Condition category
Not Applicable
Date applied
27/01/2006
Date assigned
27/01/2006
Last edited
06/08/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr L.A. van Vlimmeren

ORCID ID

Contact details

Bernhoven Hospital Veghel
Department of Physical Therapy
P.O. Box 10.000
Veghel
5460 DA
Netherlands
+31 (0)413 381935
l.vanvlimmeren@bernhoven.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR440

Study information

Scientific title

Asymmetry in infancy - a prospective, randomised trial: the effect of pediatric physical therapy on the course of postional preference, deformational plagiocephaly and subsequent developmental delay, in children of 6 weeks to 24 months of age, measured with plagiocephalometry, range of motion tests and motor assessment

Acronym

Study hypothesis

Pediatric physical therapy is effective in asymmetry in infancy, especially to positional preference, deformational plagiocephaly and natural course of asymmetrical motor development, established by plagiocephalometry, range of motion tests and motor assessment.

Ethics approval

Ethics approval received from the local ethics committee

Study design

Randomised, single blinded, active controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

No condition, healthy person

Intervention

Study population:
Group 1: Positional preference (+/- deformational plagiocephaly) with pediatric physical therapy
Group 2: Positional preference (+/- deformational plagiocephaly) without pediatric physical therapy
Group 3: Deformational plagiocephaly without positional preference
Group 4: No positional preference and/or deformational plagiocephaly

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Parameters:
1. Shape of the head established by the features and values of plagiocephalometry
2. Active and passive range of motion measurements of the cervical column
3. Motor development by the Alberta Infant Motor Scale and the Bailey Scales of Infant Development second edition

All outcome parameters will be established at 4 investigation moments: T0 to T3
T0 = 6-8 weeks
T1 = 6 months
T2 = 12 months
T3 = 24 months

Secondary outcome measures

Answers to the questionnaires to investigate the experiences of parents of all participating children

Overall trial start date

22/01/2005

Overall trial end date

01/10/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Healthy infants of 6 to 8 weeks of age, born at or after a gestational age of 36 weeks or more, without dysmorphisms or syndromatic symptoms
2. With or without positional preference of the head and with or without deformational plagiocephaly
3. Positional preference and deformational plagiocephaly are based on positional torticollis

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

385

Participant exclusion criteria

1. Positional preference caused by pathology, for example congenital muscular torticollis, structural scoliosis, osseal disorders, cerebral palsy
2. Dysmorphism
3. Syndromes
4. Synostotic plagiocephaly (craniosynostosis)

Recruitment start date

22/01/2005

Recruitment end date

01/10/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

Bernhoven Hospital Veghel
Veghel
5460 DA
Netherlands

Sponsor information

Organisation

Bernhoven Hospital Veghel (The Netherlands)

Sponsor details

P.O. Box 10.000
Veghel
5460 DA
Netherlands

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Research organisation

Funder name

The Nuts-Ohra Foundation (Stichting Nuts Ohra [SNO]) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Results - basic reporting

Publication summary

Results in http://www.ncbi.nlm.nih.gov/pubmed/18678802

Publication citations

  1. Results

    van Vlimmeren LA, van der Graaf Y, Boere-Boonekamp MM, L'Hoir MP, Helders PJ, Engelbert RH, Effect of pediatric physical therapy on deformational plagiocephaly in children with positional preference: a randomized controlled trial., Arch Pediatr Adolesc Med, 2008, 162, 8, 712-718, doi: 10.1001/archpedi.162.8.712.

Additional files

Editorial Notes