At a glance
ClinicalIndex Comparison RecordN/ACompleted· 452 enrolled
Drug / intervention
Ottobock helmetdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Effectiveness of Ottobock Helmet Therapy in Infants With Plagiocephaly, Brachycephaly or Combination of Both and Parents' Satisfaction
In Brief
An observational study evaluating Ottobock helmet for Plagiocephaly, Positional and 2 related conditions. Completed, enrolled 452 participants across 12 sites.
Detailed 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.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesFrance
CollaboratorsQuanta Medical
Timeline
N/ACompletedFinished
20222023202420252026
Enrollment StartNov 2021
First PostedDec 2021
Primary CompletionJan 2022
Study CompletionJan 2022
TodayJul 2026
First PostedDec 10, 2021
Enrollment StartNov 15, 2021
Primary CompletionJan 15, 2022
Study CompletionJan 31, 2022
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 4.6 years ago
Interventions
Ottobock helmetdevice
Patients treated in current practice