StrokeNCT04816929
The Effects of Bobath Method and Task-Oriented Approach in Stroke Patients
A study testing Bobath Method and Task-Oriented Approach in people with Stroke, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Trunk impairment and asymmetry that occur after stroke negatively affect many functional activities in the daily lives of patients. There are different neurophysiological approaches such as Bobath method and task-oriented approach used in post-stroke rehabilitation programs in the literature. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Bobath Method and Task-Oriented Approach
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Jan 2021to 20 Apr 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unilateral stroke for more than 3 months
- Being over the age of 18
- Having trunk impairment (not having full points in the Trunk Impairment Scale)
- Being able to walk without support or with walking aid.
Who cannot join
- Having recurrent stroke
- Having an orthopedic or neurological disorders other than stroke that may affect motor performance
- Having a cognitive problem (Not having Mini Mental State Examination score ≥ 24)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University, Faculty of Physical Therapy and Rehabilitation
Ankara, Altındağ, 06100
About this study
Official title: Investigation of Effects of Bobath Method and Task-Oriented Approach on Architectural Features and Activation of Trunk Muscles and Functional Performance in Stroke Patients
Trunk impairment and asymmetry that occur after stroke negatively affect many functional activities in the daily lives of patients. There are different neurophysiological approaches such as Bobath method and task-oriented approach used in post-stroke rehabilitation programs in the literature. However, there are not many studies that comprehensively evaluate and compare the effects of these neurophysiological approaches on trunk muscles, balance and gait in stroke patients. The aim of this study is to examine and compare the effects of Bobath method and task-oriented approach on architectural features and activation of trunk muscles and functional performance in stroke patients. In addition, this study will demonstrate with muscle thickness and activation the asymmetry that may occur between the hemiparetic and non-paretic trunk muscles of stroke patients, and will allow examining the effects of these features on functional performance. This study was planned to include two treatment groups. The Bobath group will receive Bobath based trunk, balance and walking exercises, while the task-oriented group will receive exercises for oriented task. Trunk impairment, motor functions, thickness and activation of trunk muscles, spatio-temporal parameters of gait, balance and goal attainment will be assessed before and after 8 weeks treatment program. As a result; effectiveness of Bobath method and task-oriented approach will be compared and relationship between muscle thickness, activation and functional performance will be examined.
- Conditions
- Stroke
- Being tested
- Bobath Method, Task-Oriented Approach
- Keywords
- Stroke, Cerebrovascular Disorders, Trunk, Muscle Thickness, Ultrasonography, Muscle Activation, Electromyography, Gait, Balance
- Medical subject headings
- Stroke, Cerebrovascular Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bobath MethodOther
Neurodevelopmental Treatment
Task-Oriented ApproachOther
Task-Oriented Treatment
| Study group | Role | What they receive |
|---|---|---|
| Bobath Method Group | Experimental | The Bobath based exercises for 60 minutes will be formed according to the needs of the individual and will involve trunk exercises such as placing, stretching, functional reach, rotations, functional strengthening and, balance and walking exercises etc. It will be performed 3 days a week for 8 weeks. Receives: Other: Bobath Method |
| Task-Oriented Approach Group | Active comparator | The task-oriented approach for 60 minutes will be formed according to the needs of the individual and involve exercises targeting functional tasks determined. It will be performed 3 days a week for 8 weeks. Receives: Other: Task-Oriented Approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Muscle Thickness with Ultrasonography
The evaluation of muscle thickness of bilateral rectus abdominis, external oblique, latissimus dorsi and erector spinae with ultrasonography will be performed by a physician using a 5-10 MHz linear probe (Diasus Dynamic Imaging Ltd, Livingston, Scotland,UK) in resting position. Muscle Thickness would be expressed as centimeters.
Measured: change from baseline in muscle thickness of trunk muscles at 8 weeks
Evaluation of Muscle Activation with Superficial Electromyography
The evaluation of muscle activation of bilateral rectus abdominis, external oblique, latissimus dorsi and erector spinae will be performed using Delsys Trigno Superficial Electromyography System during maximum voluntary isometric contraction, gait and balance performance.
Measured: change from baseline in muscle activation of trunk muscles at 8 weeks
Evaluation of Spatio-Temporal Parameters of Gait with GAITRite Analysis System
The evaluation of spatio-temporal parameters of gait such as velocity, cadence, step time, step length, gait cycle in double and single support, stance phase, swing phase, base of support, gait symmetry will be performed using the GAITRite electronic walkway.
Measured: change from baseline in spatio-temporal parameters of gait at 8 weeks
Evaluation of Balance
The evaluation of limits of stability, anteroposterior and mediolateral sway range will be performed using the Bertec Balance Check ScreenerTM force platform system.
Measured: change from baseline in balance at 8 weeks
Secondary outcomes (3)
Trunk Impairment Scale
Trunk Impairment Scale (TIS) is a valid and reliable scale measuring trunk performance in stroke patients. TIS consists of static sitting balance, dynamic sitting balance and coordination subtitles that provide bilateral evaluation of the trunk. The total score ranges from 0-23, and high scores indicate better trunk performance.
Measured: change from baseline in trunk performance at 8 weeks
Stroke Rehabilitation Assessment of Movement
Stroke Rehabilitation Assessment of Movement (STREAM) evaluates motor function and quality of movement in stroke patients. STREAM consists of 30 items in which upper extremity, lower extremity, and basic mobility activities are represented by 10 items. The total score ranges from 0-70, and higher scores indicate better motor function.
