NCT07117448

Brief Summary

The goal of this observational study is to evaluate the relationship between sagittal and spinopelvic radiological parameters of the spine and clinical outcomes in adolescents with Scheuermann's kyphosis (SK) by assessing dynamic and static balance, pain, quality of life, and body image. The main questions it aims to answer are: Is there a correlation between kyphosis severity, spinopelvic measurements, and balance scores in adolescents with Scheuermann's kyphosis? How do pain, body image, and quality of life relate to radiological parameters and clinical findings in these individuals? Are there significant differences in balance, spinopelvic parameters, body image, and quality of life between adolescents with Scheuermann's kyphosis and healthy controls? Participants will undergo radiological evaluation of sagittal spine and spinopelvic parameters using standing lateral spinal radiographs, static and dynamic balance assessments to evaluate postural stability, pain assessment using validated pain scales, and quality of life and body image assessments through standardized questionnaires. Researchers will compare Scheuermann's kyphosis patients and age-matched healthy controls to determine the impact of kyphosis severity on balance, body image, and quality of life.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2024

Shorter than P25 for all trials

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

October 10, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 18, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 12, 2025

Completed
Last Updated

August 12, 2025

Status Verified

August 1, 2025

Enrollment Period

5 months

First QC Date

June 18, 2025

Last Update Submit

August 4, 2025

Conditions

Keywords

KyphosisBalanceSagittal balanceSpinopelvic parametersScheuermann Disease

Outcome Measures

Primary Outcomes (1)

  • Balance Parameters Assessed by Multiple Modalities

    Clinical balance tests will assess static postural control by recording the duration (in seconds) the participant maintains the test position. Stabilometric platform will measure postural sway parameters during quiet stance. Computerized Dynamic Posturography (CDP) will provide composite scores reflecting balance performance under various sensory conditions Each method will be analyzed and reported separately. Additionally, agreement and correlation between clinical balance tests and device-based measurements (stabilometric platform and CDP) will be evaluated.

    At enrollment (Day 0, cross-sectional)

Secondary Outcomes (4)

  • Pain Level Assessed by Numeric Rating Scale (NRS)

    At enrollment (Day 0)

  • Health-Related Quality of Life Assessed by SRS-22r

    At enrollment (Day 0)

  • Body Image Perception Assessed by SAAS

    At enrollment (Day 0)

  • Correlation Between Clinical and Radiological Parameters

    At enrollment (Day 0)

Study Arms (2)

Scheuermann's Kyphosis Group

Adolescents diagnosed with Scheuermann's kyphosis according to Sorensen criteria

Healthy Control Group

Age- and sex-matched healthy adolescents with no spinal deformity

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Adolescents aged 10 to 18 years, including individuals diagnosed with Scheuermann's kyphosis and age- and sex-matched healthy controls. All participants were recruited from the department of physical medicine and rehabilitation

You may qualify if:

  • Adolescents aged 10 to 18 years
  • Diagnosis of Scheuermann's kyphosis based on Sorensen criteria (for patient group)
  • Healthy volunteers matched for age and sex (for control group)
  • Ability to understand and comply with study procedures
  • Informed consent obtained from participants and/or guardians

You may not qualify if:

  • Neuromuscular disorders
  • History of spinal surgery or traumatic spinal injury
  • Scoliosis \> 15° (Cobb angle)
  • Vestibular, visual, or auditory impairments
  • Lower extremity musculoskeletal disorders affecting gait or balance
  • Cognitive or psychiatric conditions affecting participation
  • Use of orthotic devices or braces
  • Any other systemic condition affecting postural control

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fatih Sultan Mehmet Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Scheuermann DiseaseKyphosis

Condition Hierarchy (Ancestors)

Spinal OsteochondrosisOsteochondrosisBone DiseasesMusculoskeletal DiseasesSpinal CurvaturesSpinal Diseases

Study Officials

  • sılanur güney çamlıca, medical doctor

    Resident University of Health Sciences, FSM Training and Research Hospital, Istanbul

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
8 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

June 18, 2025

First Posted

August 12, 2025

Study Start

October 10, 2024

Primary Completion

March 10, 2025

Study Completion

May 10, 2025

Last Updated

August 12, 2025

Record last verified: 2025-08

Locations