Assessing motor and cognitive development in infants using wearables
Development of Motility and Cognition in Infants
Helsinki University Central Hospital · NCT05527080
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 |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 5 Months to 26 Months |
| Sex | All |
| Sponsor | Helsinki University Central Hospital (other) |
| Locations | 1 site (Helsinki) |
| Trial ID | NCT05527080 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are infants aged 5-8 months who are typically developing.
Not a fit: Infants with significant neurological medical histories or those suspected of developmental delays may not benefit from this study.
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 performed: Other studies using wearable technology for monitoring infant development have shown promise, indicating that this approach may yield valuable insights.
Eligibility criteria
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 this trial is running
Helsinki
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Neurodevelopmental Disorders, Developmental Delay, Development, Infant, Child Development, Cognitive Developmental Delay, Neurophysiologic Abnormality, wearable, medical wearable