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Plagiocephaly, PositionalNCT05154175

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

An observational study of Plagiocephaly, Positional and Plagiocephaly, Nonsynostotic, run by Otto Bock France SNC at 12 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 3 months to 2 years
What is being tested?
Ottobock helmet
Type of treatment
Medical device
How many people
452 participants
Where
12 sitesFrance
Study dates
15 Nov 2021to 31 Jan 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 months to 2 years
  • All sexes
  • No healthy volunteers
  • Child

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.

Who may be able to join

  • Infant with positional cranial deformation
  • Infant treated with an Ottobock helmet between May 1st, 2020 and May 1st, 2021

Who cannot join

  • 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.

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

France12 sites

  • Chabloz Orthopédie Annecy

    Annecy

  • Orthèse Prothèse Changeant OPC

    Castelnau-le-Lez

  • Chabloz Orthopédie Clermont-Ferrand

    Cournon-d'Auvergne

  • Technic'Ortho

    Lay-Saint-Christophe

  • Chabloz Orthopédie Nice

    Nice

  • Chabloz Orthopédie Lyon

    Oullins

  • Orthèses Prothèses Générales OPG

    Paris

  • Chabloz Orthopédie Valence

    Portes-lès-Valence

  • Chabloz Orthopédie Dijon

    Saint-Apollinaire

  • Chabloz Orthopédie Grenoble

    Seyssinet-Pariset

  • Chabloz Orthopédie Toulouse

    Toulouse

  • Chabloz Orthopédie Venelles

    Venelles

Other trials in France

About this study

Official title: 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.

Read the 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).

Being tested
Ottobock helmet
Keywords
Cranial orthosis, Helmet treatment
Medical subject headings
Plagiocephaly, Nonsynostotic, Craniosynostoses

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ottobock helmetDevice

    Also called MyCRO Band

    Patients treated in current practice

Study groups in NCT05154175
Study groupRoleWhat they receive
Ottobock helmetInfants treated with an Ottobock helmet
Receives: Device: Ottobock helmet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cranial deformation index

    The cranial deformation index is a ratio (%) of head diameters characterizing head deformation.

    Measured: 6 weeks

Secondary outcomes (1)

  1. Satisfaction of parents regarding the device and the services provided by the orthotist

    QUEST 2.0

    Measured: Through study completion, an average of 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2021
  2. Study start15 Nov 2021
  3. Primary completion15 Jan 2022
  4. Study completion31 Jan 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Retrospective
Enrolment
452 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05154175
Sponsor's protocol ID
BP-11-PT006-FR-01-2108
Status last verified
Apr 2022
First submitted
15 Nov 2021
Last updated
12 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Undecided

Publications

  • Argenta L, David L, Thompson J. Clinical classification of positional plagiocephaly. J Craniofac Surg. 2004 May;15(3):368-72. doi: 10.1097/00001665-200405000-00004.

    PubMed 15111792

  • van Vlimmeren LA, Takken T, van Adrichem LN, van der Graaf Y, Helders PJ, Engelbert RH. Plagiocephalometry: a non-invasive method to quantify asymmetry of the skull; a reliability study. Eur J Pediatr. 2006 Mar;165(3):149-57. doi: 10.1007/s00431-005-0011-1. Epub 2005 Oct 7.

    PubMed 16211401

  • Graham JM Jr, Gomez M, Halberg A, Earl DL, Kreutzman JT, Cui J, Guo X. Management of deformational plagiocephaly: repositioning versus orthotic therapy. J Pediatr. 2005 Feb;146(2):258-62. doi: 10.1016/j.jpeds.2004.10.016.

    PubMed 15689920

  • Moss SD. Nonsurgical, nonorthotic treatment of occipital plagiocephaly: what is the natural history of the misshapen neonatal head? J Neurosurg. 1997 Nov;87(5):667-70. doi: 10.3171/jns.1997.87.5.0667.

