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临床试验/NCT04768140
NCT04768140已完成不适用

The Effect Of Bobath Approach On Hemiplegic Shoulder Pain, Spasticity And Upper Extremity Functionality In Stroke Patients: A Prospective, Randomized, Controlled And Single-Blind Trial

Istanbul Arel University2 个研究点 分布在 2 个国家目标入组 30 人开始时间: 2019年8月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
2
主要终点
Change from baseline Fugl-Meyer Assessment score at 30 sessions, 6 weeks

研究概览

简要总结

In this study, it is investigated that whether Bobath approach is superior to conventional physiotherapy in terms of improving hemiplegic shoulder pain, spasticity and upper extremity functionality in stroke patients.

详细描述

Objective

This study aims to determine the effect of Bobath approach on hemiplegic shoulder pain, spasticity and upper extremity functionality in stroke patients.

Patients and Methods: For this prospective, randomized, controlled and single-blind trial, 30 stroke patients aged 40-65 years with hemiplegic shoulder pain were included. Patients were divided into two groups and randomized into these groups. Only conventional physiotherapy was applied to the control group, whereas both conventional physiotherapy and Bobath exercises were also applied to the experimental group. Visual analog scale (horizontal) for shoulder pain, modified Ashworth scale for spasticity and Fugl-Meyer assessment of the upper extremity for functionality were used for both pre-test and post-test.

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)

盲法说明

SINGLE-BLIND TRIAL The patients were blinded to their group allocation.

入排标准

年龄范围
40 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients between the ages of 40 and 65
  • Patients who had a stroke for the first time and had a disease duration of at least four weeks
  • Patients who were diagnosed with ischemic or hemorrhagic stroke
  • Patients who had Brunnstrom stage 3, 4 or 5 and had hemiplegic shoulder pain were included in the study.

排除标准

  • Patients with severe cognitive impairment who could not understand simple verbal commands
  • Those who had severe dysarthria to prevent verbal communication
  • Those with unilateral neglect syndrome
  • Those with loss of sensation in the upper extremity of the hemiplegic side
  • Those with botulinum toxin-A injected to the hemiplegic upper extremity muscles
  • Those with previous shoulder-related trauma or pain history
  • Those with other accompanying neurological disease were excluded from the study.

结局指标

主要结局

Change from baseline Fugl-Meyer Assessment score at 30 sessions, 6 weeks

时间窗: First evaluation: immediately before starting the treatment; the last evaluation: at the end of the treatment of 6 weeks

Upper extremity functionality, min-max: 0-66, "0" indicates no function of upper extremity, "66" indicates the highest functionality of upper extremity as possible.

次要结局

  • Change from baseline Visual Analog Scale (horizontal) value at 30 sessions, 6 weeks(First evaluation: immediately before starting the treatment; the last evaluation: at the end of the treatment of 6 weeks)
  • Change from baseline modified Ashworth scale value at 30 sessions, 6 weeks(First evaluation: immediately before starting the treatment; the last evaluation: at the end of the treatment of 6 weeks)

研究者

发起方
Istanbul Arel University
申办方类型
Other
责任方
Principal Investigator
主要研究者

NAZLI GÜNGÖR

Research Assistant, Department of Physiotherapy and Rehabilitation, Health Sciences School

Istanbul Arel University

研究点 (2)

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