An interventional study of Cranial Orthosis in Plagiocephaly, Plagiocephaly, Nonsynostotic and Plagiocephaly, Positional, sponsored by St. Justine's Hospital. Completed at 1 site in Canada. Open to participants aged 122 Days to 212 Days. Per ClinicalTrials.gov, last updated 2025-01-16.
Sponsored by St. Justine's Hospital · Not applicable, Interventional, and Other
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:
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.
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:
Study Procedures: Participants in both groups will undergo a structured series of assessments and interventions, including:
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
Exclusion Criteria:
Early cranial orthosis (reception 1 week after initial visit)
Device: Cranial Orthosis
Usual cranial orthosis (reception 7 weeks after initial visit)
Device: Cranial Orthosis
Early versus usual reception of orthosis.
Qualitative information on Feasibility
documenting difficulties encountered during the pilot study, including but not limited to loss at follow-up, missed appointments, missing questionnaires, difficulties with enrollment, and coordination of appointments between the PM\&R service and the Orthotics clinic.
Time frame: through study completion, average of 12 weeks per patient
Cranial Vault Asymmetry (CVA)
The difference between the longest and shortest cranial diagonals, measured in millimeters.
Time frame: at week 0, week 6 and week 12
Cranial Vault Asymmetry Index (CVAI)
A percentage value that considers the overall size of the head in relation to CVA.
Time frame: at week 0, week 6 and week 12
Parental Satisfaction:
Measured with a parental questionnaire at the end of treatment, assessing satisfaction with head shape and cranial orthosis therapy.
Time frame: through completion of study, on average 12 weeks per patient
Adverse Effects:
Any adverse effects observed during cranial orthosis therapy will be collected from parental questionnaires and medical chart records.
Time frame: through completion of study, on average 12 weeks per patient
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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St. Justine's Hospital