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Effects of Sensory Training Application in Addition to Bobath Training

Primary Purpose

Stroke, Stroke Rehabilitation

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Sensory Training in addition to Bobath Training
Bobath Training
Sponsored by
KTO Karatay University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke Rehabilitation, Bobath, Trunk İmpairment

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Sub-acute (more than three months) and chronic stroke patients.
  • Patients are older than 18 years.
  • Patients who can sit and walk independently (including those using a walking aid).

Exclusion Criteria:

  • Patients with a total score of 20 or more on the trunk impairment scale.
  • Patients with additional neurological and/or orthopedic problems that may affect motor performance and balance.
  • Patients with mental problems (Mini-Mental State Examination test score <23).
  • Patients with communication problems.
  • Recurrent stroke patients.
  • Patients aged 85 years and over.

Sites / Locations

  • KTO Karatay University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Sensory Training in addition to Bobath Training

Bobath Training

Arm Description

Exercises will be applied to the individuals participating in the study 3 days a week, 8 weeks, and 24 sessions in total. Exercises will be applied after the conventional therapy sessions.

Exercises will be applied to the individuals participating in the study 3 days a week, 8 weeks, and 24 sessions in total. Exercises will be applied after the conventional therapy sessions.

Outcomes

Primary Outcome Measures

Trunk Impairment Scale
This scale aims to evaluate the trunk in patients who have suffered a stroke.
Trunk Impairment Scale
This scale aims to evaluate the trunk in patients who have suffered a stroke.
The Stroke Rehabilitation Assessment of Movement (STREAM)
STREAM is a measurement tool used to quantitatively evaluate the recovery of voluntary movement and mobility post stroke. The STREAM is used to assess patient's coordination, functional mobility and range of motion.
The Stroke Rehabilitation Assessment of Movement (STREAM)
STREAM is a measurement tool used to quantitatively evaluate the recovery of voluntary movement and mobility post stroke. The STREAM is used to assess patient's coordination, functional mobility and range of motion.
The Fugl-Meyer Assessment (FMA)
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia.
The Fugl-Meyer Assessment (FMA)
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia.
Berg Balance Scale
The Berg balance scale is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks.
Berg Balance Scale
The Berg balance scale is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks.
The Barthel Scale/Index (BI)
The Barthel Scale/Index (BI) is an ordinal scale used to measure performance in activities of daily living (ADL).
The Barthel Scale/Index (BI)
The Barthel Scale/Index (BI) is an ordinal scale used to measure performance in activities of daily living (ADL).
The Stroke Specific Quality of Life scale (SS-QOL)
The Stroke Specific Quality of Life scale (SS-QOL) is a patient-centered outcome measure intended to provide an assessment of health-related quality of life specific to patients with stroke.
The Stroke Specific Quality of Life scale (SS-QOL)
The Stroke Specific Quality of Life scale (SS-QOL) is a patient-centered outcome measure intended to provide an assessment of health-related quality of life specific to patients with stroke.
Functional Reach Test (FRT)
Functional Reach Test (FRT) is a clinical outcome measure and assessment tool for ascertaining dynamic balance in one simple task.
Functional Reach Test (FRT)
Functional Reach Test (FRT) is a clinical outcome measure and assessment tool for ascertaining dynamic balance in one simple task.
2 Minute Walk Test (2MWT)
The Two/2 Minute Walk Test (2MWT) is a measure of self-paced walking ability and functional capacity, particularly for those who cannot manage the longer Six Minute Walk Test (6MWT) or 12 Minute Walk Test.
2 Minute Walk Test (2MWT)
The Two/2 Minute Walk Test (2MWT) is a measure of self-paced walking ability and functional capacity, particularly for those who cannot manage the longer Six Minute Walk Test (6MWT) or 12 Minute Walk Test.
Mini-Mental State Examination
The Mini-mental state examination is used to measure cognitive impairment.
Trunk position sense measurements
Trunk position senses measurements will be made in trunk flexion and trunk rotation positions. The reposition error method measures the sense of position.
Trunk position sense measurements
Trunk position senses measurements will be made in trunk flexion and trunk rotation positions. The reposition error method measures the sense of position.

