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Bobath Approach for Trunk Control in Acute Stroke Patients

Primary Purpose

Stroke, Acute

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
trunk training
physiotherapy
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke, Acute focused on measuring Physiotherapy, Trunk control, Bobath concept, Stroke rehabilitation

Eligibility Criteria

42 Years - 78 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hacettepe University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

study group

control group

Arm Description

Bobath based trunk exercises

conventional physiotherapy approaches

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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).
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.

Full Information

First Posted
January 22, 2018
Last Updated
July 2, 2020
Sponsor
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT03429855
Brief Title
Bobath Approach for Trunk Control in Acute Stroke Patients
Official Title
Effectiveness of Bobath Based Trunk Training on in Acute Stroke Patients: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
March 10, 2018 (Actual)
Primary Completion Date
October 8, 2019 (Actual)
Study Completion Date
November 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Acute
Keywords
Physiotherapy, Trunk control, Bobath concept, Stroke rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized controlled
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
study group
Arm Type
Experimental
Arm Description
Bobath based trunk exercises
Arm Title
control group
Arm Type
Other
Arm Description
conventional physiotherapy approaches
Intervention Type
Other
Intervention Name(s)
trunk training
Intervention Description
Bobath based trunk training
Intervention Type
Other
Intervention Name(s)
physiotherapy
Intervention Description
conventional physiotherapy
Primary Outcome Measure Information:
Title
Trunk Impairment Scale (by Verheyden)
Description
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.
Time Frame
Change from Baseline the scale score at 20th days in hospital
Title
Trunk Control Test
Description
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.
Time Frame
Change from Baseline the scale score at 20th days in hospital
Title
Motor Assessment Scale
Description
It contains three items assessing trunk performance. Each item is scored on a 7-point ordinal scale, a higher score indicating a better performance.
Time Frame
Change from Baseline the scale score at 20th days in hospital
Title
Berg Balance Scale
Description
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.
Time Frame
Change from Baseline the scale score at 20th days in hospital
Title
independently sitting time
Description
Sitting with back unsupported without using hands but feet supported on floor.
Time Frame
Change from Baseline sitting time at 20th days in hospital
Secondary Outcome Measure Information:
Title
Glasgow Coma Scale
Description
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.
Time Frame
Baseline, on 7th, 10th and 20th days during the treatment
Title
Modified Rankin Scale
Description
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).
Time Frame
Baseline, on 7th, 10th and 20th days during the treatment
Title
The Functional Independence Measure (FIM)
Description
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.
Time Frame
Baseline, on 7th, 10th and 20th days during the treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
42 Years
Maximum Age & Unit of Time
78 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayla Fil Balkan, Asst. Prof
Organizational Affiliation
Hacettepe University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ali Naim Ceren, MSc
Organizational Affiliation
Hacettepe University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ceren Saban, MSc
Organizational Affiliation
Eskişehir Osmangazi University Health Application and Research Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Yeliz Salcı, Asst. Prof
Organizational Affiliation
Hacettepe University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Hilal Keklicek, Asst. Prof
Organizational Affiliation
Trakya University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Kadriye Armutlu, Prof Dr
Organizational Affiliation
Hacettepe University
Official's Role
Study Chair
Facility Information:
Facility Name
Hacettepe University
City
Ankara
ZIP/Postal Code
06100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
15137564
Citation
Verheyden G, Nieuwboer A, Mertin J, Preger R, Kiekens C, De Weerdt W. The Trunk Impairment Scale: a new tool to measure motor impairment of the trunk after stroke. Clin Rehabil. 2004 May;18(3):326-34. doi: 10.1191/0269215504cr733oa.
Results Reference
background
PubMed Identifier
17613559
Citation
Verheyden G, Nieuwboer A, Van de Winckel A, De Weerdt W. Clinical tools to measure trunk performance after stroke: a systematic review of the literature. Clin Rehabil. 2007 May;21(5):387-94. doi: 10.1177/0269215507074055.
Results Reference
background
PubMed Identifier
2391521
Citation
Collin C, Wade D. Assessing motor impairment after stroke: a pilot reliability study. J Neurol Neurosurg Psychiatry. 1990 Jul;53(7):576-9. doi: 10.1136/jnnp.53.7.576.
Results Reference
background
PubMed Identifier
3969398
Citation
Carr JH, Shepherd RB, Nordholm L, Lynne D. Investigation of a new motor assessment scale for stroke patients. Phys Ther. 1985 Feb;65(2):175-80. doi: 10.1093/ptj/65.2.175.
Results Reference
background
PubMed Identifier
26086177
Citation
Bank J, Charles K, Morgan P. What is the effect of additional physiotherapy on sitting balance following stroke compared to standard physiotherapy treatment: a systematic review. Top Stroke Rehabil. 2016 Feb;23(1):15-25. doi: 10.1179/1945511915Y.0000000005. Epub 2015 Jun 18.
Results Reference
background
PubMed Identifier
26260878
Citation
Kilinc M, Avcu F, Onursal O, Ayvat E, Savcun Demirci C, Aksu Yildirim S. The effects of Bobath-based trunk exercises on trunk control, functional capacity, balance, and gait: a pilot randomized controlled trial. Top Stroke Rehabil. 2016 Feb;23(1):50-8. doi: 10.1179/1945511915Y.0000000011. Epub 2015 Aug 10.
Results Reference
background
PubMed Identifier
25475602
Citation
Benito Garcia M, Atin Arratibel MA, Terradillos Azpiroz ME. The Bobath Concept in Walking Activity in Chronic Stroke Measured Through the International Classification of Functioning, Disability and Health. Physiother Res Int. 2015 Dec;20(4):242-50. doi: 10.1002/pri.1614. Epub 2014 Dec 4.
Results Reference
background
PubMed Identifier
24018373
Citation
Cabanas-Valdes R, Cuchi GU, Bagur-Calafat C. Trunk training exercises approaches for improving trunk performance and functional sitting balance in patients with stroke: a systematic review. NeuroRehabilitation. 2013;33(4):575-92. doi: 10.3233/NRE-130996.
Results Reference
background

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Bobath Approach for Trunk Control in Acute Stroke Patients

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