Clinical trial NCT03429855: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stroke, Acute
Keywords: Physiotherapy
Trunk control
Bobath concept
Stroke rehabilitation
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2018-02-12
Enrollment: 81
Sex: ALL
Minimum age (years): 42
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Trunk Impairment Scale (by Verheyden)
timeFrame: Change from Baseline the scale score at 20th days in hospital
measure: Trunk Control Test
timeFrame: Change from Baseline the scale score at 20th days in hospital
measure: Motor Assessment Scale
timeFrame: Change from Baseline the scale score at 20th days in hospital
measure: Berg Balance Scale
timeFrame: Change from Baseline the scale score at 20th days in hospital
measure: independently sitting time
timeFrame: Change from Baseline sitting time at 20th days in hospital
Secondary outcomes:
measure: Glasgow Coma Scale
timeFrame: Baseline, on 7th, 10th and 20th days during the treatment
measure: Modified Rankin Scale
timeFrame: Baseline, on 7th, 10th and 20th days during the treatment
measure: The Functional Independence Measure (FIM)
timeFrame: Baseline, on 7th, 10th and 20th days during the treatment
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
affiliation: Hacettepe University
name: Ayla Fil Balkan, Asst. Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: Ali Naim Ceren, MSc
role: STUDY_CHAIR
affiliation: Eskişehir Osmangazi University Health Application and Research Hospital
name: Ceren Saban, MSc
role: STUDY_CHAIR
affiliation: Hacettepe University
name: Yeliz Salcı, Asst. Prof
role: STUDY_CHAIR
affiliation: Trakya University
name: Hilal Keklicek, Asst. Prof
role: STUDY_CHAIR
affiliation: Hacettepe University
name: Kadriye Armutlu, Prof Dr
role: STUDY_CHAIR
References:
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.
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.
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.
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.
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.
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.
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.
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.