Upper Limbs Intervention in Multiple Sclerosis
2016年10月30日 更新者：Marie Carmen Valenza、Universidad de Granada
Intervention Focused on Lower Limbs and Functionality in Patients With Multiple Sclerosis
Multiple sclerosis is a chronic and highly disabling disorder with considerable social impact and economic consequences.
It is caused by damage to the myelin sheath, the protective covering that surrounds nerve cells.
Different areas are affected, including manual dexterity, strength, coordination and function.
The objective of this study is to evaluate the improvement in these variables in patients with multiple sclerosis after a 8-weeks intervention focused on upper limbs.
研究概览
详细说明
The total estimated prevalence rate of multiple sclerosis has been reported to be 83 per 100 000 for the past three decades. It is also higher in northern countries and between females with a male ratio around 2.0. The highest prevalence rates have been estimated for the age group 35-64 years. The estimated European mean annual Multiple Sclerosis incidence rate is 4.3 cases per 100 000.
Multiple sclerosis can cause a variety of symptoms: hypoesthesia, muscle weakness, abnormal muscle spasms, or difficulty moving; difficulties with coordination and balance; dysarthria, dysphagia, visual problems fatigue and acute or chronic pain syndromes, bladder and bowel difficulties,cognitive impairment, or emotional symptomatology. The investigators focus on the benefits of an intervention on dexterity, strength, coordination and functionality.
研究类型
介入性
注册 (实际的)
37
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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Granada、西班牙、18071
- Faculty of Health Sciences
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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:
- Patients diagnosed with multiple sclerosis.
- Subjects who can complete the assessment battery of tests at the beginning and at the end of the study
Exclusion Criteria:
- Auditive and visual disturbances.
- Cognitive problems.
- Psychiatric pathology.
- Sensorial disturbances.
- Traumatic pathology of the hand.
- Concomitant neurological conditions
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：单组作业
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Experimental group
The patients included in this group will receive an intensive intervention based on upper limbs intervention with exercises added to the usual treatment they receive.
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An 8-week intervention with different exercises will be performed.
This intervention will focus on upper limbs.
The exercises will include plaster of resistance, elastic bands and other exercises.
其他名称：
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有源比较器：Control group
Patients with multiple sclerosis not included in the intensive intervention.
They receive the usual treatment of occupational and physical therapy.
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Occupational therapy and physiotherapy, twice a week, as usual.
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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Changes in manual dexterity
大体时间：baseline, 8 weeks
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Changes from baseline to postintervention in manual dexterity assessed by the Purdue Pegboard test and coin rotation task.
The Purdue pegboard test is a timed physical test used to measure manual dexterity.
Test subjects are asked to place small pins into holes in the pegboard using a specific hand and following a specific process.
The coin rotation task consists of rotate the coin during 10 seconds.
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baseline, 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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Changes in apraxia
大体时间：baseline, 8 weeks
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Changes in apraxia from baseline to postintervention is going to be measured using the Apraxia Screen of Tulia.
This is a screening test of upper limbs apraxia.
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baseline, 8 weeks
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Changes in grip strength
大体时间：baseline, 8 weeks
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The changes in the grip strength will be measured using a Jamar dynamometer with a standard protocol allowing three attempts on each side.
During each measurement, patients were sitting with their shoulder adducted and elbow flexed to 90°.
The maximum value achieved from all six attempts was used in analyses.
kg/cm2.
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baseline, 8 weeks
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Change in fatigue
大体时间：baseline, 8 weeks
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The fatigue change is going to be measured using the Fatigue Severity Scale, a 9-item scale focus on the severity of fatigue and how much it affects the person's activities and lifestyle in the patients.
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baseline, 8 weeks
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Upper limb functioning
大体时间：baseline, 8 weeks
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The upper limb functioning is going to be measured with the Action Research Arm Test, it is a 19 item measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement).
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baseline, 8 weeks
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Pinch strength
大体时间：baseline, 8 weeks
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Pinch strength is going to be measured using a pinch dynamometer.
The participants were asked to perform three repetitions on each side with five seconds rest provided between the measures.
This was performed using the alternating-hands method, which allows rest between repetitions as the examiner records information and provides instructions for the alternate hand.
Three pinchs were evaluated: lateral, distal and tripod pinch
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baseline, 8 weeks
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Tapping speed
大体时间：baseline, 8 weeks
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The tapping speed will be measured with the finger tapping test.
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baseline, 8 weeks
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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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Quality of life
大体时间：Baseline, 8 weeks
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Quality of life is going to be measured using a self-reported questionnaire, the short-form Health Survey, SF-36
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Baseline, 8 weeks
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Goals achievement
大体时间：baseline, 8 weeks
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The achievement of the goals of the intervention will be measured with the Goal Attainment Scale, a method of scoring the extent to which patient's individual goals are achieved in the course of intervention.
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baseline, 8 weeks
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Functionality
大体时间：baseline, 8 weeks
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Functionality will be measured with the Functional Independence Measure, a questionnaire.
This is the most widely accepted functional assessment measure in use in the rehabilitation community
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baseline, 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。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
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
2014年1月1日
初级完成 (实际的)
2015年8月1日
研究完成 (实际的)
2016年2月1日
研究注册日期
首次提交
2014年1月26日
首先提交符合 QC 标准的
2014年1月26日
首次发布 (估计)
2014年1月28日
研究记录更新
最后更新发布 (估计)
2016年11月1日
上次提交的符合 QC 标准的更新
2016年10月30日
最后验证
2016年10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.