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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05527080
Study type Observational
Source Helsinki University Central Hospital
Contact Sampsa Vanhatalo, prof
Phone 00358505286119
Email sampsa.vanhatalo@helsinki.fi
Status Recruiting
Phase
Start date October 1, 2021
Completion date December 30, 2026

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