Child Development, Cognitive Developmental Delay, Developmental Delay, Development, Infant, Neurodevelopmental Disorders, Neurophysiologic Abnormality
Conditions
Keywords
wearable, medical wearable, human activity recognition, growth chart, neurodevelopment
Brief summary
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.
Detailed description
PILKE study builds on the recent development of an infant wearable, MAIJU, a multisensor garment that can be used to quantify infants posture and movement patterns out-of-hospital. The study will recruit typically developing infants (control group) and infants with an identified or suspected risk of neurodevelopmental compromise, as well as infants undergoing orthopedic follow-up for hip issues. Infants will be examined and treated according to clinical routine practise, while MAIJU and other novel measures are added to monitor aspects of neurodevelopment. Recordings with MAIJU will be done every 6-8 weeks from about 5 months to 18 months of age, and the neuropsychological outcome is assessed using Bayley scales at two years of age. The study is observational by design, and the trajectories of motor performance are compared to other clinically identified measures of development.
Interventions
OTHERphysiotherapy
Some infants will receive physiotherapy as a part of their clinically indicated care.
DEVICEbrace
Some infants in the hip dysplasia group will receive brace and/or cast as a part of their clinically indicated care
Sponsors
University of Helsinki
Aalto University
Tampere University
Helsinki University Central Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
5 Months to 26 Months
Healthy volunteers
Yes
Inclusion criteria
* age at enrollment 5-8mos * typically developing
Exclusion criteria
* all neurologically significant medical histories during pregnancy, at birth or postnatally * suspicion of developmental delay * suspicion or diagnosis of syndromes with neuromotor symptoms
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| neurocognitive development | 24 months | The total score of the neuropsychological examination Bayley scales III will be used |
| neurological development | 12 months | 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) |
Countries
Finland
Contacts
Primary ContactSampsa Vanhatalo, prof
Backup ContactLeena Haataja, prof
Outcome results
None listed