局

Balance

时间窗: 8 weeks

Berg Balance scale Minimum scale = 0 Maximum scale = 56 Higher scores indicate better functional balance.

stride characteristics

时间窗: 8 weeks

Wearable movement sensors will be used to measure walking speed, stride length and time, and gait cycle. Ground reaction forces during walking. A force platform will be used to measure ground reaction forces and center of pressure.

Walking oxygen uptake

时间窗: 8 weeks

A Ultima Cordi 02 machine will be used to measure VO2 during 5-minute bouts of treadmill walking.

次要结局

未报告次要终点

研究者

发起方
Sang-I Lin
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Sang-I Lin

Professor

National Cheng Kung University

研究点 (2)

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