← Back to Search

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

CVBT Trial 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.Check my eligibility
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.See study design
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.

CVBT Trial 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.

CVBT Trial 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

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

CVBT 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
446 Previous Clinical Trials
879,062 Total Patients Enrolled
Orthopedic Research and Education FoundationOTHER
19 Previous Clinical Trials
10,960 Total Patients Enrolled
Pediatric Spine Study GroupUNKNOWN

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the most expansive size of subjects enrolled in this trial?

"Affirmative. Clinicaltrials.gov attests that this investigation is currently in search of participants, which was first listed on February 9th 2021 and recently edited on October 5th 2022. A total of 440 patients must be enrolled from 32 distinct medical centres for the study to proceed."

Answered by AI

Are there any vacancies for participants in this exploration?

"Yes, the clinical trial is currently in progress. According to information posted on clinicaltrials.gov, it began recruiting patients on February 9th 2021 and was last modified October 5th 2022. A total of 440 participants across 32 locations are required for this study."

Answered by AI

Is this medical study open to participants aged 55 and over?

"The appropriate candidates for this clinical trial must be within the range of 12 to 36 months old. There are currently 69 studies enrolling people under 18 years, and 14 with participants over 65."

Answered by AI

Are there any facilities in Canada presently conducting this research?

"There are 35 trial sites in total, including Riley's Hospital for Children at IU Healthcare in Indianapolis; the renowned Children's Hospital of Boston; and University of Michigan in Ann Arbor. There are an additional 32 locations participating as well."

Answered by AI

Could I be accepted to contribute to this medical research?

"This medical study is recruiting 440 infants aged between 12 months and 36 months with idiopathic scoliosis. Candidates must possess the capacity to stand independently (but not be older than 3 years of age), have a rib-vertebral angle difference greater than 20 degrees or a Rib Phase II, and an average Cobb Angle between 20° and 70°. Furthermore, both patients and their parents/guardians are required to provide consent for participation in this trial."

Answered by AI

Who else is applying?

What site did they apply to?
Shriners Hospitals for Children - Portland
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
Casting vs Bracing for Idiopathic Early-Onset Scoliosis
Stuart L. Weinstein, MD 2021. "Casting vs Bracing for Idiopathic Early-Onset Scoliosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04500041.
All > Scoliosis
~51 spots leftby Sep 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top