Trials / Recruiting
RecruitingNCT05527080
Development of Motility and Cognition in Infants
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 250 (estimated)
- Sponsor
- Helsinki University Central Hospital · Academic / Other
- Sex
- All
- Age
- 5 Months – 26 Months
- Healthy volunteers
- Accepted
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.
Conditions
- Neurodevelopmental Disorders
- Developmental Delay
- Development, Infant
- Child Development
- Cognitive Developmental Delay
- Neurophysiologic Abnormality
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | physiotherapy | Some infants will receive physiotherapy as a part of their clinically indicated care. |
| DEVICE | brace | Some infants in the hip dysplasia group will receive brace and/or cast as a part of their clinically indicated care |
Timeline
- Start date
- 2021-10-01
- Primary completion
- 2026-12-30
- Completion
- 2027-12-30
- First posted
- 2022-09-02
- Last updated
- 2025-04-03
Locations
1 site across 1 country: Finland
Source: ClinicalTrials.gov record NCT05527080. Inclusion in this directory is not an endorsement.