Clinical trial NCT04523597: "Evaluation of Static and Dynamic Postural Balance in Children With Thoracic Hyperkyphosis"
Official title: "Evaluation of Static and Dynamic Postural Balance in Children With Thoracic Hyperkyphosis"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyperkyphosis
Keywords: Kyphosis
Postural Stability
Biodex Balance System
Equilibrium
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2020-08-21
Enrollment: 62
Sex: ALL
Minimum age (years): 9
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Children admitted to the orthopedics and Traumatology Outpatiant Clinic of Istanbul University, Istanbul Faculty of Medicine, and diagnosed with "thoracic Hypercyphosis" as a result of radiography evaluation.

Brief summary: The purpose of our study; is to investigate how balance parameters are affected in comparison with healthy children in children with thoracic hyperkyphosis and to examine the relationship of these results with muscle strength, shortness-flexibility, pain, range of motion, functional status, physical activity level and quality of life. The hypothesis of the study is that children with thoracic hyperkyphosis have impaired balance compared to their healthy peers. With this finding, it can be ensured that clinical evaluations and treatment strategies for balance in children with hyperkifosis are included in the treatment plan. 31 children with thoracic hyperkyphosis were included in the evaluation group, and 31 children with normal physiological curves were included in the control group. Participants were evaluated once by the physical therapist.

Detailed description: The study was included chidren with hyperkyphosis at the İstanbul University-Cerrahpaşa, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation. G\*Power 3.1.9.2 program was used to calculate the sample size. Due to the absence of MCID value for the Biodex Balance System in the literature while sample size calculation, the average values for males and females are 3.83 and 3.05 based on the "Overall Stability Index" based on the dominant side from a similar study conducted with healthy young adults; standard deviation values were placed in the formula as 1.03 and 1.13 (σ). (power=80%, α=0.05, significance level 2-tailed, and effect size d = 0.73). A total of 62 cases were decided to be included in the study, with 31 individuals per group. Participants were evaluated once by the physical therapist. Evaluation consist of demographic information form, Biodex Balance System, visual analog scale, "Hand-held" dynamometer, range of motion, pektoralis minor muscle flexibility, triple-hop distance test, 20-m sprint test, Physical Activity Questionnaire for Children, Pediatric Quality of Life Inventory, functional reach test and occiput-wall distance. SPSS (Statistical Package for Social Sciences) 22 statistical program was used for the statistical analysis of the data. Normality was assessed using the Shapiro-Wilk test. The "Chi-Square Test" was used to compare the difference between groups for categorical variables such as gender, dominant side, and educational status. The statistical analysis for group comparisons was performed using the "Mann-Whitney U Test" for non-parametric samples. Correlation analysis between the data was done with "Spearmann r Test". In all tests, a significance level of 0.05 (5%) was used.

Eligibility criteria: Inclusion Criteria:

* Thoracic kyphosis angle: ≥ 45˚ (Cobb)
* Age between 9-18 years
* Volunteering to participate in the study
* Not physiotherapy
* Not cest tretment

Exclusion Criteria:

* Spinal surgery history
* Vision and hearing impairment
* Difficulty in detecting commands given
* Lower extremity affect that may affect balance
* Systemic disorder associated with balance
* Neurological influence
* \> 20˚ (Cobb) scoliosis deformity

Primary outcomes:
measure: Biodex Balance System
timeFrame: the cases were evaluated once.
Secondary outcomes:
measure: Visual Analog Scale
timeFrame: the cases were evaluated once.
measure: "Hand-held" dynamometer
timeFrame: the cases were evaluated once.
measure: Range of Motion
timeFrame: the cases were evaluated once.
measure: Triple-Hop Distance (THD) test
timeFrame: the cases were evaluated once.
measure: 20-m sprint test
timeFrame: the cases were evaluated once.
measure: Physical Activity Questionnaire for Children
timeFrame: the cases were evaluated once.
measure: Pediatric Quality of Life Inventory
timeFrame: the cases were evaluated once.
measure: Functional reach test
timeFrame: the cases were evaluated once.
measure: The occiput-wall distance
timeFrame: the cases were evaluated once.
measure: muscle flexibility of pektoralis minor
timeFrame: the cases were evaluated once.
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrapaşa, Faculty of Health Sciences
Study officials:
affiliation: Istanbul University-Cerrapaşa, Faculty of Health Sciences
name: Nazlı Nacar
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul University-Cerrapaşa, Faculty of Health Sciences
name: Ayşe Zengin Alpözgen
role: STUDY_DIRECTOR
References: