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Casting vs Bracing for Scoliosis (CVBT Trial)

N/A
Recruiting
Led By Stuart L Weinstein, MD
Research Sponsored by University of Iowa
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of idiopathic early-onset scoliosis
Child standing independently but not older than 3 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up on or before 24 months of treatment
Awards & highlights
No Placebo-Only Group

Summary

This trial compares casting and bracing for the treatment of scoliosis.

Who is the study for?
This trial is for children under 3 who can stand on their own and have been diagnosed with idiopathic early-onset scoliosis, showing a Cobb angle between 20° to 70°. A parent or guardian must consent to the child's participation. Children with conditions that don't meet these specific criteria are excluded.
What is being tested?
The study compares two methods of treating young children with scoliosis: one group will receive treatment through casting while another will use bracing. The goal is to see which method is more effective in managing this condition.
What are the potential side effects?
Possible side effects from casting or bracing may include skin irritation, discomfort, restricted movement, and potential impact on breathing due to pressure on the chest.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with scoliosis that started without a known cause when I was young.
Select...
My child can stand on their own and is under 3 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~on or before 24 months of treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and on or before 24 months of treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Curve Response
Secondary study objectives
Patient Health-related Quality of Life (HRQOL)
Other study objectives
Parent and Family Functioning

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: BracingActive Control1 Intervention
Subjects will be treated with full-time orthotics (braces)
Group II: CastingActive Control1 Intervention
Subjects will be treated with serial casting

Find a Location

Who is running the clinical trial?

University of IowaLead Sponsor
471 Previous Clinical Trials
894,620 Total Patients Enrolled
Orthopedic Research and Education FoundationOTHER
20 Previous Clinical Trials
5,230 Total Patients Enrolled
Pediatric Spine Study GroupUNKNOWN
Stuart L Weinstein, MDPrincipal InvestigatorUniversity of Iowa

Media Library

Bracing Clinical Trial Eligibility Overview. Trial Name: NCT04500041 — N/A
Early-Onset Scoliosis Research Study Groups: Bracing, Casting
Early-Onset Scoliosis Clinical Trial 2023: Bracing Highlights & Side Effects. Trial Name: NCT04500041 — N/A
Bracing 2023 Treatment Timeline for Medical Study. Trial Name: NCT04500041 — N/A
~91 spots leftby Dec 2025
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