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Cranial Orthosis Therapy for Plagiocephaly: an RCT Pilot Study Comparing Cranial Orthosis to the Natural Course

NCT06173102 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-01-16

No results posted yet for this study

Summary

Our study aims to assess the feasibility of a randomized controlled trial that investigates the efficacy of cranial orthosis therapy for treating severe deformational plagiocephaly in infants between 4 and 7 months old.

The main question it aims to answer are:

• Feasibility of conducting the study in our physiatry clinic.

Participants will be randomized into two groups, receiving cranial orthosis at 1 week post initial visit, or the standard of care (7 weeks post initial visit). They will have head measurements and helmet adjustments as well as medical follow-up with a total of 4 visits. Post-treatment questionnaires will be filled out.

Conditions

  • Plagiocephaly
  • Plagiocephaly, Nonsynostotic
  • Plagiocephaly, Positional

Interventions

DEVICE

Cranial Orthosis

Early versus usual reception of orthosis.

Sponsors & Collaborators

  • St. Justine's Hospital

    lead OTHER

Principal Investigators

  • Camille Costa, MD · Université de Montréal, CHU Sainte-Justine

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
122 Days
Max Age
212 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-07
Primary Completion
2024-09-09
Completion
2024-09-09

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06173102 on ClinicalTrials.gov