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临床试验/NCT04668573
NCT04668573已完成不适用

Turning Dysfunction After Stroke And Its Association To Trunk Control: Underlying Mechanisms And Training Effects

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2020年7月13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
42
试验地点
1
主要终点
Change from Baseline in turning duration at Week 12

研究概览

简要总结

The study aims to investigate the 1) differences between stroke patients and healthy controls in time, steps, angular velocity, stepping patterns, electromyographic responses during turning, and the association of turning to trunk control and motor function after stroke; 2) the effectiveness of trunk training on turning performance, trunk control and motor function in stroke patients.

详细描述

This study has two parts. The first part is a cross-sectional observatory study.Eligible stroke and healthy subjects are asked their demographic data and assessed for turning performance (stepping patterns and electromyography data of trunk muscles), trunk control (muscle strength, active range of motion, muscle mass and motor control in trunk) and motor function (recovery of extremities and balance function). The second part is a randomized controlled trial. Stroke participants are randomly allocated into trunk exercise and control groups. Trunk exercise group receives trunk exercise including trunk muscles stretching, trunk muscles strengthening, and task-related trunk control training for 30 minutes per session, twice a week for 12 weeks while control group remains their regular activities. Turning performance, trunk control and motor function are evaluated before and after training 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 (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

  • age between 20 and 80 years old
  • survivors of a single and unilateral stroke with hemiparesis experienced at least 6 months prior to their participation in the study
  • able to walk independently over a distance of 10 m without walking aids or orthoses
  • able to provide informed consent and follow instructions.

排除标准

  • having additional musculoskeletal conditions or comorbid disabilities that could affect the assessment
  • having cognitive problems with a Mini-Mental State Examination score less than 24 or aphasia that could prevent subjects from following instructions.

结局指标

主要结局

Change from Baseline in turning duration at Week 12

时间窗: Baseline and Week 12

Turning duration (s) was recorded during turning 360-degree in place using APDM Opal wireless sensors. Longer duration represents poorer turning performance.

Change from Baseline in turning angular velocity at Week 12

时间窗: Baseline and Week 12

Angular velocity (m/s2) was recorded during turning 360-degree in place using APDM Opal wireless sensors. Slower angular velocity represents instability during turning.

Change from Baseline in trunk muscles electromyography during turning at Week 12

时间窗: Baseline and Week 12

Muscle activation patterns (amplitude, % reference voluntary contraction) are observed in bilateral External abdominal oblique (EO) and erector spinae (ES) through an electromyographic analysis. Greater muscle amplitude represents greater muscle contraction.

次要结局

  • Change from Baseline in Trunk Impairment Scale at Week 12(Baseline and Week 12)
  • Change from Baseline in trunk range of motion at Week 12(Baseline and Week 12)
  • Change from Baseline in trunk muscles strength at Week 12(Baseline and Week 12)

研究者

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

Pei Jung Liang

Principal Investigator

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

研究点 (1)

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