Clinical trial Recruiting at 1 site Observational Ages 5 Months to 26 Months

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 typeObservational
Ages5 Months to 26 Months
SexAll
Enrollment250 (estimated)
SponsorHelsinki University Central Hospital
Academic / other
Locations1 site (Helsinki)
StatusRecruiting
StartedOctober 1, 2021
Main results expectedDecember 30, 2026
Study endsDecember 30, 2027
Registry record updatedApril 3, 2025
Trial IDNCT05527080 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.