"Evaluation of Static and Dynamic Postural Balance in Children With Thoracic Hyperkyphosis"

Hyperkyphosis Clinical Trial

Official title:

"Evaluation of Static and Dynamic Postural Balance in Children With Thoracic Hyperkyphosis"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04523597
• Other study ID #: Istanbul University Cerrahpasa
• Status: Completed
• Start date: February 1, 2019
• Est. completion date: July 31, 2020

Study information

• Verified date: August 2020
• Source: Istanbul University-Cerrahpasa
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: July 31, 2020
• Est. primary completion date: January 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Hyperkyphosis
• Kyphosis

Locations

Country	Name	City	State
Turkey	Istanbul University-Cerrapasa, Faculty of Health Sciences	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University-Cerrahpasa

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biodex Balance System	Biodex Balance System is a valid instrument used to measure postural stability in static and dynamic conditions. The stability platform allows for varying levels of dif?culty of stability testing from level 1 (stabil) to level 12 (least stable). A high score is indicative of a lot of movement and indicates poor balance. In present study was assessed average Overall, AP, and ML stability scores under the following 4 position: right-leg static balance, left-leg static balance, bilateral static balance and bilateral dynamic balance at BBS level 8 (moderately unstable). Each position was applied with eyes open and closed.	the cases were evaluated once.
Secondary	Visual Analog Scale	Visual Analogue Scale will be use to assess pain. The scale consists of a horizontal line between 0-100mm. A value of 0 mm indicates "no pain" and a value of 100 mm indicates "the most severe". The severity of the pain that the patients feel in the back and neck regions during rest, activity and at night will be evaluated numerically.	the cases were evaluated once.
Secondary	"Hand-held" dynamometer	Maximal isometric contraction was evaluated with "Hand-held" dynamometer (Lafeyette Instrument®, Lafayette, IN) using a standard protocol and recorded in kg / Newton. In our study, strength of trunk flexion and extansion, upper-middle-lower trapesiuz, serratus anterior, latissimus dorsi, bilateral hip flexion, extansion, abduction, knee flexion, extansion and ankle plantarflexion, dorsiflexion were examined bilaterally.	the cases were evaluated once.
Secondary	Range of Motion	Goniometric measurement is an objectively used method in the evaluation of ROM in the clinic. In our study, trunk flexion, extansion and lateral flexion were measured with goniometer.	the cases were evaluated once.
Secondary	Triple-Hop Distance (THD) test	Triple-Hop Distance test is considered to be a valid and reliable test in evaluating the functional status as it is easy to apply and does not require much time and equipment. Participants performed 3 consecutive maximal hops forward on the right and left limb. It was measured with tape the distance hopped from the starting line to the point where the heel struck the ground upon completing the third hop. The maximum distance achieved during the 3 trials was recorded in centimeters and was used for analysis. High scores indicate that the functional condition is good.	the cases were evaluated once.
Secondary	20-m sprint test	20-m sprint test is used to evaluate the maximum running time of the participants. Maximal effort sprint was assessed from a stationary start. Participants was instructed to stand with one foot right behind the starting line and to accelerate at maximum effort to the finish line. The best value of 3 trials (minimal sprint time) with a 2 min rest between trials was used for further data analysis. Time was taken with a stop watch.	the cases were evaluated once.
Secondary	Physical Activity Questionnaire for Children	The physical activity level of the participants wasevaluated with the Physical Activity Questionnaire for Children , which is frequently used in the clinic. This questionnaire consists of 9 items in the 5-point Likert type that questions the physical activities performed in the last 7 days and how often these activities are performed. A high score on the scale indicates that the physical activity level is high.	the cases were evaluated once.
Secondary	Pediatric Quality of Life Inventory	Pediatric Quality of Life Inventory is a quality-of-life scale with validity and reliability of 23 items, which are frequently used in research to question the quality of life in children and adolescents. The higher the score obtained from the scale, the higher the quality of life increases.	the cases were evaluated once.
Secondary	Functional reach test	It measures the distance (using a tape at the level of the acromion) that an participants are able to reach forward and sides from a starting standing position with a fixed base of support without loss of balance. In our study, the distance to the forward and sides of the cases was tested. For each position were made 3 measurements and their average values were calculated. High scores indicate that the functional balance is good.	the cases were evaluated once.
Secondary	The occiput-wall distance	The occiput-wall distance is a surrogate measure of kyphosis.The method has been verified for its reliability and validity. Two rulers were used to quantify the outcomes: the first ruler was placed on the landmark (occiput), and the second ruler was used to measure a perpendicular distance from the first ruler (occiput) to the wall. The measurement was repeated for three trials with a period of rest as needed between the trials, and the average distance over the three trials was used for the data analysis. Higher values indicate an increase in kyphosis angle.	the cases were evaluated once.
Secondary	muscle flexibility of pektoralis minor	The patients were placed in the supine position with their forearms pronated on the side of the body, in this position the distance between the acromion and the bed was measured with a tape measure and the value was recorded in cm. High values indicate muscle shortness.	the cases were evaluated once.