Asymmetry in Infancy The effect of pediatric physical therapy on the course of positional preference, deformational plagiocephaly and subsequent developmental delay.

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.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON20651

Enrollment

385

Registered

2005-10-02

Start date

2005-01-22

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Eligibility

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
Answers to the questionairs to investigate the experiences of parents of all participating children.	—

Contacts

Public ContactL.A. Vlimmeren, van

Bernhoven Hospital, Veghel, Department of Physical Therapy, P.O. Box 10.000

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

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)