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The Effects of Bobath Method and Task-Oriented Approach in Stroke Patients

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Bobath Method
Task-Oriented Approach
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Cerebrovascular Disorders, Trunk, Muscle Thickness, Ultrasonography, Muscle Activation, Electromyography, Gait, Balance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Hacettepe University, Faculty of Physical Therapy and Rehabilitation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Bobath Method Group

Task-Oriented Approach Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
March 21, 2021
Last Updated
April 16, 2023
Sponsor
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT04816929
Brief Title
The Effects of Bobath Method and Task-Oriented Approach in Stroke Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
January 18, 2021 (Actual)
Primary Completion Date
April 20, 2022 (Actual)
Study Completion Date
April 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Cerebrovascular Disorders, Trunk, Muscle Thickness, Ultrasonography, Muscle Activation, Electromyography, Gait, Balance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bobath Method Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Task-Oriented Approach Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Bobath Method
Intervention Description
Neurodevelopmental Treatment
Intervention Type
Other
Intervention Name(s)
Task-Oriented Approach
Intervention Description
Task-Oriented Treatment
Primary Outcome Measure Information:
Title
Evaluation of Muscle Thickness with Ultrasonography
Description
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.
Time Frame
change from baseline in muscle thickness of trunk muscles at 8 weeks
Title
Evaluation of Muscle Activation with Superficial Electromyography
Description
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.
Time Frame
change from baseline in muscle activation of trunk muscles at 8 weeks
Title
Evaluation of Spatio-Temporal Parameters of Gait with GAITRite Analysis System
Description
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.
Time Frame
change from baseline in spatio-temporal parameters of gait at 8 weeks
Title
Evaluation of Balance
Description
The evaluation of limits of stability, anteroposterior and mediolateral sway range will be performed using the Bertec Balance Check ScreenerTM force platform system.
Time Frame
change from baseline in balance at 8 weeks
Secondary Outcome Measure Information:
Title
Trunk Impairment Scale
Description
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.
Time Frame
change from baseline in trunk performance at 8 weeks
Title
Stroke Rehabilitation Assessment of Movement
Description
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.
Time Frame
change from baseline in motor function at 8 weeks
Title
Goal Attainment Scaling
Description
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.
Time Frame
change in satisfaction regarding how to reach the goals related exercise therapy at 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Hacettepe University, Faculty of Physical Therapy and Rehabilitation
City
Ankara
State/Province
Altındağ
ZIP/Postal Code
06100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Effects of Bobath Method and Task-Oriented Approach in Stroke Patients

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