CompletedNot Applicable

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

France452 participantsStarted 2021-11-15

Plain-language 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.

Who can participate

Age range3 Months – 2 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Cranial deformation index

Timeframe: 6 weeks

Trial details

NCT IDNCT05154175

SponsorOtto Bock France SNC

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2022-01-15

View on ClinicalTrials.gov More Plagiocephaly, Positional trials