Stroke, AcuteNCT03429855
Bobath Approach for Trunk Control in Acute Stroke Patients
A study testing trunk training and physiotherapy in people with Stroke, Acute, run by Hacettepe University at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 42 to 78 years
- Conditions the study is for
- Stroke, Acute
- What is being tested?
- trunk training and physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Mar 2018to 1 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 42 to 78 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients scoring ≥14 on Glasgow Coma Scale and Mini Mental Test>24
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke, Acute
- Being tested
- trunk training, physiotherapy
- Keywords
- Physiotherapy, Trunk control, Bobath concept, Stroke rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trunk trainingOther
Bobath based trunk training
physiotherapyOther
conventional physiotherapy
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | Bobath based trunk exercises Receives: Other: trunk training |
| control group | Other | conventional physiotherapy approaches Receives: Other: physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from Baseline sitting time at 20th days in hospital
Secondary outcomes (3)
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.
Measured: Baseline, on 7th, 10th and 20th days during the treatment
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).
Measured: Baseline, on 7th, 10th and 20th days during the treatment
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.
Measured: Baseline, on 7th, 10th and 20th days during the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2018
- Study start10 Mar 2018
- Primary completion8 Oct 2019
- Study completion1 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ayla fil balkan, Hacettepe University
- Investigators
- Ayla Fil Balkan, Asst. Prof, Principal investigator, Hacettepe UniversityAli Naim Ceren, MSc, Study chair, Hacettepe UniversityCeren Saban, MSc, Study chair, Eskişehir Osmangazi University Health Application and Research HospitalYeliz Salcı, Asst. Prof, Study chair, Hacettepe UniversityHilal Keklicek, Asst. Prof, Study chair, Trakya UniversityKadriye Armutlu, Prof Dr, Study chair, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03429855
- Sponsor's protocol ID
- KA-16073
- Status last verified
- Jul 2020
- First submitted
- 22 Jan 2018
- Last updated
- 7 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 15137564Verheyden 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.
PubMed 17613559Collin 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.
PubMed 2391521Carr 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.
PubMed 3969398Bank 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.
PubMed 26086177Kilinc 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.
PubMed 26260878Benito 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.
PubMed 25475602Cabanas-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.
PubMed 24018373
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Bobath Based Trunk Training on in Acute Stroke Patients: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03429855
- Acronym / sponsor ID
- KA-16073
- Conditions
- Stroke, Acute
- Keywords
- Physiotherapy, Trunk control, Bobath concept, Stroke rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 10 Mar 2018 (actual)
- Primary completion
- 8 Oct 2019 (actual)
- Study completion
- 1 Nov 2019 (actual)
- First posted
- 12 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- randomized controlled
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Other: trunk trainingBobath based trunk exercises |
| control group | Other | Other: physiotherapyconventional physiotherapy approaches |
Who may qualify
- Ages
- 42 to 78 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients scoring ≥14 on Glasgow Coma Scale and Mini Mental Test>24
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| trunk trainingBobath based trunk training | Other | study group |
| physiotherapyconventional physiotherapy | Other | control group |
Primary outcome
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.
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.
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.
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.
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.
3 secondary outcomes
Glasgow Coma Scale
Time frame: 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 Functional Independence Measure (FIM)
Time frame: Baseline, on 7th, 10th and 20th days during the treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
- Background: PubMed 15137564Verheyden 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.
- Background: PubMed 17613559Verheyden 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.
- Background: PubMed 2391521Collin 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.
- Background: PubMed 3969398Carr 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.
- Background: PubMed 26086177Bank 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.
- Background: PubMed 26260878Kilinc 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.
- Background: PubMed 25475602Benito 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.
- Background: PubMed 24018373Cabanas-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayla Fil Balkan, Asst. Prof principal investigator
Hacettepe University
Ali Naim Ceren, MSc study chair
Hacettepe University
Ceren Saban, MSc study chair
Eskişehir Osmangazi University Health Application and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing trunk training and physiotherapy in people with Stroke, Acute, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trunk Impairment Scale (by Verheyden) (time frame: Change from Baseline the scale score at 20th days in hospital). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03429855, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2020.