to generate norm data of the IMP and SINDA.
ID
Source
Brief title
Condition
- Congenital and peripartum neurological conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
IMP-scores (total score, and five domainscores (variation, adaptability,
symmetry, fluency, performance)
Secondary outcome
SINDA scores (neuromotor and developmental scores)
Background summary
Recently our institute developed two measurement instruments for the detection
of developmental disorders in infants, the Infant Motor Profile (IMP) and the
Standardized Infant NeuroDevelopmental Assessment (SINDA). Detection of high
risk for developmental disorders at early age is a prerequisite for the
implementation of early intervention at young age when there is maximum
plasticity of the nervous system and chances for improvement are highest.
The IMP is a qualitative assessment of motor behaviour of infants aged 3 to 18
months. In addition to being a tool for the detection of infants at high risk
for developmental disorders, the IMP may be used to monitor changes in motor
development and the effect of early intervention. The SINDA is a tool for
paediatricians to assess infant development at 2 to 12 months. SINDA has a
neuromotor and a developmental scale.
For the implementation of the IMP and SINDA in clinical practise normdata are a
prerequisite.
Study objective
to generate norm data of the IMP and SINDA.
Study design
In order to generate norm data 1700 infants aged 2 to 18 months will be
assessed (100 infants per *month age*). The infants will be recruited via
well-baby clinics and day care centres in the three Northern provinces of the
Netherlands and via the website of the Kinderacademie
(www.dekinderacademie.com). The sample needs to be representative for the Dutch
population in terms of sex, socio-econonmic and ethnic background. The
assessment will consist of an IMP and SINDA assessment and the collection of
demographic characteristics. The data will be used to compute developmental
curves with cut offs for typical, borderline and atypical development.
The infants will be recruited by the Kinderacademie, that has large experience
in the generation of normdata for paediatric tests. The infants will be
assessed by assessors of the Kinderacademie and assessors of the Institute of
Developmental Neurology of the UMCG.
Study burden and risks
The study is not associated with risk for the infant. The assessment of the
infant consists of play activities and the performance of routine neurological
actions such as the pull-to-sit manoeuvre and the assessment of tendon
reflexes. This means that study's burden consists of a time investment of
parents and infant. We consider this investment justified as it ultimately will
result in norm data for two instruments, that currently are implemented in
clinical practise.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
The child lives in one of the three northern provinces of The Netherlands
Age at inclusion between 2 and 18 months
Parents or legal representatives will provide written informed consent
Exclusion criteria
A potential subject who meets any one of the following criteria will be excluded from participation in this study:
Severe illness precluding the assessment, such as complex congenital heart disorders with insufficient oxygen saturation
Parents have insufficient understanding of the Dutch language to be able to give informed consent
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 |
|---|---|
| Other | Aangemeld bij NTR - we wachten nog op een nummer |
| CCMO | NL58069.042.16 |