Bobath Approach for Trunk Control in Acute Stroke Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Stroke, Acute

Intervention / Treatment
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* Other: trunk training
* Other: physiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients scoring ≥14 on Glasgow Coma Scale and Mini Mental Test>24 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 42 Years
Maximum Age: 78 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized controlled
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: study group<br>Bobath based trunk exercises | Other: trunk training<br>* Bobath based trunk training<br>|
| Other: control group<br>conventional physiotherapy approaches | Other: physiotherapy<br>* conventional physiotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trunk Impairment Scale (by Verheyden) | 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. | Change from Baseline the scale score at 20th days in hospital | 
| Trunk Control Test | 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. | Change from Baseline the scale score at 20th days in hospital | 
| Motor Assessment Scale | It contains three items assessing trunk performance. Each item is scored on a 7-point ordinal scale, a higher score indicating a better performance. | Change from Baseline the scale score at 20th days in hospital | 
| Berg Balance Scale | 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. | Change from Baseline the scale score at 20th days in hospital | 
| independently sitting time | Sitting with back unsupported without using hands but feet supported on floor. | Change from Baseline sitting time at 20th days in hospital | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glasgow Coma Scale | It assessed the initial and subsequent level of consciousness in a person after a brain injury. Mild head injuries are generally defined as those associated with a Glasgow Coma scale score of 13-15. | Baseline, on 7th, 10th and 20th days during the treatment | 
| Modified Rankin Scale | The Modified Rankin Scale (MRS) is the most commonly used to evaluate the degree of disability or dependence in the daily activities of people who have suffered a stroke. It describes global disability with a focus on mobility. The MRS is an ordered scale coded from 0 (no symptoms at all) through 5 (severe disability) 6 (death). | Baseline, on 7th, 10th and 20th days during the treatment | 
| The Functional Independence Measure (FIM) | The Functional Independence Measure (FIM) evaluates self-care, sphincter control, mobility, locomotion, communication, and social cognition. The FIM item scores range from 1 (total assistance required) to 7 (complete independence). A higher score indicates a greater degree of independence with regard to daily living activities. This subscale has good psychometric properties for stroke patients. | Baseline, on 7th, 10th and 20th days during the treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Physiotherapy, Trunk control, Bobath concept, Stroke rehabilitation