Secondary Outcome Measures

Full Information

First Posted
February 12, 2021
Last Updated
August 10, 2022
Sponsor
KTO Karatay University
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1. Study Identification

Unique Protocol Identification Number
NCT04753931
Brief Title
Effects of Sensory Training Application in Addition to Bobath Training
Official Title
Investigation of the Effects of Sensory Training Application in Addition to Bobath Training in Stroke Rehabilitation on Balance, Walking and Trunk Position Sensation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
May 15, 2022 (Actual)
Study Completion Date
May 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
KTO Karatay 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
The primary purpose of this study is to investigate the effects of sensory training, which will be applied to the trunk in addition to Bobath-based and trunk-focused exercises on trunk functions, sense, balance and gait. The secondary aim of the study is to investigate the effects of Bobath-based and trunk-focused exercises on trunk functional capacity, balance and gait performance. Our study consists of two groups: Bobath-based trunk training group and, sensory training group in addition to Bobath-based trunk training. The information of individuals who agree to participate in the study and meet the criteria for admission to the study will be recorded with a demographic information form. The scales, questionnaires and tests determined to evaluate the individual's trunk position sense and functions, balance and walking performance will be applied before and after the study.
Detailed Description
According to the definition of the World Health Organization, stroke is a clinical scene that develops due to vascular causes, causes focal or global brain damage, begins acutely, and progresses with neurological symptoms lasting 24 hours or longer. İt is stated that stroke is the third leading cause of disability worldwide. As a result of stroke, sensory disturbances may occur in individuals as well as motor symptoms. The primary purpose of this study is to investigate the effects of sensory training, which will be applied to the trunk in addition to Bobath-based and trunk-focused exercises on trunk functions, sense, balance and gait. The secondary aim of the study is to investigate the effects of Bobath-based and trunk-focused exercises on trunk functional capacity, balance and gait performance. Our study consists of two groups: Bobath-based trunk training group and, sensory training group in addition to Bobath-based trunk training. All participants will be randomly distributed (using software at http://www.randomizer.org). First, 12 patients will be included in our study and the total number of patients will be determined by calculating the effect size with the interm analysis to be performed later. Exercises will be applied to the individuals participating in the study 3 days a week, 8 weeks and 24 sessions in total. Exercises will be applied to the individuals after conventional therapy session. The information of individuals who agree to participate in the study and meet the criteria for admission to the study will be recorded with a demographic information form. The scales, questionnaires and tests determined to evaluate the individual's trunk position sense and functions, balance and walking performance will be applied before and after the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Stroke Rehabilitation
Keywords
Stroke Rehabilitation, Bobath, Trunk İmpairment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sensory Training in addition to Bobath Training
Arm Type
Experimental
Arm Description
Exercises will be applied to the individuals participating in the study 3 days a week, 8 weeks, and 24 sessions in total. Exercises will be applied after the conventional therapy sessions.
Arm Title
Bobath Training
Arm Type
Experimental
Arm Description
Exercises will be applied to the individuals participating in the study 3 days a week, 8 weeks, and 24 sessions in total. Exercises will be applied after the conventional therapy sessions.
Intervention Type
Other
Intervention Name(s)
Sensory Training in addition to Bobath Training
Intervention Description
Trunk-focused exercises will be applied for different senses (tactile, proprioceptive, etc.) in addition to Bobath exercises. Bobath exercises will be determined individually according to the evaluation results. In general, exercises aiming to muscle tone regulation, increase balance, walking, and functionality will be applied. Trunk-focused Bobath exercises will be selected.
Intervention Type
Other
Intervention Name(s)
Bobath Training
Intervention Description
Bobath exercises will be determined individually according to the evaluation results. In general, exercises aiming to muscle tone regulation, increase balance, walking, and functionality will be applied. Trunk-focused Bobath exercises will be selected.
Primary Outcome Measure Information:
Title
Trunk Impairment Scale
Description
This scale aims to evaluate the trunk in patients who have suffered a stroke.
Time Frame
The evaluation will be applied at the beginning of the treatment program.
Title
Trunk Impairment Scale
Description
This scale aims to evaluate the trunk in patients who have suffered a stroke.
Time Frame
The evaluation will be applied at the end of the 8 weeks treatment program.
Title
The Stroke Rehabilitation Assessment of Movement (STREAM)
Description
