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
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
-
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.