Effects of Training in a Virtual Environment in Chronic Stroke Patients
2018年11月1日 更新者：University of Sao Paulo General Hospital
Effects of Training in a Virtual Environment on the Motor Function,Postural Control and Quality of Life in Chronic Stroke Patients: A Randomized Controlled Trial
The objective of this work will be compare the effects of two balance training programs, one Nintendo Wii Fit-based and the other traditionally-based without the use of a gaming system, on the (1) motor function, (2) cognition, (3) balance and (4) gait in chronic stroke patients.
It is a prospective, single blinded, randomized clinical trial performed at Center of Research of the courses of Speech Therapy, Physical Therapy and Occupational Therapy of São Paulo University.
Forty patients will be randomly assigned in control and experimental group, 20 each one.
研究概览
详细说明
The objective of this work is to compare the effects of two balance training programs, one Nintendo Wii Fit-based and the other traditionally-based without the use of a gaming system, motor function, balance and quality of life in chronic stroke patients.
It is a prospective, single-blinded, randomized clinical trial performed at Center of Research of the courses of Speech Therapy, Physical Therapy and Occupational Therapy of São Paulo University.
Forty chronic stroke patients are randomly in control and experimental group, 20 each one.
Both groups conduct 14 training sessions, twice a week, for seven weeks.
Each session will consist a 30 minute-global-exercise series including stretching, muscle strength and axial mobility exercises.
After this, both groups will performed more 30 minutes of balance training: the control group will performed balance exercises without external cues, visual or auditory feedbacks or cognitive stimulations; the experimental group will performed the balance training with 8 Wii Fit games which stimulate motor and cognitive functions.
The main outcome measures will be: (1) the lower limb subscale of the Fugl-Meyer Assessment (FMA-LE); (2); Balance Evaluation Systems Test (BESTest);(3) the Stroke-Specific Quality of Life (SS-QOL); (4) 6- minute walk test (6MWT) and (5) The limits of stability (LOS).
研究类型
介入性
注册 (实际的)
40
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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São Paulo、巴西、05360-160
- Department of Physiotherapy, Communication Science & Disorders, Occupational Therapy, School of Medicine, University of São Paulo
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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
18年 至 65年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- hemiparetic status resulting from a single stroke at least 6 months earlier;
- the ability to walk 10 m independently with or without an assistive device;
- the absence of a musculoskeletal condition that could potentially affect the ability to walk safely;
- the absence of serious visual impairment or a hearing disorder;
- power of at least grade 3 in the hemiplegic lower extremity;
- able to understand and follow simple instructions.
Exclusion Criteria:
- a Montreal Cognitive Assessment (MoCA) score of < 20;
- severe dementia or aphasia;
- hemispatial neglect, ataxia or any other cerebellar symptom;
- inability to stand without minimal assist;
- Impaired vision
- Uncontrollable medical complications
- participation in other studies or rehabilitation programs
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：Virtual Reality Training
The virtual reality training will be done by experimental group with ten games of Nintendo Wii Fit.
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The participants of the study will be trained 8 balance games during 14 sessions
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有源比较器：Control group: Physical Therapy
The Control Group will be trained by conventional Physical Therapy exercises.
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Patients of the control group will be trained with balance exercises.
其他名称：
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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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The lower limb subscale of the Fugl-Meyer Assessment (FMA-LE)
大体时间：up to 2 months
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FMA-LE is a subscale measuring lower limb motor recovery.
It examines movement and coordination of the hip, knee, and ankle in the supine, sitting, and standing positions.
Each item is scored on a 3-point scale (0, cannot perform; 1, partially performs; 2, performs fully).
The score range is 0 to 34, with higher scores indicating better lower limb motor performance
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up to 2 months
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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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Balance Evaluation Systems Test (BESTest)
大体时间：Up 2 months
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Balance Evaluation Systems Test (BESTest) measures balance.
It includes 36 items that evaluate performance of 6 balance systems: biomechanical constraints, stability limits/verticality, anticipatory postural adjustments, postural responses, sensory orientation, and stability in gait.
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Up 2 months
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6-minute walk test
大体时间：Up to 2 months
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The 6MWT is a practical simple test.
This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes (the 6MWD).
The 6MWT has been used as a measure of functional status of patients.
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Up to 2 months
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Stroke specific quality of life scale
大体时间：Up to 2 months
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Stroke Specific Quality of Life Scale is a self-report assessment that includes 12 stroke specific subscales with 49 items.
The Stroke Specific Quality of Life Scale attempts to capture the domains of stroke specific QOL that are insufficiently assessed with generic QOL measures.
The 12 subscales, which are unidimensional, are Energy, Family Role, Language, Mobility, Mood, Personality, Self-Care, Social Roles, Thinking, Upper Extremity Function, Vision, and Work-Productivity.
Participants responded to each item on a 5-point scale.
Domain scores are the averages of the item scores, and the total score is the average of the domain scores.
All summary scores therefore range from 1 to 5. Higher scores indicate better function.
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Up to 2 months
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Limits of Stability
大体时间：Up to 2 months
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The Limits of Stability subtest quantifies the maximum distance a person can intentionally displace their center of pressure (COP) from start position of midline COP centered over the base of support to eight targets.
Location and movement of the COP was indicated by a cursor display projected on a screen in front of the subject.
As targets were highlighted, the subject was to move the COP cursor quickly and accurately as possible towards a target located on the Limits of Stability perimeter and hold position as close to the target as possible.
The parameters include COP movement velocity and directional control (% to target).
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Up to 2 months
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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：Tatiana P Oliveira, PhD student、University of Sao Paulo
- 首席研究员：Camila S Miranda, Ms Student、University of Sao Paulo
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)
2014年2月1日
初级完成 (实际的)
2017年6月1日
研究完成 (实际的)
2018年2月1日
研究注册日期
首次提交
2013年6月20日
首先提交符合 QC 标准的
2013年6月20日
首次发布 (估计)
2013年6月25日
研究记录更新
最后更新发布 (实际的)
2018年11月2日
上次提交的符合 QC 标准的更新
2018年11月1日
最后验证
2018年7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.