Influence of Cognitive Function Software Therapy on the Improvement of Manual Skills in Multiple Sclerosis Patients
追踪信息 | |||
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首次提交日期 ICMJE | September 25, 2018 | ||
首次发布日期e ICMJE | October 2, 2018 | ||
最后更新发布日期 | October 2, 2018 | ||
预计研究开始日期 ICMJE | January 13, 2018 | ||
预计主要完成日期 | April 20, 2018 (主要结果测量的最终数据收集日期) | ||
目前主要观察指标 ICMJE |
Hand therapy using cognitive functions in patients with MS[ Time Frame: 3 months ] Three times a week the study group received the upper limb treatment by means of the cognitive function platform. They were expected to achieve 96 levels of visuo-motor coordination in 3 months or the treatment was to be terminated. After completing each task the patient would move on to a higher level of difficulty. Failure meant having to redo that particular task. One training session lasted 20 min., after which the patient could take a break. |
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原始主要观察测量 ICMJE | 与当前相同 | ||
目前的二级观察 ICMJE |
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描述性信息 | |||
简略标题 ICMJE | Influence of Cognitive Function Software Therapy on the Improvement of Manual Skills in Multiple Sclerosis Patients | ||
正式标题 ICMJE | Influence of Cognitive Function Software Therapy on the Improvement of Manual Skills in Multiple Sclerosis Patients | ||
简要概况 | Multiple Sclerosis (MS) is a chronic demyelinating disease of the central nervous system leading to the impairment of motor, visual and cognitive functions. A standardized rehabilitation of cognitive functions can be provided by a systematized treatment program devised to improve neurological patients' quality of life. The degree of difficulty of the computerized tasks was adapted to a patient's predispositions and modified once a desirable improvement in the practiced skill has reached. The aim of the study was to assess the influence of cognitive therapy by means of the cognitive software on manual dexterity in patients with multiple sclerosis. We also attempted to establish whether factors like age, sex and Expanded Disability Status Scale (EDSS) scores contribute to the outcomes of that therapy. All patients enrolled will have a documented history of MS disease prior to study enrollment. The EDSS scores varied between 1.5-4 (mean score 2.1). The Nine Hole Peg Test (NHPT), administered to all of the patients, was used to evaluate the subjects' manual dexterity. Having been administered the NHPT test the initial 86-patient group was reduced to a cohort of 40 subjects qualified for the study, who were subsequently randomly divided into two groups - the study and the control - each consisting of 20 subjects. Three times a week the study group received the upper limb treatment by means of the cognitive function platform. They were expected to achieve 96 levels of visuo-motor coordination in 3 months or the treatment was to be terminated. After completing each task the patient would move on to a higher level of difficulty. Failure meant having to redo that particular task. One training session lasted 20 min., after which the patient could take a break. Having completed the training each patient was administered the NHPT test again in view of assessing the efficiency of their upper limb. Due to progressive deterioration of health and other factors only 10 patients managed to complete the training. |
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详细说明 | |||
研究类型 ICMJE | Interventional | ||
研究阶段 | N/A | ||
研究设计 ICMJE | 分配: Randomized 干预模型: Factorial Assignment 干预模型描述: 盲法: Interventional 盲法描述: 主要目的: Treatment |
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适用条件 ICMJE | |||
干预项目 ICMJE |
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研究工具 |
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招募信息 | |||
招募状态 ICMJE | Terminated | ||
预计入组 ICMJE |
86 | ||
原始预计入组 ICMJE | 与当前相同 | ||
预计研究完成日期 | May 30, 2018 | ||
预计主要完成日期 | April 20, 2018 (主要结果测量的最终数据收集日期) | ||
合格标准 ICMJE | Inclusion criteria: MS clinically diagnosed based on McDonald's criteria of 2011 The EDSS between 1.5-4; relapsing-remitting form MS; exclusio criteria Mental disorders, alcoholism, severe vision disorders including diplopia coinciding upper limb therapy | ||
性别 |
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年龄 | 最小年龄:18 Years ,最大年龄:65 Years | ||
接受健康的志愿者 | 没有 | ||
可入组国家 ICMJE | Poland | ||
管理信息 | 数据检测委员会 | No | |
研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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IPD 共享声明 |
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责任方 | Pawlukowska Wioletta,Pomeranian Medical University Szczecin | ||
研究赞助商 ICMJE | Pomeranian Medical University Szczecin | ||
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研究员 ICMJE |
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PRS 账户 | Pomeranian Medical University Szczecin | ||
验证日期 | October 2018 | ||
ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |