Bobath Approach for Trunk Control in Acute Stroke Patients

Stroke, Acute Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03429855
• Other study ID #: KA-16073
• Status: Completed
• Phase: N/A
• Start date: March 10, 2018
• Est. completion date: November 1, 2019

Study information

• Verified date: July 2020
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: November 1, 2019
• Est. primary completion date: October 8, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 42 Years to 78 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke
• Stroke, Acute

Intervention

Other:
• trunk training
Bobath based trunk training
• physiotherapy
conventional physiotherapy

Locations

Country	Name	City	State
Turkey	Hacettepe University	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

References & Publications (8)

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. Review. — View Citation

Benito García M, Atín Arratibel MÁ, 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. — View Citation

Cabanas-Valdés 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. Review. — View 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. — View Citation

Collin C, Wade D. Assessing motor impairment after stroke: a pilot reliability study. J Neurol Neurosurg Psychiatry. 1990 Jul;53(7):576-9. — View Citation

Kilinç 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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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