|- candidate number||1741|
|- NTR Number||NTR440|
|- Date ISRCTN created||27-jan-2006|
|- date ISRCTN requested||18-nov-2005|
|- Date Registered NTR||2-okt-2005|
|- Secondary IDs||N/A |
|- Public Title||Asymmetry in Infancy
The effect of pediatric physical therapy on the course of positional preference, deformational plagiocephaly and subsequent developmental delay.|
|- 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.|
|- 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.|
|- Healt Condition(s) or Problem(s) studied||No condition, healthy person|
|- 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 dysmorfisms 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 postional torticollis.
|- Exclusion criteria||1. Positional preference caused by pathology, for example congenital congenital muscular torticollis, structural scoliosis, osseal disorders, cerebral palsy;|
4. Synostotic plagiocephaly (craniosynostosis).
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||22-jan-2005|
|- planned closingdate||1-okt-2007|
|- Target number of participants||385|
|- Interventions||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.
|- Primary outcome||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 every of 4 investigation moments: T0 to T3.
T0 = 6-8 weeks
T1 = 6 months
T2 = 12 months
T3 = 24 months.
|- Secondary outcome||Answers to the questionairs to investigate the experiences of parents of all participating children.|
|- Trial web site||http://www.kinderfysiotherapiewkz.nl|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||PT. PCS. BSc. L.A. Vlimmeren, van|
|- CONTACT for SCIENTIFIC QUERIES||PT. PCS. MSc. PhD. P.J.M. Helders|
|- Sponsor/Initiator ||Bernhoven Hospital, Veghel|
(Source(s) of Monetary or Material Support)
|Stichting Nuts Ohra|
|- Publications||1. Van Vlimmeren LA, Helders PJ, Van Adrichem LN, et al. Diagnostic strategies for the evaluation of asymmetry in infancy; A Review. Eur J Pediatr. 2004;163:185-191.|
2. Van Vlimmeren LA, Helders PJ, Van Adrichem LN, Engelbert RHH. Torticollis and plagiocephaly in infancy: Therapeutic strategies - A Review. Ped Rehab 2005. In press.
3. Van Vlimmeren LA, Takken T, Van Adrichem LNA, Van der Graaf Y, Helders PJM, Engelbert RHH. Plagiocephalometry: a non-invasive method to quantify asymmetry of the skull - a reliability study -
Eur J Pediatr 2005. In press.
|- Brief summary||This trial started with a cohort study of 400 newborns. At the age of 6-8 weeks the state of asymmetry of infancy is achieved by several parameters. The randomised controlled trial include four groups of children. |
Because I am not working in an Academic Centre and my long holiday, I heard the ultimate date to announce this trail very late. I hope it will be possible to register this trial, which was started before july 2005.
|- Main changes (audit trail)|
|- RECORD||2-okt-2005 - 5-jan-2010|