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

Plagiocephaly Clinical Trial

Official title: Treatment Effectiveness of Cranial Orthosis Therapy in the Correction of Deformational Plagiocephaly: a Randomized Controlled Pilot Study Comparing Cranial Orthosis Therapy to the Natural Course

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

Our research endeavors to examine the feasibility of implementing a randomized controlled trial (RCT) that evaluates the efficacy of cranial orthosis therapy in addressing severe deformational plagiocephaly among infants aged 4 to 7 months.

Primary Objective: The central focus is on evaluating the feasibility aspects associated with the RCT design within our clinical setting.

Participants: Infants meeting the inclusion criteria will be recruited and randomized into two distinct groups:

1. Treatment Group: Receiving cranial orthosis therapy initiated one week post their initial physiatrist visit.

2. Control Group: Adhering to the standard of care, with cranial orthosis initiation at 7 weeks post their initial physiatrist visit.

Study Procedures: Participants in both groups will undergo a structured series of assessments and interventions, including:

• Head measurements and 3D-scan evaluations to quantify cranial deformities.

• Helmet adjustments by experienced orthotists based on growth and changes in head shape.

• Regular medical follow-ups, totaling four visits during the course of the study.

Post-Treatment Assessments: Upon completion of the cranial orthosis therapy, participants will be required to fill out post-treatment questionnaires, providing valuable insights into their experiences, satisfaction levels, and any potential concerns ;

Related Conditions & MeSH terms

• Plagiocephaly
• Plagiocephaly, Nonsynostotic
• Plagiocephaly, Positional

• NCT number: NCT06173102
• Study type: Interventional
• Source: St. Justine's Hospital
• Contact: Camille Costa, MD
• Phone: 514 345-4607
• Email: camille.costa.med@ssss.gouv.qc.ca
• Status: Recruiting
• Phase: N/A
• Start date: December 7, 2023
• Completion date: October 1, 2024