Effectiveness of Ottobock Helmet Therapy in Infants With Plagiocephaly, Brachycephaly or Combination of Both
Sponsored by Otto Bock France SNC
About this trial
Last updated 3 years ago
Study ID
BP-11-PT006-FR-01-2108
Status
Completed
Type
Observational
Placebo
No
Accepting
3 to 2 Years
All
Not accepting
Healthy Volunteers
Trial Timing
Ended 3 years ago
What is this trial about?
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.
What are the participation requirements?
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.