Assessing motor and cognitive development in infants using wearables
Official title: Development of Motility and Cognition in Infants
Run by Helsinki University Central Hospital · NCT05527080 · Data updated 2026-11-12
This study is testing a special wearable garment to see how it can help track the motor and cognitive development of infants, both those developing normally and those at risk for developmental issues.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 5 Months to 26 Months |
| Sex | All |
| Enrollment | 250 (estimated) |
| Sponsor | Helsinki University Central Hospital Academic / other |
| Locations | 1 site (Helsinki) |
| Status | Recruiting |
| Started | October 1, 2021 |
| Main results expected | December 30, 2026 |
| Study ends | December 30, 2027 |
| Registry record updated | April 3, 2025 |
| Trial ID | NCT05527080 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are infants aged 5-8 months who are typically developing.
✕Probably not a fit
Infants with significant neurological medical histories or those suspected of developmental delays may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The PILKE study utilizes a multisensor wearable garment called MAIJU to monitor motor development in infants, aiming to establish functional growth trajectories for both typically developing infants and those at risk of neurodevelopmental disorders. The study involves regular assessments every 6-8 weeks from 5 to 18 months of age, with neuropsychological outcomes evaluated using Bayley scales at two years. By comparing motor performance trajectories with clinically identified developmental measures, the study seeks to understand the correlation between early motor skills and later cognitive development.
Why it matters
Potential benefit: If successful, this study could provide insights into early interventions for infants at risk of neurodevelopmental issues, potentially improving long-term cognitive outcomes.
How similar studies have gone: Other studies using wearable technology for monitoring infant development have shown promise, indicating that this approach may yield valuable insights.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
BABA, Clinical Trial Unit, New Children's Hospital
Helsinki, Finland Recruiting
Study contacts
- Principal investigator: Sampsa K Vanhatalo, prof — University of Helsinki
- Study coordinator: Sampsa Vanhatalo, prof
- Email: sampsa.vanhatalo@helsinki.fi
- Phone: 00358505286119
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.