Actively Recruiting

Phase Not Applicable
Age: 9Years - 17Years
All Genders
NCT04805437

Brace Treatment for Idiopathic Scoliosis; PReventing Idiopathic SCOliosis PROgression

Led by Karolinska Institutet · Updated on 2025-02-21

170

Participants Needed

2

Research Sites

830 weeks

Total Duration

On this page

Sponsors

K

Karolinska Institutet

Lead Sponsor

L

Linkoeping University

Collaborating Sponsor

AI-Summary

What this Trial Is About

Idiopathic scoliosis is the most common spinal deformity in children and adolescents with an estimated prevalence of 3%. About one tenth of the children with scoliosis develop a deformity that requires treatment with brace or surgery with the current treatment protocol. When brace treatment for scoliosis is indicated, standard treatment consists of bracing 20 hours or more per day. Outcomes of brace treatment depend to a large extent on wearing time and since many adolescents feel uncomfortable in the brace, it is of importance to combine efficacy and comfortability of the brace.

CONDITIONS

Official Title

Brace Treatment for Idiopathic Scoliosis; PReventing Idiopathic SCOliosis PROgression

Who Can Participate

Age: 9Years - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 9 to 17 years
  • Diagnosed with idiopathic scoliosis with a Cobb angle between 25 and 40 degrees
  • Skeletally immature with Sanders score of 6 or less and Risser score of 2 or less
  • Females with menarche status not more than one year
  • No previous brace treatment or surgery for scoliosis
  • Primary curve apex located at vertebra T7 or below
Not Eligible

You will not qualify if you...

  • Having non-idiopathic scoliosis such as neuromuscular, syndromic, or congenital scoliosis
  • Previous spine surgery

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

Linköping university hospital

Linköping, Sweden

Not Yet Recruiting

2

Karolinska university hospital

Stockholm, Sweden

Actively Recruiting

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Research Team

E

Elias Diarbakerli, PT, PhD

CONTACT

P

Paul Gerdhem, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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