STREAM is a measurement tool used to quantitatively evaluate the recovery of voluntary movement and mobility post stroke. The STREAM is used to assess patient's coordination, functional mobility and range of motion.
Time Frame
The evaluation will be applied at the beginning of the treatment program.
Title
The Stroke Rehabilitation Assessment of Movement (STREAM)
Description
STREAM is a measurement tool used to quantitatively evaluate the recovery of voluntary movement and mobility post stroke. The STREAM is used to assess patient's coordination, functional mobility and range of motion.
Time Frame
The evaluation will be applied at the end of the 8 weeks treatment program.
Title
The Fugl-Meyer Assessment (FMA)
Description
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia.
Time Frame
The evaluation will be applied at the beginning of the treatment program.
Title
The Fugl-Meyer Assessment (FMA)
Description
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia.
Time Frame
The evaluation will be applied at the end of the 8 weeks treatment program.
Title
Berg Balance Scale
Description
The Berg balance scale is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks.
Time Frame
The evaluation will be applied at the beginning of the treatment program.
Title
Berg Balance Scale
Description
The Berg balance scale is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks.
Time Frame
The evaluation will be applied at the end of the 8 weeks treatment program.
Title
The Barthel Scale/Index (BI)
Description
The Barthel Scale/Index (BI) is an ordinal scale used to measure performance in activities of daily living (ADL).
Time Frame
The evaluation will be applied at the beginning of the treatment program.
Title
The Barthel Scale/Index (BI)
Description
The Barthel Scale/Index (BI) is an ordinal scale used to measure performance in activities of daily living (ADL).
Time Frame
The evaluation will be applied at the end of the 8 weeks treatment program.
Title
The Stroke Specific Quality of Life scale (SS-QOL)
Description
The Stroke Specific Quality of Life scale (SS-QOL) is a patient-centered outcome measure intended to provide an assessment of health-related quality of life specific to patients with stroke.
Time Frame
The evaluation will be applied at the beginning of the treatment program.
Title
The Stroke Specific Quality of Life scale (SS-QOL)
Description
The Stroke Specific Quality of Life scale (SS-QOL) is a patient-centered outcome measure intended to provide an assessment of health-related quality of life specific to patients with stroke.
Time Frame
The evaluation will be applied at the end of the 8 weeks treatment program.
Title
Functional Reach Test (FRT)
Description
Functional Reach Test (FRT) is a clinical outcome measure and assessment tool for ascertaining dynamic balance in one simple task.
Time Frame
The evaluation will be applied at the beginning of the treatment program.
Title
Functional Reach Test (FRT)
Description
Functional Reach Test (FRT) is a clinical outcome measure and assessment tool for ascertaining dynamic balance in one simple task.
Time Frame
The evaluation will be applied at the end of the 8 weeks treatment program.
Title
2 Minute Walk Test (2MWT)
Description
The Two/2 Minute Walk Test (2MWT) is a measure of self-paced walking ability and functional capacity, particularly for those who cannot manage the longer Six Minute Walk Test (6MWT) or 12 Minute Walk Test.
Time Frame
The evaluation will be applied at the beginning of the treatment program.
Title
2 Minute Walk Test (2MWT)
Description
The Two/2 Minute Walk Test (2MWT) is a measure of self-paced walking ability and functional capacity, particularly for those who cannot manage the longer Six Minute Walk Test (6MWT) or 12 Minute Walk Test.
Time Frame
The evaluation will be applied at the end of the 8 weeks treatment program.
Title
Mini-Mental State Examination
Description
The Mini-mental state examination is used to measure cognitive impairment.
Time Frame
The evaluation will be applied at the beginning of the treatment program.
Title
Trunk position sense measurements
Description
Trunk position senses measurements will be made in trunk flexion and trunk rotation positions. The reposition error method measures the sense of position.
Time Frame
The evaluation will be applied at the beginning of the treatment program.
Title
Trunk position sense measurements
Description
Trunk position senses measurements will be made in trunk flexion and trunk rotation positions. The reposition error method measures the sense of position.
Time Frame
The evaluation will be applied at the end of the 8 weeks treatment program.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Sub-acute (more than three months) and chronic stroke patients. Patients are older than 18 years. Patients who can sit and walk independently (including those using a walking aid). Exclusion Criteria: Patients with a total score of 20 or more on the trunk impairment scale. Patients with additional neurological and/or orthopedic problems that may affect motor performance and balance. Patients with mental problems (Mini-Mental State Examination test score <23). Patients with communication problems. Recurrent stroke patients. Patients aged 85 years and over.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Osman Karaca, M.Sc.
Organizational Affiliation
KTO Karatay University
Official's Role
Study Chair
Facility Information:
Facility Name
KTO Karatay University
City
Konya
Country
Turkey

12. IPD Sharing Statement

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Effects of Sensory Training Application in Addition to Bobath Training

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