NCT06173102

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

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: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: St. Justine's Hospital · Academic / Other
• Sex: All
• Age: 122 Days – 212 Days
• Healthy volunteers: Not accepted

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.

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 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

Conditions

• Plagiocephaly
• Plagiocephaly, Nonsynostotic
• Plagiocephaly, Positional

Interventions

Type	Name	Description
DEVICE	Cranial Orthosis	Early versus usual reception of orthosis.

Timeline

• Start date: 2023-12-07
• Primary completion: 2024-09-09
• Completion: 2024-09-09
• First posted: 2023-12-15
• Last updated: 2025-01-16

Locations

1 site across 1 country: Canada