About this trial
PILKE study uses wearables for assessing motor development in infants in order to define functional growth trajectories in the normal infants and infants at risk of neurological compromise. In addition, PILKE studies correlation of early motor development to later neurocognitive development.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
age at enrollment 5-8mos
typically developing
Disqualifiers
all neurologically significant medical histories during pregnancy, at birth or postnatally
suspicion of developmental delay
suspicion or diagnosis of syndromes with neuromotor symptoms
Trial population
Infants at 5-8mos of age. Upper age limit may be extended until the infant learns to stand up. Groups have either no medical history (#1) or a suspicion or risk of neurodevelopmental delay/deviance (#2)
Trial design
Cohort
Prospective
Treatments tested in this trial
physiotherapy
Other interventionSome infants will receive physiotherapy as a part of their clinically indicated care.
brace
DeviceSome infants in the hip dysplasia group will receive brace and/or cast as a part of their clinically indicated care
Treatment groups
Trial outcomes
Primary outcomes
neurocognitive development
The total score of the neuropsychological examination Bayley scales III will be used
neurological development
Binary information (normal vs abnormal) is taken from the postnatal follow-up clinic inspection that is done according to the national standards (www.thl.fi)
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Helsinki University Central Hospital
Lead sponsor
University of Helsinki
Collaborator
Aalto University
Collaborator
Tampere University
Collaborator