Bobath Approach for Trunk Control in Acute Stroke Patients

July 2, 2020 updated by: ayla fil balkan, Hacettepe University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

81

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06100
        • Hacettepe University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

42 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: study group
Bobath based trunk exercises
Other: trunk training
Bobath based trunk training
Other: control group
conventional physiotherapy approaches
Other: physiotherapy
conventional physiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Trunk Impairment Scale (by Verheyden)
Time Frame: 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.
Change from Baseline the scale score at 20th days in hospital
Trunk Control Test
Time Frame: 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.
Change from Baseline the scale score at 20th days in hospital
Motor Assessment Scale
Time Frame: 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.
Change from Baseline the scale score at 20th days in hospital
Berg Balance Scale
Time Frame: 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.
Change from Baseline the scale score at 20th days in hospital
independently sitting time
Time Frame: Change from Baseline sitting time at 20th days in hospital
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
Time Frame: Baseline, on 7th, 10th and 20th days during the treatment
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
Time Frame: Baseline, on 7th, 10th and 20th days during the treatment
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)
Time Frame: Baseline, on 7th, 10th and 20th days during the treatment
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hacettepe University

Investigators

  • Study Chair: Ali Naim Ceren, Msc, Hacettepe University
  • Principal Investigator: Ayla Fil Balkan, Asst. Prof, Hacettepe University
  • Study Chair: Ceren Saban, MSc, Eskişehir Osmangazi University Health Application and Research Hospital
  • Study Chair: Yeliz Salcı, Asst. Prof, Hacettepe University
  • Study Chair: Hilal Keklicek, Asst. Prof, Trakya University
  • Study Chair: Kadriye Armutlu, Prof Dr, Hacettepe University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2018

Primary Completion (Actual)

October 8, 2019

Study Completion (Actual)

November 1, 2019

Study Registration Dates

First Submitted

January 22, 2018

First Submitted That Met QC Criteria

February 5, 2018

First Posted (Actual)

February 12, 2018

Study Record Updates

Last Update Posted (Actual)

July 7, 2020

Last Update Submitted That Met QC Criteria

July 2, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KA-16073

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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