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临床试验/NCT03429855
NCT03429855已完成不适用

Effectiveness of Bobath Based Trunk Training on in Acute Stroke Patients: a Randomized Controlled Trial

Hacettepe University2 个研究点 分布在 1 个国家目标入组 81 人开始时间: 2018年3月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
81
试验地点
2
主要终点
Berg Balance Scale

研究概览

简要总结

In stroke patients, the impairment of the trunk affects many functions negatively. For this reason training of the trunk is necessary in the early period. Taking into account of literature, various approaches have been used to improve sitting balance and trunk control such as conventional physiotherapy for stroke patients . Bobath concept is another method used for stroke rehabilitation. When the studies about stroke rehabilitation are investigated, it is seen that most of the studies included only chronic patients and Bobath concept did not adequately take place in literature about trunk training. The aim of this study is to determinate effectiveness of the Bobath based trunk training on trunk control in acute stroke patients.

详细描述

In stroke patients, the impairment of the trunk affects many functions negatively. For this reason training of the trunk is necessary in the early period. Taking into account of literature, various approaches have been used to improve sitting balance and trunk control such as conventional physiotherapy for stroke patients . Bobath concept is another method used for stroke rehabilitation. Trunk control is an important issue in the Bobath approach since the acute period. It seems that the Bobath method, which includes both approaches to increase postural control and sitting, as well as applications to increase the sensation, seems to be an appropriate method to improve body control in stroke patients. When the studies about stroke rehabilitation are investigated, it is seen that most of the studies included only chronic patients and Bobath concept did not adequately take place in literature about trunk training in acute stroke. The aim of this study is to determinate effectiveness of the Bobath based trunk training on trunk control in acute stroke patients.

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
42 Years 至 78 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients scoring ≥14 on Glasgow Coma Scale and Mini Mental Test>24

排除标准

  • patients scoring <14 on Glasgow Coma Scale
  • patients with recurrent strokes
  • patients with orthopedic or neurological disorders (other than strokes) that might affect their motor performance

结局指标

主要结局

Berg Balance Scale

时间窗: Change from Baseline the scale score at 20th days in hospital

The Berg Balance Scale (BBS) was developed to measure balance among older people with impairment in balance function by assessing the performance of functional tasks. It is a valid instrument used for evaluation of the effectiveness of interventions and for quantitative descriptions of function in clinical practice and research. The BBS has been evaluated in several reliability studies.

independently sitting time

时间窗: Change from Baseline sitting time at 20th days in hospital

Sitting with back unsupported without using hands but feet supported on floor.

Trunk Control Test

时间窗: Change from Baseline the scale score at 20th days in hospital

The test consists of four items which are assessed on a 3-point ordinal scale.The total score for the Trunk Control Test ranges from minimum 0 to maximum 100 points, a higher score indicating a better performance.

Motor Assessment Scale

时间窗: Change from Baseline the scale score at 20th days in hospital

It contains three items assessing trunk performance. Each item is scored on a 7-point ordinal scale, a higher score indicating a better performance.

Trunk Impairment Scale (by Verheyden)

时间窗: Change from Baseline the scale score at 20th days in hospital

It consists of 3 subscales of static and dynamic sitting balance and trunk coordination, scored up to 7, 10, and 6 points, respectively.The total scores range between 0 and 23 points, where a higher score indicates better truncal function.

次要结局

  • Modified Rankin Scale(Baseline, on 7th, 10th and 20th days during the treatment)
  • Glasgow Coma Scale(Baseline, on 7th, 10th and 20th days during the treatment)
  • The Functional Independence Measure (FIM)(Baseline, on 7th, 10th and 20th days during the treatment)

研究者

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

ayla fil balkan

assoc prof

Hacettepe University

研究点 (2)

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