    PubMed 9347972

  • Wendling-Keim DS, Mace Y, Lochbihler H, Dietz HG, Lehner M. A new parameter for the management of positional plagiocephaly: the size of the anterior fontanelle matters. Childs Nerv Syst. 2020 Feb;36(2):363-371. doi: 10.1007/s00381-019-04215-y. Epub 2019 Jun 17.

    PubMed 31209640

  • Loveday BP, de Chalain TB. Active counterpositioning or orthotic device to treat positional plagiocephaly? J Craniofac Surg. 2001 Jul;12(4):308-13. doi: 10.1097/00001665-200107000-00003.

    PubMed 11482615

  • Yoo HS, Rah DK, Kim YO. Outcome analysis of cranial molding therapy in nonsynostotic plagiocephaly. Arch Plast Surg. 2012 Jul;39(4):338-44. doi: 10.5999/aps.2012.39.4.338. Epub 2012 Jul 13.

    PubMed 22872837

  • Kim JK, Kwon DR, Park GY. A new ultrasound method for assessment of head shape change in infants with plagiocephaly. Ann Rehabil Med. 2014 Aug;38(4):541-7. doi: 10.5535/arm.2014.38.4.541. Epub 2014 Aug 28.

    PubMed 25229033

  • Holowka MA, Reisner A, Giavedoni B, Lombardo JR, Coulter C. Plagiocephaly Severity Scale to Aid in Clinical Treatment Recommendations. J Craniofac Surg. 2017 May;28(3):717-722. doi: 10.1097/SCS.0000000000003520.

    PubMed 28468155

  • Wilbrand JF, Schmidtberg K, Bierther U, Streckbein P, Pons-Kuehnemann J, Christophis P, Hahn A, Schaaf H, Howaldt HP. Clinical classification of infant nonsynostotic cranial deformity. J Pediatr. 2012 Dec;161(6):1120-5. doi: 10.1016/j.jpeds.2012.05.023. Epub 2012 Jun 23.

    PubMed 22727872

  • Graham JM Jr, Kreutzman J, Earl D, Halberg A, Samayoa C, Guo X. Deformational brachycephaly in supine-sleeping infants. J Pediatr. 2005 Feb;146(2):253-7. doi: 10.1016/j.jpeds.2004.10.017.

    PubMed 15689919

  • Kelly KM, Joganic EF, Beals SP, Riggs JA, McGuire MK, Littlefield TR. Helmet Treatment of Infants With Deformational Brachycephaly. Glob Pediatr Health. 2018 Oct 16;5:2333794X18805618. doi: 10.1177/2333794X18805618. eCollection 2018.

    PubMed 30349871

  • Hinken L, Willenborg H, Davila LA, Daentzer D. Outcome analysis of molding helmet therapy using a classification for differentiation between plagiocephaly, brachycephaly and combination of both. J Craniomaxillofac Surg. 2019 May;47(5):720-725. doi: 10.1016/j.jcms.2019.01.011. Epub 2019 Jan 17.

    PubMed 30733135

  • Schaaf H, Malik CY, Streckbein P, Pons-Kuehnemann J, Howaldt HP, Wilbrand JF. Three-dimensional photographic analysis of outcome after helmet treatment of a nonsynostotic cranial deformity. J Craniofac Surg. 2010 Nov;21(6):1677-82. doi: 10.1097/SCS.0b013e3181f3c630.

    PubMed 21119399

  • Hutchison BL, Hutchison LA, Thompson JM, Mitchell EA. Quantification of plagiocephaly and brachycephaly in infants using a digital photographic technique. Cleft Palate Craniofac J. 2005 Sep;42(5):539-47. doi: 10.1597/04-059r.1.

    PubMed 16149837

Questions about this trial

What is this clinical trial studying?

An observational study of Plagiocephaly, Positional and Plagiocephaly, Nonsynostotic, run by Otto Bock France SNC at 12 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cranial deformation index (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05154175, which also lists 38 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2022.

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