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Procedure

Repositioning + Helmet Therapy for Flat Head Syndrome

N/A

Recruiting

Led By Tiffany Graham

Research Sponsored by University of Texas Southwestern Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Healthy infants with normal physical development and no need for physical therapy intervention

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10 months after enrollment (at 12 months of age)

Awards & highlights

Study Summary

This trial will study how effective repositioning and a special helmet are in treating a baby's misshapen head. Babies with torticollis will also get physical therapy. A comparison group of unaffected babies will be studied.

Who is the study for?

This trial is for healthy infants with normal development who have flat head syndrome or torticollis but don't need physical therapy. Infants with abnormal head shapes, growth abnormalities, genetic conditions, or significant developmental delays requiring therapy cannot participate.Check my eligibility

What is being tested?

The study tests how well caregiver-led repositioning helps correct an infant's cranial shape and the effectiveness of a custom-made cranial remolding orthosis. It includes infants with torticollis receiving physical therapy and compares their growth to unaffected peers.See study design

What are the potential side effects?

While not explicitly stated, potential side effects may include discomfort from wearing the orthosis or skin irritation at contact points. Repositioning has minimal risks but might require frequent attention from caregivers.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My infant is healthy with normal physical development and doesn't need physical therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10 months after enrollment (at 12 months of age)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~10 months after enrollment (at 12 months of age)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 months after enrollment (at 12 months of age) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Final Head Shape

Secondary outcome measures

Compliance with treatment

Overall Change in Head Shape

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Repositioning Therapy + Cranial Remolding OrthosesExperimental Treatment2 Interventions

After attempting at 2-4 months of repositioning therapy, infants with residual cranial deformation may be treated with a custom made helmet (cranial remolding orthosis) which is adjusted every few weeks to direct skull growth. It is worn 23 hours per day. Physical therapy will be provided, if indicated, for treatment of torticollis. This is a standard treatment.

Group II: Repositioning TherapyExperimental Treatment1 Intervention

Infants will be treated with at-home repositioning strategies for their deformational head shape. Physical therapy will be provided, if indicated, for treatment of torticollis. This is a standard treatment.

Group III: ControlActive Control1 Intervention

Healthy infants without deformational head shapes or need for physical therapy will be followed and measured. No intervention.

0 / 1Eligibility criteria met

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Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor

1,048 Previous Clinical Trials

1,053,670 Total Patients Enrolled

Children's HealthOTHER

7 Previous Clinical Trials

654 Total Patients Enrolled

Tiffany GrahamPrincipal InvestigatorUniversity of Texas Southwestern Medical Center

Media Library

Cranial Remolding Orthosis (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05917678 — N/A

Flat Head Syndrome Research Study Groups: Repositioning Therapy, Repositioning Therapy + Cranial Remolding Orthoses, Control

Flat Head Syndrome Clinical Trial 2023: Cranial Remolding Orthosis Highlights & Side Effects. Trial Name: NCT05917678 — N/A

Cranial Remolding Orthosis (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05917678 — N/A

Frequently Asked Questions

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

To whom is this experimental trial open?

"In order to join this trial, individuals should be diagnosed with torticollis and between the ages of 2-3 months old. Currently, 65 enrollees are required for complete recruitment."

Answered by AI

Does this research trial exclude adults of a certain age?

"Eligibility for this trial is contingent upon the participant's age. To be included in the trial, they must fall within a 2-3 month window. There are 12 studies dedicated to minors and 6 focusing on individuals over 65 years old."

Answered by AI

Is this research project currently open to participants?

"As indicated on clinicaltrials.gov, this trial has been ongoing since May 23rd 2023 and was last adjusted on June 14th of the same year. Recruitment efforts are still in full swing."

Answered by AI

What is the scope of individuals involved in this research endeavor?

"Confirmed. According to the data posted on clinicaltrials.gov, this medical study is actively searching for 65 participants from a single site and was first published on May 23rd 2023 with its most recent update being June 14th 2023."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Effectiveness of Repositioning and Cranial Remolding in Infants With Cranial Deformation

Tiffany Graham 2023. "Effectiveness of Repositioning and Cranial Remolding in Infants With Cranial Deformation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05917678.