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

Completed

• Conditions: Plagiocephaly, Positional; Brachycephaly; Plagiocephaly, Nonsynostotic
• Interventions: Device: Ottobock helmet

• Registration Number: NCT05154175
• Lead Sponsor: Otto Bock France SNC

Brief Summary

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

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).

Study Timeline

• Study Start: 2021-11-15
• Study First Submitted: 2021-11-15
• Study First Submitted QC: 2021-11-30
• Study First Posted: 2021-12-10
• Primary Completion: 2022-01-15
• Study Completion: 2022-01-31
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-11
• Last Update Posted: 2022-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 452

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ottobock helmet	Ottobock helmet	Infants treated with an Ottobock helmet

Primary Outcome Measures

Name	Time	Method
Cranial deformation index	6 weeks	The cranial deformation index is a ratio (%) of head diameters characterizing head deformation.

Secondary Outcome Measures

Name	Time	Method
Satisfaction of parents regarding the device and the services provided by the orthotist	Through study completion, an average of 6 months	QUEST 2.0

Trial Locations

Locations (12)

Technic'Ortho; 🇫🇷 Lay-Saint-Christophe, France

Chabloz Orthopédie Nice; 🇫🇷 Nice, France

Chabloz Orthopédie Annecy; 🇫🇷 Annecy, France

Orthèse Prothèse Changeant OPC; 🇫🇷 Castelnau-le-Lez, France

Chabloz Orthopédie Clermont-Ferrand; 🇫🇷 Cournon-d'Auvergne, France

Chabloz Orthopédie Toulouse; 🇫🇷 Toulouse, France

Chabloz Orthopédie Lyon; 🇫🇷 Oullins, France

Chabloz Orthopédie Venelles; 🇫🇷 Venelles, France

Orthèses Prothèses Générales OPG; 🇫🇷 Paris, France

Chabloz Orthopédie Valence; 🇫🇷 Portes-lès-Valence, France

Chabloz Orthopédie Grenoble; 🇫🇷 Seyssinet-Pariset, France

Chabloz Orthopédie Dijon; 🇫🇷 Saint-Apollinaire, France