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ISRCTN
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ISRCTN84132771
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ClinicalTrials.gov identifier
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Public title
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Asymmetry in infancy - the effect of pediatric physical therapy on the course of positional preference, deformational plagiocephaly and subsequent developmental delay
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Scientific title
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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
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Acronym
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N/A
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Serial number at source
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NTR440
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Study hypothesis
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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.
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Ethics approval
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Ethics approval received from the local ethics committee
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Study design
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Randomised, single blinded, active controlled, parallel group trial
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Countries of recruitment
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Netherlands
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Disease/condition/study domain
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No condition, healthy person
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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)
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Anticipated start date
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22/01/2005
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Anticipated end date
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01/10/2007
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Status of trial
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Completed
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Patient information material
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Target number of participants
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385
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Interventions
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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
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Primary outcome measure(s)
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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
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Secondary outcome measure(s)
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Answers to the questionnaires to investigate the experiences of parents of all participating children
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Sources of funding
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The Nuts-Ohra Foundation (Stichting Nuts Ohra [SNO]) (The Netherlands)
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Trial website
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Publications
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Results in http://www.ncbi.nlm.nih.gov/pubmed/18678802
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Contact name
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Dr
L.A.
van Vlimmeren
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Address
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Bernhoven Hospital Veghel
Department of Physical Therapy
P.O. Box 10.000
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City/town
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Veghel
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Zip/Postcode
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5460 DA
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Country
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Netherlands
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Tel
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+31 (0)413 381935
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Email
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l.vanvlimmeren@bernhoven.nl
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Sponsor
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Bernhoven Hospital Veghel (The Netherlands)
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Address
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P.O. Box 10.000
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City/town
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Veghel
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Zip/Postcode
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5460 DA
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Country
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Netherlands
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Date applied
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27/01/2006
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Last edited
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06/08/2008
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Date ISRCTN assigned
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27/01/2006
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