Asymmetry in infancy - the effect of pediatric physical therapy on the course of positional preference, deformational plagiocephaly and subsequent developmental delay

ISRCTN	ISRCTN84132771
DOI	https://doi.org/10.1186/ISRCTN84132771
Protocol serial number	NTR440
Sponsor	Bernhoven Hospital Veghel (The Netherlands)
Funder	The Nuts-Ohra Foundation (Stichting Nuts Ohra [SNO]) (The Netherlands)

Submission date: 27/01/2006
Registration date: 27/01/2006
Last edited: 06/08/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr L.A. van Vlimmeren
Scientific

Bernhoven Hospital Veghel
Department of Physical Therapy
P.O. Box 10.000
Veghel
5460 DA
Netherlands

Phone	+31 (0)413 381935
Email	l.vanvlimmeren@bernhoven.nl

Study information

Primary study design	Interventional
Study design	Randomised, single blinded, active controlled, parallel group trial
Secondary study design	Randomised controlled trial
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
Study objectives	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(s)	Ethics approval received from the local ethics committee
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	Answers to the questionnaires to investigate the experiences of parents of all participating children
Completion date	01/10/2007

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	6 Weeks
Upper age limit	8 Weeks
Sex	All
Target sample size at registration	385
Key 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
Key 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)
Date of first enrolment	22/01/2005
Date of final enrolment	01/10/2007

Locations

Countries of recruitment

Netherlands

Study participating centre

Bernhoven Hospital Veghel

Veghel
5460 DA
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	01/08/2008		Yes	No