No registrations found.
ID
Source
Brief title
Health condition
The children are born at the Bernhoven Hospital at Veghel, The Netherlands. The effects of the patients and controls are evaluated at the outpatient Department of the Bernhoven Hospital at veghel, The Netherlands
Sponsors and support
P.O.Box 10.000
5460 DA Veghel
The Netherlands
Telephone: +31-413-381911
P.O. Box 229
1000 AE Amsterdam
Intervention
Outcome measures
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.
Background 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.
Study objective
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.
Study design
N/A
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.
P.O. Box 10.000
L.A. Vlimmeren, van
Veghel 5460 DA
The Netherlands
+31 (0)413 381935
l.vanvlimmeren@bernhoven.nl
P.O. Box 10.000
L.A. Vlimmeren, van
Veghel 5460 DA
The Netherlands
+31 (0)413 381935
l.vanvlimmeren@bernhoven.nl
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;
2. Dysmorfism;
3. Syndroms;
4. Synostotic plagiocephaly (craniosynostosis).
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL400 |
| NTR-old | NTR440 |
| Other | : N/A |
| ISRCTN | ISRCTN84132771 |
Summary results
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. <br>
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.