- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04816929
The Effects of Bobath Method and Task-Oriented Approach in Stroke Patients
April 16, 2023 updated by: Gülşah Sütçü, Hacettepe University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Gülşah Sütçü, MSc
- Phone Number: +905547734223
- Email: gulsahsutcu92@gmail.com
Study Locations
-
-
Altındağ
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Ankara, Altındağ, Turkey, 06100
- Hacettepe University, Faculty of Physical Therapy and Rehabilitation
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Bobath Method Group
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.
|
Neurodevelopmental Treatment
|
Active Comparator: Task-Oriented Approach Group
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.
|
Task-Oriented Treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
change from baseline in muscle thickness of trunk muscles at 8 weeks
|
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.
|
change from baseline in muscle activation of trunk muscles at 8 weeks
|
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.
|
change from baseline in spatio-temporal parameters of gait at 8 weeks
|
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.
|
change from baseline in balance at 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Trunk Impairment Scale
Time Frame: change from baseline in trunk performance at 8 weeks
|
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.
|
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
|
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.
|
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
|
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.
|
change in satisfaction regarding how to reach the goals related exercise therapy at 8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 18, 2021
Primary Completion (Actual)
April 20, 2022
Study Completion (Actual)
April 20, 2022
Study Registration Dates
First Submitted
March 21, 2021
First Submitted That Met QC Criteria
March 24, 2021
First Posted (Actual)
March 25, 2021
Study Record Updates
Last Update Posted (Actual)
April 19, 2023
Last Update Submitted That Met QC Criteria
April 16, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KA-20063
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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