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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
    • Altındağ
      • Ankara, Altındağ, Turkey, 06100
        • Hacettepe University, Faculty of Physical Therapy and Rehabilitation

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Bobath Method
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.
Other: Task-Oriented Approach
Task-Oriented Treatment

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hacettepe University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 18, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 20, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 20, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 21, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 19, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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