Dual Task Training in Parkinson's Disease
2019年11月15日 更新者：Çağrı Gülşen、Gazi University
Effect of Dual Task Training on Balance, Gait, Cognition and Neurotrophic Factors in Parkinson's Disease
The aim of study is to analyze the effects of dual task training on balance, gait, cognition and neurotrophic factors in Parkinson's disease.
研究概览
详细说明
20 patients diagnosed with Parkinson's disease will be randomly assigned to either intervention or control group.
And 10 healty subjects will be included to study in order to determine the reference values.The intervention group will be recieved cognitive and motor dual task training consisting of balance and walking activities 3 days a week for 8 weeks.
Control group will be recieved same balance and walking activities in single task condition 3 days a week for 8 weeks.
In order to evaluate the effects of the training, evaluations will be performed before and after the training period.
研究类型
介入性
注册 (预期的)
20
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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Ankara、火鸡、06560
- 招聘中
- Gazi University, Faculty of Health Sciences
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接触：
- Çağrı Gülşen
- 电话号码：05555874415
- 邮箱：fztcagri@gmail.com
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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
40年 及以上 (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:
- at least 40 years of age
- neurologist-diagnosed Parkinson's Disease
- Hoehn & Yahr (H&Y) stages 1 to 3
- 24 or more mini mental status examination score.
Exclusion Criteria:
- other neurologic disorder
- cardiovascular, inflammatory,vestibular or musculoskeletal problems that could prevent them to participate in an exercise program
- had deep brain stimulation history
- visual, auditory, orientational problems that could affect study results
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：干预组
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45 minutes of dual task training consisting of motor activities (walking, balance... etc.) with combination of cognitive activities (spelling words, image description, nomination, word generation, counting... etc.) at sime time.
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有源比较器：控制组
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45 minutes of single task training consisting of same motor activities (walking, balance... etc.)
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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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Balance-Postural Stability
大体时间：8 weeks
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Postural Stability will be evaluated with Biodex Biosway Portable Balance System (Biodex Medical Systems Inc., Shirley, New York).. Postural Stability test will performed on both feet and on the left and right foot separately.
Total stability index score will obtained as the test result.
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8 weeks
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Balance- Limits of Stability
大体时间：8 weeks
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Limits of Stability will be evaluated with Biodex Biosway Portable Balance System (Biodex Medical Systems Inc., Shirley, New York).
Limits of Stability test assesses how much the center of gravity is displaced on the support surface without losing balance during the standing position.
Total direction control score will obtained as the test result.
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8 weeks
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Balance- Modified Sensory Organization Tests
大体时间：8 weeks
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Modified Sensory Organization Tests will be evaluated Biodex Biosway Portable Balance System (Biodex Medical Systems Inc., Shirley, New York).
MSOT assesses the effects of somatosensory, visual and vestibular senses on postural control during the standing position.
It evaluates the sensory component of balance in two different visual conditions and on two different support surfaces; condition 1: eyes open-firm surface, condition 2: eyes closed-firm surface, condition 3: eyes open-foam surface and condition 4: eyes closed-foam surface.
Stability index scores will obtained as the test result.
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8 weeks
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Gait Speed
大体时间：8 weeks
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Gait speed will be evaluated by using the BTS-G Walk system and recorded as m/min.
It is a wireless system positioned on L5 vertebrae of the spine.
It allows a functional objective gait analysis to be performed.
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8 weeks
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Cadence
大体时间：8 weeks
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Cadence will be evaluated by using the BTS-G Walk system and recorded as strides/min.
It is a wireless system positioned on L5 vertebrae of the spine.
It allows a functional objective gait analysis to be performed.
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8 weeks
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Stride width
大体时间：8 weeks
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Stride width will be evaluated by using the BTS-G Walk system and recorded as meters.
It is a wireless system positioned on L5 vertebrae of the spine.
It allows a functional objective gait analysis to be performed.
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8 weeks
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Stride length
大体时间：8 weeks
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Stride length will be evaluated by using the BTS-G Walk system and recorded as meters.
It is a wireless system positioned on L5 vertebrae of the spine.
