Bobath Approach for Trunk Control in Acute Stroke Patients

NCT03429855 | Completed

• 1 other identifier: KA-16073
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke, Acute

Keywords

Physiotherapy; Trunk control; Bobath concept; Stroke rehabilitation

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• Glasgow Coma Scale

  Baseline, on 7th, 10th and 20th days during the treatment

• Modified Rankin 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

Study Arms (2)

study group

EXPERIMENTAL

Bobath based trunk exercises

Other: trunk training

control group

OTHER

conventional physiotherapy approaches

Other: physiotherapy

Interventions

trunk training OTHER

Bobath based trunk training

study group

physiotherapy OTHER

conventional physiotherapy

control group

Eligibility Criteria

• Age: 42 Years - 78 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, 06100, Turkey (Türkiye)

Location

Related Publications (8)

• 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.

  PMID: 15137564 BACKGROUND

• 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.

  PMID: 17613559 BACKGROUND

• 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.

  PMID: 2391521 BACKGROUND

• 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.

  PMID: 3969398 BACKGROUND

• 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.

  PMID: 26086177 BACKGROUND

• 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.

  PMID: 26260878 BACKGROUND

• 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.

  PMID: 25475602 BACKGROUND

• 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.

  PMID: 24018373 BACKGROUND

MeSH Terms

Conditions

Stroke

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Ayla Fil Balkan, Asst. Prof

  Hacettepe University

  PRINCIPAL INVESTIGATOR

• Ali Naim Ceren, MSc

  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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assoc prof

Model Details: randomized controlled

Study Record Dates

• First Submitted: January 22, 2018
• First Posted: February 12, 2018
• Study Start: March 10, 2018
• Primary Completion: October 8, 2019
• Study Completion: November 1, 2019
• Last Updated: July 7, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)