Effects of Sensory Training Application in Addition to Bobath Training

Stroke Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04753931
• Other study ID #: KaratayUOK
• Status: Completed
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: May 30, 2022

Study information

• Verified date: March 2022
• Source: KTO Karatay University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: May 30, 2022
• Est. primary completion date: May 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Stroke
• Stroke Rehabilitation

Intervention

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.
• 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.

Locations

Country	Name	City	State
Turkey	KTO Karatay University	Konya

Sponsors (1)

Lead Sponsor	Collaborator
KTO Karatay University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.