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临床试验/NCT01010607
NCT01010607Unknown1 期

Use of Tendon Vibration and Mirror for the Improvement of Upper Limb Function and Pain Reduction After Stroke

Hadassah Medical Organization1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2009年11月1日最近更新:
适应症
干预措施

试验速览

阶段
1 期
入组人数
30
试验地点
1
主要终点
Upper Limb function according to Fugl-Meyer assessment

研究概览

简要总结

Upper limb paralysis following stroke is a very common problem. Only 30% of stroke patients who suffer from upper limb paresis experience a full recovery of function. There is a need for the development of more efficient rehabilitation methods for the improvement of the paralysed upper limb function.

It has been shown that the use of mirror therapy after a stroke induces the activation of motor, sensory and associative regions in the affected hemisphere and is associated with an improvement in the function of the affected limb. Mirror therapy is a treatment modality in which the affected arm is hidden from the patient's sight; the patient is instructed to watch the reflection of his healthy hand on a mirror while he performs movements with his healthy hand and tries to move simultaneously his affected hand. This induces the illusion that his affected hand moves well.

It has also been shown that applying vibration to a muscle tendon at frequencies between 50-100 Hz induces an illusion of elongation of the vibrated muscle, if visual feedback is prevented. For instance, vibrating the triceps will induce a strong illusion of elbow flexion.

In the present study the investigators will couple the use of a mirror with the application of vibration to tendons, in order to obtain a multisensorial and strong illusion of movement in the paralyzed limb.

The study hypothesis is that the administration of mirror therapy together with vibration will induce the activation of multiple motor, sensory and associative areas in the affected brain hemisphere, resulting in improvement of the affected upper limb function, compared to the administration of mirror therapy alone or sham therapy.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Stroke onset 1 month-1 year ago
  • •NIH Stroke Scale 3-15 on admission to study
  • •Affected Upper limb function 10-90% on Fugl-Meyer scale
  • •Ability to understand instructions and to move freely the unaffected upper limb

排除标准

  • •Severe cognitive impairment- severe Aphasia or severe Neglect that impair ability to understand instructions or to execute tasks

研究组 & 干预措施

Vibraton Mirror (VM)

Experimental

subjects will receive tendon vibration AND mirror therapy

干预措施: Vibration and Mirror (Device)

Mirror (M)

Active Comparator

Subjects will receive treatment only with Mirror, together with sham vibration (over bone instead of tendon)

干预措施: Mirror therapy (Device)

Sham (S)

Sham Comparator

Opaque board instead of mirror, bone vibration instead of tendon vibration

干预措施: no mirror, sham vibration (Device)

结局指标

主要结局

Upper Limb function according to Fugl-Meyer assessment

时间窗: after treatment, and 3 months after treatment

次要结局

  • Activity of Daily living performance assessed by FIM (Functional Independence Measurement) score(after treatment and 3 months after treatment)

研究者

申办方类型
Other

研究点 (1)

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