Turning Dysfunction After Stroke: Assessment and Intervention
2020年12月13日 更新者：Pei Jung Liang、Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Turning Dysfunction After Stroke And Its Association To Trunk Control: Underlying Mechanisms And Training Effects
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.
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
42
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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New Taipei City、台湾
- Taipei Tzu Chi Hospital
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
20年 至 80年 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Trunk exercise group
Participants received trunk exercise for 30 minutes per session, twice a week for 12 weeks.
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Trunk exercise includes trunk muscles stretching, trunk muscles strengthening, and task-related trunk control training for 30 minutes per session, twice a week for 12 weeks.
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无干预：Control group
Participants remained their regular activities.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change from Baseline in turning duration at Week 12
大体时间：Baseline and Week 12
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Turning duration (s) was recorded during turning 360-degree in place using APDM Opal wireless sensors.
Longer duration represents poorer turning performance.
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Baseline and Week 12
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Change from Baseline in turning angular velocity at Week 12
大体时间：Baseline and Week 12
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Angular velocity (m/s2) was recorded during turning 360-degree in place using APDM Opal wireless sensors.
Slower angular velocity represents instability during turning.
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Baseline and Week 12
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Change from Baseline in trunk muscles electromyography during turning at Week 12
大体时间：Baseline and Week 12
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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.
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Baseline and Week 12
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change from Baseline in trunk range of motion at Week 12
大体时间：Baseline and Week 12
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The trunk range of motion (ROM) was measured using a tape measure in sitting position.
The spinous processes at C7 and S1 served as landmarks for placement of the tape and measurement for trunk flexion and extension ROM.
The length between iliac crest and contralateral acromion of scapula was measured for trunk rotation ROM while the distance between the tip of the middle finger and the floor for trunk lateral flexion ROM.
The difference between tape measures in starting and ending positions was calculated for all trunk movement directions.
Greater value of trunk flexion and rotation but smaller value of trunk extension and lateral flexion represents better trunk ROM.
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Baseline and Week 12
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Change from Baseline in trunk muscles strength at Week 12
大体时间：Baseline and Week 12
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Trunk flexors, extensors, rotators, and lateral flexors strength were measured using a MicroFET3 dynamometer.
Participants were asked to generate the maximum trunk flexion, extension, rotation bilaterally and lateral flexion bilaterally for a period of 6 seconds each.
Resistance was applied using the dynamometer to obtain the value of each trunk muscle (kg).
Greater value represents greater muscle strength.
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Baseline and Week 12
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Change from Baseline in Trunk Impairment Scale at Week 12
大体时间：Baseline and Week 12
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Trunk control was assessed by the Trunk Impairment Scale (TIS) which has good inter-rater reliability with intra-class coefficient 0.85-0.99 and internal consistency with Cronbach's α 0.65-0.89.
The TIS evaluates static and dynamic sitting balance and trunk coordination in a sitting position.
On the static and dynamic sitting balance and coordination subscales the maximal scores that can be attained are 7, 10 and 6 points.
The total score for TIS ranges between 0 for a minimal performance to 23 for a perfect performance.
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Baseline and Week 12
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change from Baseline in Modified Clinical Test of Sensory Integration and Balance at Week 12
大体时间：Baseline and Week 12
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Modified Clinical Test of Sensory Integration and Balance (mCTSIB) is designed to assess how well an older adult is using sensory inputs when one or more sensory systems are compromised.
The postural sway was measured in 4 sensory conditions through visual and proprioceptive manipulation using APDM Opal wireless sensors.
The greater postural sway represents the poorer balance.
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Baseline and Week 12
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Change from Baseline in Berg Balance Scale at Week 12
大体时间：Baseline and Week 12
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The Berg balance scale (BBS) is used to objectively determine a participant's ability to safely balance during a series of predetermined tasks.
It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function.
The total score is 56.
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Baseline and Week 12
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Change from Baseline in Timed Up and Go test at Week 12
大体时间：Baseline and Week 12
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Function mobility was assessed by the Timed Up and Go (TUG) test.
Participants were instructed to stand up from a chair, walk 3 meters, turn around, and walk back to the chair sit down.
Time to complete the task was recorded.
The more time taken is representative of the lower level of functional mobility.
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Baseline and Week 12
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Pei-Jung Liang、Taichung Tzu Chi Hospital
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2020年7月13日
初级完成 (实际的)
2020年10月31日
研究完成 (实际的)
2020年10月31日
研究注册日期
首次提交
2020年12月8日
首先提交符合 QC 标准的
2020年12月13日
首次发布 (实际的)
2020年12月16日
研究记录更新
最后更新发布 (实际的)
2020年12月16日
上次提交的符合 QC 标准的更新
2020年12月13日
最后验证
2020年12月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.