Condition category
Musculoskeletal Diseases
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Dr Magda M. Boere-Boonekamp


Contact details

University of Twente
Health Technology and Services Research
Drienerlolaan 5
P.O.Box 217
7500 AE
+31 (0)53 4894483

Additional identifiers

EudraCT number number

Protocol/serial number

ZonMw nr 170992501

Study information

Scientific title


Study hypothesis

In comparison with a wait-and-see regimen, redression helmet treatment in infants with deformational plagiocephaly (DP) is more effective, measured subjectively with a Satisfaction Outcome Score and objectively with plagiocephalometry.

An ancilliary study is also taking place with the following objective: what is the agreement between parental stated preferences for management of plagiocephaly (measured with conjoint analysis) and actual management preferences (helmet treatment, randomisation, wait and see)?

Thw hypothesis for this ancilliary study is that parental stated preferences predict parental actual decision making.

As of 31/01/2012, the anticipated end date of trial was updated from 31/12/2011 to 30/04/2013.

Ethics approval

Added 11/03/2009: Medical Ethics Committee gave approval on the 8th January 2009 (ref: NL24352.044.08)

Study design

Randomised controlled trial, nested in a follow-up study

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Deformational plagiocephaly/brachycephaly


Included children will be randomly assigned to either helmet treatment or a wait-and-see regimen, both for a period of 6 months.

Intervention group:
Helmet treatment initiated at the age of 5 months and supervised by a physician in one of the two specialised centres. A custom-made helmet is constructed by an orthotist and is made of mouldable plastic. The helmet is worn both day and night, for an average of four to six months.

Wait-and-see group:
Recovery of the deformation of the head is awaited by allowing spontaneous growth of the skull. Preceding physiotherapy will be discontinued.

The paediatric physiotherapist will perform the follow-up measurements in both the intervention and the wait-and-see group at the age of 8, 12, and 24 months (and 48 months, beyond the scope of this study). During these measuring moments, advice is given on positioning and handling of the child. This advice is also given by YHC physicians and nurses as part of usual care to all infants.

Intervention type



Not Specified

Drug names

Primary outcome measure

(A)symmetry of the skull at 8, 12, and 24 months, measured by plagiocephalometry (PCM).

Secondary outcome measures

Main study:
1. Subjective outcome score (at 5, 12, 24 months)
2. (Psycho)motor development (at 5, 12 and 24 months)
3. Quality of life (at 2 years)
4. Parental attitudes (at 5, 12 and 24 months)
5. Parental anxiety level and parental concerns (at 5, 12 and 24 months)
6. Satisfaction with the treatment (at 12 and 24 months)

Secondary outcome of the ancillary methods study:
1. Decisional conflict scale
2. Actual preference for treatment (helmet, wait-and-see, randomised controlled trial [RCT])
3. Stated preference for treatment

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Children 5 months of age, either sex
2. Moderate to severe DP:
2.1. Plagiocephaly: 108% less than or equal to Oblique Diameter Difference Index (ODDI) less than or equal to 113%
2.2. Brachycephaly: 95% less than or equal to Cranial Proportional Index (CPI) less than or equal to 104%
2.3. Mixed forms according to adjusted criteria

Participant type


Age group




Target number of participants


Participant exclusion criteria

1. Premature children
2. Children with congenital muscular torticollis
3. Synostosis
4. Dysmorphisms
5. Neurological dysfunctions

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

University of Twente
7500 AE

Sponsor information


The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)

Sponsor details

Laan van Nieuw Oost Indië 334
P.O.Box 93245
The Hague
2509 AE

Sponsor type

Research organisation



Funder type

Research organisation

Funder name

The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands) (ref: 80-82310-98-09091)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

2012 protocol in:
2014 results in:

Publication citations

  1. Protocol

    van Wijk RM, Boere-Boonekamp MM, Groothuis-Oudshoorn CG, van Vlimmeren LA, IJzerman MJ, HElmet therapy Assessment in infants with Deformed Skulls (HEADS): protocol for a randomised controlled trial., Trials, 2012, 13, 108, doi: 10.1186/1745-6215-13-108.

  2. Results

    van Wijk RM, van Vlimmeren LA, Groothuis-Oudshoorn CG, Van der Ploeg CP, Ijzerman MJ, Boere-Boonekamp MM, Helmet therapy in infants with positional skull deformation: randomised controlled trial., BMJ, 2014, 348, g2741.

Additional files

Editorial Notes