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Casting vs bracing: which works best for kids with curved spines?

NCT ID NCT04500041

Disease control Sponsor: University of Iowa Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares two treatments—casting and bracing—for children under 3 with early-onset scoliosis. The goal is to see which method better controls spine curvature and improves quality of life. About 71 children and their parents are taking part.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could show which method—casting or bracing—better controls spine curvature in young children, potentially reducing the need for surgery.
What could go wrong
This is a small, early-stage trial with only 71 participants, so results may not apply to all children. Both treatments may fail to stop curve progression, and casting can be uncomfortable.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

71 people

The number who actually took part.

Started

Feb 2021

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 to 36 months

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Will enroll both patients with scoliosis and 1 of their parents/guardians Inclusion Criteria: Patient Inclusion * Diagnosis of idiopathic early-onset scoliosis * Child standing independently but not older than 3 years of age * 20≤ Cobb angle ≤70° (largest structural curvature) * Rib-vertebral angle difference (RVAD) greater than 20 degrees or Rib Phase II * Parental consent to participate Parent Inclusion * Parent or guardian of the minor subject * Consent to participate * Able to complete surveys Exclusion Criteria: Patient Exclusion * Previous operative or non-operative treatment for idiopathic early-onset scoliosis * Not independently walking by 18 months of age or other signs/symptoms indicative of developmental delay

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Conditions

The condition(s) this trial relates to.

idiopathic scoliosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Early-onset scoliosis deformity of spine Scoliosis idiopathic

Contacts and locations

Locations

  • Arkansas Children's Hospital

    Little Rock, Arkansas, 72202, United States

  • Children's Healthcare of Atlanta

    Atlanta, Georgia, 30342, United States

  • Children's Hospital Colorado

    Aurora, Colorado, 80045, United States

  • Children's Hospital of Boston

    Boston, Massachusetts, 02115, United States

  • Children's Hospital of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • Children's Mercy Kansas City

    Kansas City, Missouri, 64108, United States

  • Doernbecher Children's Hospital / OHSU

    Portland, Oregon, 97239, United States

  • Duke University Medical Center

    Durham, North Carolina, 27710, United States

  • Gillette Children's Specialty Healthcare

    Saint Paul, Minnesota, 55101, United States

  • Golisano Children's Hospital/University of Rochester

    Rochester, New York, 14642, United States

  • Italian Scientific Spine Institute (ISICO)

    Milan, Italy

  • Johns Hopkins

    Baltimore, Maryland, 21287, United States

  • Lurie Children's Hospital of Chicago

    Chicago, Illinois, 60611, United States

  • Nemours/Alfred I. duPont Hospital for Children

    Wilmington, Delaware, 19803, United States

  • Seattle Children's Hospital

    Seattle, Washington, 98105, United States

  • Shriners Hospitals for Children - Chicago

    Chicago, Illinois, 60707, United States

  • Shriners Hospitals for Children - Philadelphia

    Philadelphia, Pennsylvania, 19140, United States

  • Shriners Hospitals for Children - Portland

    Portland, Oregon, 97239, United States

  • St. Louis Children's Hospital/Washington University

    St Louis, Missouri, 63110, United States

  • Starship Child Health

    Auckland, New Zealand

  • Texas Children's Hospital

    Houston, Texas, 77030, United States

  • University of Iowa

    Iowa City, Iowa, 52242, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • University of North Carolina Chapel Hill

    Chapel Hill, North Carolina, 27514, United States

  • University of Virginia

    Charlottesville, Virginia, 22903, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.