Status:
COMPLETED
Cranial Orthosis Therapy for Plagiocephaly: an RCT Pilot Study Comparing Cranial Orthosis to the Natural Course
Lead Sponsor:
St. Justine's Hospital
Conditions:
Plagiocephaly
Plagiocephaly, Nonsynostotic
Eligibility:
All Genders
122-212 years
Phase:
NA
Brief 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 ...
Detailed 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 plagioc...
Eligibility Criteria
Inclusion
- All participants must be assessed by a physiatrist at Sainte-Justine Hospital at the plagiocephaly clinic of the physical medicine and rehabilitation service.
- 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.
- Participants must be aged from 4 months and 0 days to 7 months old minus a day at the onset of cranial orthosis therapy. Premature subjects will be age-adjusted by calculating the post-partum age minus the number of weeks of prematurity, rounding to the whole nearest month.
- Participants' parents (or legal guardian) must be apt to give consent and able to reliably express themselves (either written or verbally, if illiterate or unable to write for any other reason).
Exclusion
- Patients whose 3D-scan measurements do not confirm a severe plagiocephaly.
- Participants who are lost at follow-up or who drop out of treatment will be excluded.
- Participants whose parents report less than 20 hours per day on average of helmet wear.
- Participants with synostotic cranial deformation.
- Patients with isolated brachycephaly, without a plagiocephalic component to the deformation.
- Patients with other craniofacial deformities or syndromes.
- Patients having had their orthosis made or modified at a laboratory other than the Sainte-Justine hospital/Centre de réadaptation Marie-Enfant.
Key Trial Info
Start Date :
December 7 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 9 2024
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06173102
Start Date
December 7 2023
End Date
September 9 2024
Last Update
January 16 2025
Active Locations (1)
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1
Sainte-Justine Hospital
Montreal, Quebec, Canada, H3T 1C5