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

NCT06173102 | Completed

• 1 other identifier: 2024-5800
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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 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

Outcome Measures

Primary Outcomes (1)

• 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.

  through study completion, average of 12 weeks per patient

Secondary Outcomes (4)

• Cranial Vault Asymmetry (CVA)

  at week 0, week 6 and week 12

• Cranial Vault Asymmetry Index (CVAI)

  at week 0, week 6 and week 12

• Parental Satisfaction:

  through completion of study, on average 12 weeks per patient

• Adverse Effects:

  through completion of study, on average 12 weeks per patient

Study Arms (2)

Early Cranial Orthosis

EXPERIMENTAL

Early cranial orthosis (reception 1 week after initial visit)

Device: Cranial Orthosis

Usual Cranial Orthosis

OTHER

Usual cranial orthosis (reception 7 weeks after initial visit)

Device: Cranial Orthosis

Interventions

Cranial Orthosis DEVICE

Early versus usual reception of orthosis.

Early Cranial Orthosis; Usual Cranial Orthosis

Eligibility Criteria

• Age: 122 Days - 212 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Justine's Hospital: lead

Study Sites (1)

Sainte-Justine Hospital

Montreal, Quebec, H3T 1C5, Canada

Location

MeSH Terms

Conditions

Plagiocephaly; Plagiocephaly, Nonsynostotic

Condition Hierarchy (Ancestors)

Craniofacial Abnormalities; Musculoskeletal Abnormalities; Musculoskeletal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Camille Costa, MD

  Université de Montréal, CHU Sainte-Justine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Researcher

Model Details: randomization sequence will be created using Microsoft Excel 2022 with a 1:1 allocation using random block sizes of 2 and

Study Record Dates

• First Submitted: November 30, 2023
• First Posted: December 15, 2023
• Study Start: December 7, 2023
• Primary Completion: September 9, 2024
• Study Completion: September 9, 2024
• Last Updated: January 16, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)