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临床试验/NCT00360789
NCT00360789已完成1 期

The Effects of Standardized Physical Therapy and Functional Strength Training on Upper Limb Function and Neuromuscular Weakness After Stroke: a Pilot Study

St George's, University of London1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2005年6月1日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
30
试验地点
1
主要终点
Action Research Arm Test (ARAT)

研究概览

简要总结

The purpose of this study is to test the hypothesis that adding functional strength training to UK conventional therapy improves muscle function and walking than either UK conventional therapy alone or increased intensity of UK conventional therapy.

详细描述

Neuromuscular weakness occurs frequently after stroke and the processes underlying recovery are still poorly understood. Accepted practice in UK physiotherapy is to avoid training of muscle strength after stroke but there is preliminary evidence that it might be effective.

An observer-blind randomised pilot clinical trial (Phase II). Subjects will be within 3 months of first stroke with some voluntary movement in the paretic upper limb.

A Research Physiotherapist, blinded to measurement, will recruit subjects, allocate subjects to one of three intervention groups using sequentially numbered sealed envelopes containing previously allocated intervention cards and provide interventions. Ten participants will be recruited to each group therefore the trial will recuit 30 participants. The Research Assessor, blinded to intervention allocation will undertake all measurements.

Conventional therapy (control) will be provided as normal for the clinical setting, the additional conventional therapy (experimental 1)or functional strength training (experimental 2) will be provided for one hour, five times a week for six weeks. Subjects in the two experimental groups will also receive the conventional therapy standard in their clinical setting.

Blinded measurement will be made before randomisation, at the end of intervention and 12-weeks thereafter. Primary outcomes are the Action Research Arm Test (ARAT)and the Nine Hole Peg Test (9HPT). The secondary outcomes are peak torque around the elbow joint in elbow flexion and extension, grip force, pinch force, smoothness of movement during turning a cranked wheel and reciprocal inniveration of biceps and triceps during turning of a cranked wheel.

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

入排标准

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

入选标准

  • Be between one week and three months after stroke when recruited to the study
  • Have some voluntary muscle activity in the paretic upper limb

排除标准

  • Obvious unilateral visuospatial neglect
  • Upper limb movement deficits attributable to non-stroke pathology

结局指标

主要结局

Action Research Arm Test (ARAT)

Nine Hole Peg Test (9HPT)

次要结局

  • grip force
  • pinch force
  • peak torque around the elbow joint in elbow flexion and extension
  • smoothness of movement during turning a cranked wheel
  • reciprocal inneveration of biceps and triceps during turning of a cranked wheel.

研究者

申办方类型
Other

研究点 (1)

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