Effects of Sensory Training Application in Addition to Bobath Training

Investigation of the Effects of Sensory Training Application in Addition to Bobath Training in Stroke Rehabilitation on Balance, Walking and Trunk Position Sensation

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Stroke Rehabilitation
• Intervention / Treatment: Other: Sensory Training in addition to Bobath Training; Other: Bobath Training

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.

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Konya, Turkey
    • KTO Karatay University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sensory Training in addition to Bobath Training; 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.	Other: Sensory Training in addition to Bobath Training; 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.
Experimental: Bobath Training; 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.	Other: Bobath Training; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Trunk Impairment Scale	This scale aims to evaluate the trunk in patients who have suffered a stroke.	The evaluation will be applied at the beginning of the treatment program.
Trunk Impairment Scale	This scale aims to evaluate the trunk in patients who have suffered a stroke.	The evaluation will be applied at the end of the 8 weeks treatment program.
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 evaluation will be applied at the beginning of the treatment program.
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 evaluation will be applied at the end of the 8 weeks treatment program.
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 evaluation will be applied at the beginning of the treatment program.
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 evaluation will be applied at the end of the 8 weeks treatment program.
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 evaluation will be applied at the beginning of the treatment program.
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 evaluation will be applied at the end of the 8 weeks treatment program.
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 evaluation will be applied at the beginning of the treatment program.
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 evaluation will be applied at the end of the 8 weeks treatment program.
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 evaluation will be applied at the beginning of the treatment program.
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 evaluation will be applied at the end of the 8 weeks treatment program.
Functional Reach Test (FRT)	Functional Reach Test (FRT) is a clinical outcome measure and assessment tool for ascertaining dynamic balance in one simple task.	The evaluation will be applied at the beginning of the treatment program.
Functional Reach Test (FRT)	Functional Reach Test (FRT) is a clinical outcome measure and assessment tool for ascertaining dynamic balance in one simple task.	The evaluation will be applied at the end of the 8 weeks treatment program.
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.	The evaluation will be applied at the beginning of the treatment program.
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.	The evaluation will be applied at the end of the 8 weeks treatment program.
Mini-Mental State Examination	The Mini-mental state examination is used to measure cognitive impairment.	The evaluation will be applied at the beginning of the treatment program.
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.	The evaluation will be applied at the beginning of the treatment program.
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.	The evaluation will be applied at the end of the 8 weeks treatment program.

Collaborators and Investigators

• Sponsor: KTO Karatay University
• Investigators: Study Chair: Osman Karaca, M.Sc., KTO Karatay University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): May 15, 2022
• Study Completion (Actual): May 30, 2022

Study Registration Dates

• First Submitted: February 12, 2021
• First Submitted That Met QC Criteria: February 12, 2021
• First Posted (Actual): February 15, 2021

Study Record Updates

• Last Update Posted (Actual): October 31, 2023
• Last Update Submitted That Met QC Criteria: October 27, 2023
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Stroke Rehabilitation; Bobath; Trunk İmpairment
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: KaratayUOK

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No