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Procedure

Early Cranial Orthosis for Flat Head Syndrome

N/A
Recruiting
Led By Camille Costa, MD
Research Sponsored by St. Justine's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must have a clinical diagnosis of severe deformational plagiocephaly by a physiatrist based on clinical evaluation and confirmed by anthropometric measurements with a spreading caliper and 3D-scan.
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at week 0, week 6 and week 12
Awards & highlights

Study Summary

This trial studies the effect of cranial orthosis therapy to treat head shape deformations in infants 4-7 months old. Patients will be assigned to one of two groups and monitored over 4 visits for results.

Who is the study for?
This trial is for infants aged between 4 and 7 months with severe deformational plagiocephaly, commonly known as flat head syndrome. The study will take place in a physiatry clinic, and participants must be able to attend four medical visits.Check my eligibility
What is being tested?
The study tests the effectiveness of cranial orthosis therapy (a type of helmet) for treating flat head syndrome. Infants are randomly placed into two groups: one receives the helmet at 1 week after their first visit, while the other at 7 weeks.See study design
What are the potential side effects?
While not explicitly mentioned, potential side effects may include discomfort from wearing the helmet, skin irritation under the device, or difficulty in adjusting to it during sleep.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with severe skull shape irregularity by a specialist.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at week 0, week 6 and week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and at week 0, week 6 and week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Qualitative information on Feasibility
Secondary outcome measures
Adverse Effects
Cranial Vault Asymmetry (CVA)
Cranial Vault Asymmetry Index (CVAI)
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Usual Cranial OrthosisExperimental Treatment1 Intervention
Usual cranial orthosis (reception 7 weeks after initial visit)
Group II: Early Cranial OrthosisExperimental Treatment1 Intervention
Early cranial orthosis (reception 1 week after initial visit)

Find a Location

Who is running the clinical trial?

St. Justine's HospitalLead Sponsor
196 Previous Clinical Trials
79,005 Total Patients Enrolled
Camille Costa, MDPrincipal InvestigatorUniversité de Montréal, CHU Sainte-Justine

Frequently Asked Questions

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

How numerous are the individuals participating in this clinical experiment?

"Affirmative. Clinicaltrials.gov provides evidence that this research project began recruiting on December 7th, 2023 and is still actively doing so at the time of writing. 24 individuals need to be enrolled from a single centre for the trial to reach completion."

Answered by AI

Are any participants of this trial aged 75 or over?

"This clinical trial seeks to include individuals between the ages of 122 days and 212 days."

Answered by AI

Are additional volunteers being sought for this medical experiment?

"Affirmative. According to clinicaltrials.gov, this medical endeavour is currently recruiting participants and was last updated on December 7th 2023. 24 individuals need to be enrolled across 1 facility for successful completion of the project."

Answered by AI

What are the qualifications needed for a person to be eligible for this research endeavor?

"This trial is in need of 24 participants that have positional plagiocephaly and are between 122 days to 212 days old."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Cranial Orthosis Therapy for Plagiocephaly: an RCT Pilot Study Comparing Cranial Orthosis to the Natural Course
Camille Costa 2023. "Cranial Orthosis Therapy for Plagiocephaly: an RCT Pilot Study Comparing Cranial Orthosis to the Natural Course". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06173102.
~13 spots leftby Oct 2024
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