NCT04805437 Brace Treatment for Idiopathic Scoliosis; PReventing Idiopathic SCOliosis PROgression
| NCT ID | NCT04805437 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Karolinska Institutet |
| Condition | Idiopathic Scoliosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 170 participants |
| Start Date | 2021-04-30 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 170 participants in total. It began in 2021-04-30 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Cobb 25-40 degrees * Skeletally immature, Sanders score of 6 or less and Risser 2 or less. * Menarche status maximum one year in females * Aged 9-17 years * No previous brace treatment or surgery for scoliosis * Apex of the primary curve at T7 or caudal Exclusion Criteria: * Non-idiopathic scoliosis (i.e. neuromuscular, syndromic or congenital scoliosis) * Previous spine surgery
Contact & Investigator
Elias Diarbakerli, PT, PhD
PRINCIPAL INVESTIGATOR
Karolinska Institutet
Frequently Asked Questions
Who can join the NCT04805437 clinical trial?
This trial is open to participants of all sexes, aged 9 Years or older, up to 17 Years, studying Idiopathic Scoliosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04805437 currently recruiting?
Yes, NCT04805437 is actively recruiting participants. Contact the research team at elias.diarbakerli@sll.se for enrollment information.
Where is the NCT04805437 trial being conducted?
This trial is being conducted at Linköping, Sweden, Stockholm, Sweden.
Who is sponsoring the NCT04805437 clinical trial?
NCT04805437 is sponsored by Karolinska Institutet. The principal investigator is Elias Diarbakerli, PT, PhD at Karolinska Institutet. The trial plans to enroll 170 participants.