NCT04523597

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2020

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

August 19, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 21, 2020

Completed
Last Updated

August 21, 2020

Status Verified

August 1, 2020

Enrollment Period

12 months

First QC Date

August 19, 2020

Last Update Submit

August 19, 2020

Conditions

Keywords

KyphosisPostural StabilityBiodex Balance SystemEquilibrium

Outcome Measures

Primary Outcomes (1)

  • 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 difficulty 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 Outcomes (10)

  • Visual Analog Scale

    the cases were evaluated once.

  • "Hand-held" dynamometer

    the cases were evaluated once.

  • Range of Motion

    the cases were evaluated once.

  • Triple-Hop Distance (THD) test

    the cases were evaluated once.

  • 20-m sprint test

    the cases were evaluated once.

  • +5 more secondary outcomes

Study Arms (2)

toracic hyperkyphosis

children with COBB angle ≥ 45˚

control

children with kyphosis index \< 13 measured using the flexicurve ruler

Eligibility Criteria

Age9 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University-Cerrapaşa, Faculty of Health Sciences

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Kyphosis

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • Nazlı Nacar

    Istanbul University-Cerrapaşa, Faculty of Health Sciences

    PRINCIPAL INVESTIGATOR
  • Ayşe Zengin Alpözgen

    Istanbul University-Cerrapaşa, Faculty of Health Sciences

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
physical therapist

Study Record Dates

First Submitted

August 19, 2020

First Posted

August 21, 2020

Study Start

February 1, 2019

Primary Completion

January 30, 2020

Study Completion

July 31, 2020

Last Updated

August 21, 2020

Record last verified: 2020-08

Locations