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临床试验/NCT01200030
NCT01200030已完成不适用

A Home-Based Program of Transcutaneous Electrical Nerve Stimulation and Task-Related Trunk Training Improves Trunk Control in Patients With Stroke: A Randomized Controlled Clinical Trial

The Hong Kong Polytechnic University1 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2010年8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
37
试验地点
1
主要终点
Trunk Impairment Scale

研究概览

简要总结

The investigators hypothesize that application of electrical stimulation would augment the effects of exercises in patients with stroke. Combined electrical stimulation with exercises for 6 weeks would lead to earlier and greater improvement in motor functions when compared with placebo-stimulation with exercises.

详细描述

Previous studies have shown that repeated sensory inputs from transcutaneous electrical stimulation (TES) could enhance brain plasticity and conical motor output. Home-based rehabilitation is shown to be effective in motor recovery and improvement of functional ability in stroke rehabilitation.

The aim of this study was to develop a home-based rehabilitation program to investigate whether combined electrically induced sensory inputs through TES with task-related trunk training (TRTT) in a home-based program would induce earlier and/or greater improvement in, seated reaching distance and trunk control when compared with placebo TES and TRTT, or control with no active treatment in subjects with chronic stroke.

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 (Participant)

入排标准

年龄范围
45 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis with first stroke for more than 6 months
  • Discharge from all rehabilitation services
  • Ability to understand and follow commands
  • A carer able for helping the home program
  • No contraindication to assessment protocol and training

排除标准

  • Cognitive disorder with Abbreviated Mental Test less than 7
  • Unilateral neglect with Star cancellation Test less than 47
  • Sensory deficit
  • Unable to give informed consent
  • Unable to speak either Cantonese or English or Mandarin
  • Commodity that preclude them from undergoing training and assessment
  • Neurological disease other than stroke

结局指标

主要结局

Trunk Impairment Scale

时间窗: baseline, 6 weeks

The Trunk impairment scale is a 2 to 4-point ordinal scale. The scale assesses static and dynamic sitting balance and trunk coordination. The maximum scores on the static sitting balance, dynamic sitting balance, and coordination subscales are 7, 10, and 6 points, respectively. The total score of Trunk impairment scale ranges between 0 and 23 points, with a higher score representing better trunk control. The static sitting balance subscale evaluated the trunk stability with both feet on the floor and with the legs crossed. The dynamic sitting balance subscale evaluated the ability to perform trunk side flexion. The coordination components evaluated the ability to selectively rotate the upper and lower parts of the trunk.

次要结局

  • Forward Sitting Functional Reach Test(baseline, 6 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shamay Ng

Associate Professor

The Hong Kong Polytechnic University

研究点 (1)

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