Effects of Sensory Training Application in Addition to Bobath Training

Not Applicable

Completed

• Conditions: Stroke; Stroke Rehabilitation
• Interventions: Other: Bobath Training; Other: Sensory Training in addition to Bobath Training

• Registration Number: NCT04753931
• Lead Sponsor: KTO Karatay University

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.

Study Timeline

• Study First Submitted: 2021-02-12
• Study First Submitted QC: 2021-02-12
• Study First Posted: 2021-02-15
• Study Start: 2021-03-01
• Status Verified: 2022-03
• Primary Completion: 2022-05-15
• Study Completion: 2022-05-30
• Last Update Submitted: 2023-10-27
• Last Update Posted: 2023-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bobath Training	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.
Sensory Training in addition to Bobath Training	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.

Primary Outcome Measures

Name	Time	Method
Berg Balance Scale	The evaluation will be applied at the end of the 8 weeks treatment program.	The Berg balance scale is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks.
Mini-Mental State Examination	The evaluation will be applied at the beginning of the treatment program.	The Mini-mental state examination is used to measure cognitive impairment.
Trunk Impairment Scale	The evaluation will be applied at the end of the 8 weeks treatment program.	This scale aims to evaluate the trunk in patients who have suffered a stroke.
The Fugl-Meyer Assessment (FMA)	The evaluation will be applied at the end of the 8 weeks treatment program.	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 Barthel Scale/Index (BI)	The evaluation will be applied at the end of the 8 weeks treatment program.	The Barthel Scale/Index (BI) is an ordinal scale used to measure performance in activities of daily living (ADL).
Functional Reach Test (FRT)	The evaluation will be applied at the end of the 8 weeks treatment program.	Functional Reach Test (FRT) is a clinical outcome measure and assessment tool for ascertaining dynamic balance in one simple task.
The Stroke Rehabilitation Assessment of Movement (STREAM)	The evaluation will be applied at the end of the 8 weeks treatment program.	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.
2 Minute Walk Test (2MWT)	The evaluation will be applied at the end of the 8 weeks treatment program.	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 Stroke Specific Quality of Life scale (SS-QOL)	The evaluation will be applied at the end of the 8 weeks treatment program.	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.
Trunk position sense measurements	The evaluation will be applied at the end of the 8 weeks treatment program.	Trunk position senses measurements will be made in trunk flexion and trunk rotation positions. The reposition error method measures the sense of position.

Trial Locations

Locations (1)

KTO Karatay University; 🇹🇷 Konya, Turkey