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临床试验/NCT01507636
NCT01507636已完成不适用

Apraxia-specific Occupational Therapy in Patients With Multiple Sclerosis

Insel Gruppe AG, University Hospital Bern2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2012年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
Change in apraxia score as measured by TULIA

研究概览

简要总结

Limb apraxia is defined as the inability to correctly perform skilled and/or learned limb movements, which cannot be explained by elementary motor and sensory deficits or cognitive problems. Multiple Sclerosis (MS) is a chronic inflammatory disease of the central nervous system and the leading cause of disability in young adults. Apraxia and impaired manual dexterity are common problems in patients with MS leading to impaired activities of daily living. However, a specific training program to improve apraxia as well as manual dexterity in MS is lacking.

In this study, the investigators want to evaluate the impact of a targeted occupational therapy program on apraxia and manual dexterity in patients with MS that have dexterity problems.

Patients routinely seen in the investigators MS consulting hour, fulfilling all inclusion and exclusion criteria and willing to participate in the study will be evaluated for Apraxia and manual dexterity. In case of Apraxia and/or impaired manual dexterity, patients will be randomized 1:1 using sealed envelopes to receive occupational home therapy (experimental group) or general physical exercises (control group) for 4 weeks.

At study entry and study end after 4 weeks, apraxia and manual dexterity will be tested in all patients.

详细描述

Background

Limb apraxia is defined as the inability to correctly perform skilled and/or learned limb movements, which cannot be explained by elementary motor and sensory deficits or cognitive problems. It impairs real object/tool use as well as pantomime and imitation of gestures affecting both sides of the body and can be a major source of disability independent of other neurological deficits. It significantly affects activities of daily living (ADL) and is associated with poorer outcome for independent living or return to work.

Apraxia is largely based on left parieto-frontal damage due to focal injury or more widespread neurodegeneration of cortical areas and/or their connections. However, apraxia has been described in damage of the right hemisphere, although less frequent and severe.

Apraxia is increasingly recognized as a clinical problem in restorative neurology and various approaches were described how to treat the disorder.

Multiple Sclerosis (MS) is a chronic inflammatory disease of the central nervous system and the leading cause of disability in young adults. It is characterized by focal demyelination as well as axonal damage. MS has been classically thought of as a typical white matter disorder. However, early pathology studies and recent magnetic resonance tomography (MRI) studies show demyelination in the cortex and deep gray matter nuclei. Grey matter damage starts early in the disease and substantially affects cognitive functioning.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with all forms of MS
  • Age 18-60 years
  • Exclusion Criteria
  • Any disease other than multiple sclerosis that could possibly explain the patient's signs and symptoms
  • A relapse which started within 60 days prior to the examination
  • Uncontrolled, clinically significant heart diseases, such as arrhythmias, angina, Coronary heart disease or uncompensated congestive heart failure, medication with glycosides.
  • A history of drug abuse in the 6 months prior to screening

排除标准

  • 未提供

结局指标

主要结局

Change in apraxia score as measured by TULIA

时间窗: From day of randomisation to end of study, expected to be after 4 weeks

次要结局

  • Change in activities of daily living(From day of randomisation to end of study, expected to be after 4 weeks)
  • Change in quality of life(From day of randomisation to end of study, expected to be after 4 weeks)
  • Change in manual dexterity(From day of randomisation to end of study, expected to be after 4 weeks)
  • Change in fatigue(From day of randomisation to end of study, expected to be after 4 weeks)

研究者

申办方类型
Other

研究点 (2)

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