UnknownNot Applicable

The Effect of Rıgıd Brace on Spinopelvic Parameters and GAP Score in Adolescents With Structural Hyperkyphosis

Turkey (Türkiye)40 participantsStarted 2021-03-29

Plain-language summary

This study aimed to investigate the effect of rıgıd brace treatment on spinopelvic parameters and GAP score in patients with adolescent hyperkyphosis. This was a retrospective analysis of prospectively collected data. Thirty-two patients who were diagnosed with structural hyperkyphosis and treated with CAD-CAM design rigid brace were included in the study in Formed Healthcare Scoliosis Treatment and Brace Center between December 2015-2020.

Who can participate

Age range

10 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Subjects who diagnosed with Scheuermann's kyphosis or adolescent hyperkyphosis. * Inıtial curve magnitude between 55-75° * Patients who followed up at least 6 months * Patients who wearing CAD-CAM (Computer-Aided Design\&Computer-Aided Manufacturing) design TLSO(Thoraco-lumbo-sacral orthosis) kyphosis brace in 16 hours/day or more Exclusion Criteria: * History of spinal surgery or trauma * Patients has kyphosis due to congenital, neuromuscular, traumatic, tumor, infection causes * Ankylosing spondylitis and other spondyloarthropathies. * The lack of appropriate full-length lateral radiography with acceptable quality at the baseline or final assessment.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change from kyphosis angle at 6 months

Timeframe: 6 months after from beginning of study

Change from lordosis angle at 6 months

Timeframe: 6 months after from beginning of study

Change from the global tilt at 6 months

Timeframe: 6 months after from beginning of study

Change from Global Alignment and Proportion (GAP) score at 6 months

Timeframe: 6 months after from beginning

Trial details

NCT IDNCT04924556

SponsorHalic University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2021-06-14

Contact for this trial

Ahsen Büyükaslan, PhD(c)

905336992960 ahsen.buyukaslan@gmail.com

View on ClinicalTrials.gov More Hyperkyphosis, Adolescent trials

Plain-language summary

Who can participate

Age range

10 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change from kyphosis angle at 6 months

Timeframe: 6 months after from beginning of study

Change from lordosis angle at 6 months

Timeframe: 6 months after from beginning of study

Change from the global tilt at 6 months

Timeframe: 6 months after from beginning of study

Change from Global Alignment and Proportion (GAP) score at 6 months

Timeframe: 6 months after from beginning