Clinical trial NCT04753931: Effects of Sensory Training Application in Addition to Bobath Training
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Stroke Rehabilitation
Keywords: Stroke Rehabilitation
Bobath
Trunk İmpairment
Lead sponsor: KTO Karatay University
Sponsor class: OTHER
First posted: 2021-02-15
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Trunk Impairment Scale
timeFrame: The evaluation will be applied at the beginning of the treatment program.
measure: Trunk Impairment Scale
timeFrame: The evaluation will be applied at the end of the 8 weeks treatment program.
measure: The Stroke Rehabilitation Assessment of Movement (STREAM)
timeFrame: The evaluation will be applied at the beginning of the treatment program.
measure: The Stroke Rehabilitation Assessment of Movement (STREAM)
timeFrame: The evaluation will be applied at the end of the 8 weeks treatment program.
measure: The Fugl-Meyer Assessment (FMA)
timeFrame: The evaluation will be applied at the beginning of the treatment program.
measure: The Fugl-Meyer Assessment (FMA)
timeFrame: The evaluation will be applied at the end of the 8 weeks treatment program.
measure: Berg Balance Scale
timeFrame: The evaluation will be applied at the beginning of the treatment program.
measure: Berg Balance Scale
timeFrame: The evaluation will be applied at the end of the 8 weeks treatment program.
measure: The Barthel Scale/Index (BI)
timeFrame: The evaluation will be applied at the beginning of the treatment program.
measure: The Barthel Scale/Index (BI)
timeFrame: The evaluation will be applied at the end of the 8 weeks treatment program.
measure: The Stroke Specific Quality of Life scale (SS-QOL)
timeFrame: The evaluation will be applied at the beginning of the treatment program.
measure: The Stroke Specific Quality of Life scale (SS-QOL)
timeFrame: The evaluation will be applied at the end of the 8 weeks treatment program.
measure: Functional Reach Test (FRT)
timeFrame: The evaluation will be applied at the beginning of the treatment program.
measure: Functional Reach Test (FRT)
timeFrame: The evaluation will be applied at the end of the 8 weeks treatment program.
measure: 2 Minute Walk Test (2MWT)
timeFrame: The evaluation will be applied at the beginning of the treatment program.
measure: 2 Minute Walk Test (2MWT)
timeFrame: The evaluation will be applied at the end of the 8 weeks treatment program.
measure: Mini-Mental State Examination
timeFrame: The evaluation will be applied at the beginning of the treatment program.
measure: Trunk position sense measurements
timeFrame: The evaluation will be applied at the beginning of the treatment program.
measure: Trunk position sense measurements
timeFrame: The evaluation will be applied at the end of the 8 weeks treatment program.
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: KTO Karatay University
Study officials:
affiliation: KTO Karatay University
name: Osman Karaca, M.Sc.
role: STUDY_CHAIR
References: