Effects of Sensory Training Application in Addition to Bobath Training

NCT04753931 | Completed

• 1 other identifier: KaratayUOK
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Stroke Rehabilitation

Keywords

Stroke Rehabilitation; Bobath; Trunk İmpairment

Outcome Measures

Primary Outcomes (19)

• 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.

Study Arms (2)

Sensory Training in addition to Bobath Training

EXPERIMENTAL

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

Bobath Training

EXPERIMENTAL

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

Interventions

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.

Sensory Training in addition to Bobath Training

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.

Bobath Training

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• KTO Karatay University: lead

Study Sites (1)

KTO Karatay University

Konya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Osman Karaca, M.Sc.

  KTO Karatay University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: single-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2021
• First Posted: February 15, 2021
• Study Start: March 1, 2021
• Primary Completion: May 15, 2022
• Study Completion: May 30, 2022
• Last Updated: October 31, 2023

Record last verified: 2022-03

Locations

TU (1)