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

April 11, 2022 updated by: Otto Bock France SNC

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

452

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Annecy, France
        • Chabloz Orthopédie Annecy
      • Castelnau-le-Lez, France
        • Orthèse Prothèse Changeant OPC
      • Cournon-d'Auvergne, France
        • Chabloz Orthopédie Clermont-Ferrand
      • Lay-Saint-Christophe, France
        • Technic'Ortho
      • Nice, France
        • Chabloz Orthopédie Nice
      • Oullins, France
        • Chabloz Orthopédie Lyon
      • Paris, France
        • Orthèses Prothèses Générales OPG
      • Portes-lès-Valence, France
        • Chabloz Orthopédie Valence
      • Saint-Apollinaire, France
        • Chabloz Orthopédie Dijon
      • Seyssinet-Pariset, France
        • Chabloz Orthopédie Grenoble
      • Toulouse, France
        • Chabloz Orthopédie Toulouse
      • Venelles, France
        • Chabloz Orthopédie Venelles

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 months to 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The study population is composed of infants who have been fitted with an Ottobock helmet to treat their positional cranial deformation: plagiocephaly, brachycephaly or a combination of these two deformations.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Ottobock helmet
Infants treated with an Ottobock helmet
Device: Ottobock helmet
Patients treated in current practice
Other Names:
  • MyCRO Band

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cranial deformation index
Time Frame: 6 weeks
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
Time Frame: Through study completion, an average of 6 months
QUEST 2.0
Through study completion, an average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Otto Bock France SNC

Collaborators

Quanta Medical

Investigators

  • Study Chair: Hannelore Willenborg, Dr., Hannover University Hospital Center, Diakovere Annastift, Germany
  • Study Chair: Dorothea Daentzer, Prof.Dr.med., Hannover University Hospital Center, Diakovere Annastift, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2021

Primary Completion (Actual)

January 15, 2022

Study Completion (Actual)

January 31, 2022

Study Registration Dates

First Submitted

November 15, 2021

First Submitted That Met QC Criteria

November 30, 2021

First Posted (Actual)

December 10, 2021

Study Record Updates

Last Update Posted (Actual)

April 12, 2022

Last Update Submitted That Met QC Criteria

April 11, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BP-11-PT006-FR-01-2108

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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