Effects of Sensory Training Application in Addition to Bobath Training

NCT ID: NCT04753931

Last Updated: 2023-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2022-05-30

Brief Summary

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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

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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.

Conditions

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Stroke Stroke Rehabilitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
single-blind

Study Groups

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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.

Group Type EXPERIMENTAL

Sensory Training in addition to Bobath Training

Intervention Type OTHER

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.

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.

Group Type EXPERIMENTAL

Bobath Training

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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KTO Karatay University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Osman Karaca, M.Sc.

Role: STUDY_CHAIR

KTO Karatay University

Locations

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KTO Karatay University

Konya, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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KaratayUOK

Identifier Type: -

Identifier Source: org_study_id

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