It allows a functional objective gait analysis to be performed.
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8 weeks
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Montreal Cognitive Assessment (MoCA)
大体时间：8 weeks
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Montreal Cognitive Assessment (MoCA) will be used in order to evaluate cognition.
It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation.It' score ranged from 0 to 30 and higher points indicates better cognitive outcomes.
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8 weeks
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Change in brain derived neurotrophic factor (BDNF) levels of serum
大体时间：8 weeks
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Brain derived neurotrophic factor (BDNF) levels of serum will be measured by using sandwich enzyme-linked immunosorbent assay (ELISA) kit.
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8 weeks
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Change in vascular endothelial growth factor (VEGF) levels of serum
大体时间：8 weeks
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Vascular endothelial growth factor (VEGF) levels of serum will be measured by using sandwich enzyme-linked immunosorbent assay (ELISA) kit.
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8 weeks
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Change in insulin like growth factor 1 (IGF-1) levels of serum
大体时间：8 weeks
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Insulin like growth factor 1 (IGF-1) levels of serum will be measured by using sandwich enzyme-linked immunosorbent assay (ELISA) kit.
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8 weeks
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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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Hoehn and Yahr Scale for level of physical disability in Parkinson's disease.
大体时间：8 weeks
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Hoehn and Yahr Scale is measures level of physical disability in Parkinson's disease and stages patients between level 1 level 5. Higher level indicates worse physical condition.
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8 weeks
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Unified Parkinson's Disease Rating Scale (UPDRS)
大体时间：8 weeks
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The Unified Parkinson's Disease Rating Scale (UPDRS) is a widely used measure of impairment and disability associated with Parkinson's Disease (PD) consisting of four sections: (1) Mentation, behavior, and mood; (2) Activities of daily living (ADLs); (3) Motor; and (4) Complications.Sections I through III are scored using a 5-point Likert-type scale (0 = no impairment; 4 = marked impairment).
Although individual sections are scored and reported independently, scores from sections I through III are also summed to provide a UPDRS Total score.
The UPDRS total score ranges between 0 and 199 points.
Higher points indicates worse outcome.
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8 weeks
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Berg Balance Scale (BBS)
大体时间：8 weeks
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Berg Balance Scale (BBS) is a scale that using for assess postural stability.
It ranges 0-56 with higher score indicates better stability.
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8 weeks
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One-legged Stance Test
大体时间：8 weeks
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The duration participant is able to maintain their balance on one leg up to will be recorded.
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8 weeks
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Timed Up and Go (TUG) test
大体时间：8 weeks
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Time in seconds a person needs to stand up from a chair, walk a distance of 3 meters, turn around a flag, come back and sit down again.
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8 weeks
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Activities-Specific Balance Confidence (ABC) Scale
大体时间：8 weeks
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Activities-specific Balance Confidence scale (ABC), to quantify the level of confidence in performing a specific task without losing balance or becoming unsteady.
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8 weeks
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Stroop Test
大体时间：8 weeks
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Stroop test will be used to test cognitive function.
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8 weeks
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Trail Making Test (TMT) Part A and B
大体时间：8 weeks
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The Trail Making Test is a measure of attention, speed and mental flexibility.
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8 weeks
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Short-Form 8-Item Parkinson's Disease Questionnaire (PDQ-8)
大体时间：8 weeks
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The short-form 8-item Parkinson's disease Questionnaire (PDQ-8) is the most commonly used scale measuring health related quality of life (HRQoL) in PD patients.
It includes 8 items, and each item has five options (never, occasionally, sometimes, often, always or cannot do at all).
The total score ranges from 0 to 32.
Higher scores indicates poorer quality of life.
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8 weeks
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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。
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)
2019年10月16日
初级完成 (预期的)
2021年3月30日
研究完成 (预期的)
2021年6月30日
研究注册日期
首次提交
2019年9月30日
首先提交符合 QC 标准的
2019年10月2日
首次发布 (实际的)
2019年10月4日
研究记录更新
最后更新发布 (实际的)
2019年11月18日
上次提交的符合 QC 标准的更新
2019年11月15日
最后验证
2019年11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.