Measured: change from baseline in motor function at 8 weeks
Goal Attainment Scaling
Goal Attainment Scaling (GAS) is a standardized outcome measure for calculating the extent to which a patient's goals are achieved. GAS involves goal selection and goal scaling. Each goal is rated on a 5-point scale between -2 and 2.
Measured: change in satisfaction regarding how to reach the goals related exercise therapy at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2021
- Study start18 Jan 2021
- Primary completion20 Apr 2022
- Study completion20 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gülşah Sütçü, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04816929
- Sponsor's protocol ID
- KA-20063
- Status last verified
- Apr 2023
- First submitted
- 21 Mar 2021
- Last updated
- 19 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Effects of Bobath Method and Task-Oriented Approach on Architectural Features and Activation of Trunk Muscles and Functional Performance in Stroke Patients
- ClinicalTrials.gov ID
- NCT04816929
- Acronym / sponsor ID
- KA-20063
- Conditions
- Stroke
- Keywords
- Stroke, Cerebrovascular Disorders, Trunk, Muscle Thickness, Ultrasonography, Muscle Activation, Electromyography, Gait
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 18 Jan 2021 (actual)
- Primary completion
- 20 Apr 2022 (actual)
- Study completion
- 20 Apr 2022 (actual)
- First posted
- 25 Mar 2021 (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.
Trunk impairment and asymmetry that occur after stroke negatively affect many functional activities in the daily lives of patients. There are different neurophysiological approaches such as Bobath method and task-oriented approach used in post-stroke rehabilitation programs in the literature. However, there are not many studies that comprehensively evaluate and compare the effects of these neurophysiological approaches on trunk muscles, balance and gait in stroke patients. The aim of this study is to examine and compare the effects of Bobath method and task-oriented approach on architectural features and activation of trunk muscles and functional performance in stroke patients. In addition, this study will demonstrate with muscle thickness and activation the asymmetry that may occur between the hemiparetic and non-paretic trunk muscles of stroke patients, and will allow examining the effects of these features on functional performance. This study was planned to include two treatment groups. The Bobath group will receive Bobath based trunk, balance and walking exercises, while the task-oriented group will receive exercises for oriented task. Trunk impairment, motor functions, thickness and activation of trunk muscles, spatio-temporal parameters of gait, balance and goal attainment will be assessed before and after 8 weeks treatment program. As a result; effectiveness of Bobath method and task-oriented approach will be compared and relationship between muscle thickness, activation and functional performance will be examined.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bobath Method Group | Experimental | Other: Bobath MethodThe Bobath based exercises for 60 minutes will be formed according to the needs of the individual and will involve trunk exercises such as placing, stretching, functional reach, rotations, functional strengthening and, balance and walking exercises etc. It will be performed 3 days a week for 8 weeks. |
| Task-Oriented Approach Group | Active comparator | Other: Task-Oriented ApproachThe task-oriented approach for 60 minutes will be formed according to the needs of the individual and involve exercises targeting functional tasks determined. It will be performed 3 days a week for 8 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Unilateral stroke for more than 3 months
- Being over the age of 18
- Having trunk impairment (not having full points in the Trunk Impairment Scale)
- Being able to walk without support or with walking aid.
Key exclusion criteria (3 listed)
- Having recurrent stroke
- Having an orthopedic or neurological disorders other than stroke that may affect motor performance
- Having a cognitive problem (Not having Mini Mental State Examination score ≥ 24)
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 |
|---|---|---|
| Bobath MethodNeurodevelopmental Treatment | Other | Bobath Method Group |
| Task-Oriented ApproachTask-Oriented Treatment | Other | Task-Oriented Approach Group |
Primary outcome
Evaluation of Muscle Thickness with Ultrasonography
Time frame: change from baseline in muscle thickness of trunk muscles at 8 weeks
The evaluation of muscle thickness of bilateral rectus abdominis, external oblique, latissimus dorsi and erector spinae with ultrasonography will be performed by a physician using a 5-10 MHz linear probe (Diasus Dynamic Imaging Ltd, Livingston, Scotland,UK) in resting position. Muscle Thickness would be expressed as centimeters.
Evaluation of Muscle Activation with Superficial Electromyography
Time frame: change from baseline in muscle activation of trunk muscles at 8 weeks
The evaluation of muscle activation of bilateral rectus abdominis, external oblique, latissimus dorsi and erector spinae will be performed using Delsys Trigno Superficial Electromyography System during maximum voluntary isometric contraction, gait and balance performance.
Evaluation of Spatio-Temporal Parameters of Gait with GAITRite Analysis System
Time frame: change from baseline in spatio-temporal parameters of gait at 8 weeks
The evaluation of spatio-temporal parameters of gait such as velocity, cadence, step time, step length, gait cycle in double and single support, stance phase, swing phase, base of support, gait symmetry will be performed using the GAITRite electronic walkway.
Evaluation of Balance
Time frame: change from baseline in balance at 8 weeks
The evaluation of limits of stability, anteroposterior and mediolateral sway range will be performed using the Bertec Balance Check ScreenerTM force platform system.
3 secondary outcomes
Trunk Impairment Scale
Time frame: change from baseline in trunk performance at 8 weeks
Stroke Rehabilitation Assessment of Movement
Time frame: change from baseline in motor function at 8 weeks
Goal Attainment Scaling
Time frame: change in satisfaction regarding how to reach the goals related exercise therapy at 8 weeks
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 19 Apr 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bobath Method and Task-Oriented Approach in people with Stroke, 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 4 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 19 Apr 2023. 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?
Evaluation of Muscle Thickness with Ultrasonography (time frame: change from baseline in muscle thickness of trunk muscles at 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Apr 2023.