Effectiveness of Ottobock Helmet Therapy in Infants With Plagiocephaly, Brachycephaly or Combination of Both

Study Overview
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Brief Summary
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The objective of the research is to measure the effectiveness of the Ottobock helmet, an innovative 3D-printed cranial orthosis used to correct infant cranial positional deformation: plagiocephaly, brachycephaly or combination of both. This research is a retrospective multi-centric study composed of a collection of clinical data from orthotists database and a survey for patient's parents.

Detailed Description
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The Ottobock helmet is a cranial orthosis used to correct infant cranial positional deformation: plagiocephaly, brachycephaly or combination of both. This medical device is a 3D-printed helmet, with an elastic closing system which allow the head growth, maintain a constant pressure in the helmet and ensure a good adjustment. Even though there is an effectiveness observed, there are no existing clinical evidences on this type of helmet so far, and there is a need to conduct a research on a large number of patients to measure the effectiveness and describe the population treated. This study will give more information to health professionals (doctors, orthopedic technicians, etc.) and health authorities, about the benefits of the orthopedic treatment of the positional cranial deformations in infants. The study is composed of an electronic case report form (eCRF) to be fulfilled by the orthotists and an electronic questionnaire (ePRO) to be fulfilled by the patient's parents. The electronic questionnaires, data treatment and analysis are handled by a Contract Research Organization (CRO).

Official Title
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Effectiveness of Ottobock Helmet Therapy in Infants With Plagiocephaly, Brachycephaly or Combination of Both and Parents' Satisfaction

Conditions
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Plagiocephaly, Positional, Plagiocephaly, Nonsynostotic, Brachycephaly

Intervention / Treatment
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* Device: Ottobock helmet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infant with positional cranial deformation Infant treated with an Ottobock helmet between May 1st, 2020 and May 1st, 2021 Exclusion Criteria: Patient whose parents (or legal guardians) disagree to participate in the study. Patient whose parents (or legal guardians) are unable to understand or answer the questionnaire.

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ottobock helmet<br>Infants treated with an Ottobock helmet | Device: Ottobock helmet<br>* Patients treated in current practice<br>* Other names: MyCRO Band;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cranial deformation index | The cranial deformation index is a ratio (%) of head diameters characterizing head deformation. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction of parents regarding the device and the services provided by the orthotist | QUEST 2.0 | Through study completion, an average of 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cranial orthosis, Helmet treatment