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Completed

NCT Number: NCT04753931

Effects of Sensory Training Application in Addition to Bobath Training

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Rehabilitation Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

KTO Karatay University

Konya, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sensory Training in addition to Bobath Training

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

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.

Primary outcomes

  1. Trunk Impairment Scale

    Time frame: The evaluation will be applied at the beginning of the treatment program.

    This scale aims to evaluate the trunk in patients who have suffered a stroke.

  2. Trunk Impairment Scale

    Time frame: 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.

  3. The Stroke Rehabilitation Assessment of Movement (STREAM)

    Time frame: The evaluation will be applied at the beginning of the 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.

  4. The Stroke Rehabilitation Assessment of Movement (STREAM)

    Time frame: 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.

  5. The Fugl-Meyer Assessment (FMA)

    Time frame: The evaluation will be applied at the beginning of the 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.

  6. The Fugl-Meyer Assessment (FMA)

    Time frame: 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.

  7. Berg Balance Scale

    Time frame: The evaluation will be applied at the beginning of the 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.

  8. Berg Balance Scale

    Time frame: 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.

  9. The Barthel Scale/Index (BI)

    Time frame: The evaluation will be applied at the beginning of the treatment program.

    The Barthel Scale/Index (BI) is an ordinal scale used to measure performance in activities of daily living (ADL).

  10. The Barthel Scale/Index (BI)

    Time frame: 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).

  11. The Stroke Specific Quality of Life scale (SS-QOL)

    Time frame: The evaluation will be applied at the beginning of the 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.

  12. The Stroke Specific Quality of Life scale (SS-QOL)

    Time frame: 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.

  13. Functional Reach Test (FRT)

    Time frame: The evaluation will be applied at the beginning of the treatment program.

    Functional Reach Test (FRT) is a clinical outcome measure and assessment tool for ascertaining dynamic balance in one simple task.

  14. Functional Reach Test (FRT)

    Time frame: 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.

  15. 2 Minute Walk Test (2MWT)

    Time frame: The evaluation will be applied at the beginning of the 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.

  16. 2 Minute Walk Test (2MWT)

    Time frame: 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.

  17. Mini-Mental State Examination

    Time frame: The evaluation will be applied at the beginning of the treatment program.

    The Mini-mental state examination is used to measure cognitive impairment.

  18. Trunk position sense measurements

    Time frame: The evaluation will be applied at the beginning of the 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.

  19. Trunk position sense measurements

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

KTO Karatay University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 15, 2021
Registry last updated
Oct 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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