Development of Motility and Cognition in Infants

Recruiting

• Conditions: Cognitive Developmental Delay; Neurophysiologic Abnormality; Child Development; Neurodevelopmental Disorders; Developmental Delay; Development, Infant
• Interventions: Other: physiotherapy; Device: brace

• Registration Number: NCT05527080
• Lead Sponsor: Helsinki University Central Hospital

Brief 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.

Study Timeline

• Study Start: 2021-10-01
• Study First Submitted: 2022-08-23
• Study First Submitted QC: 2022-09-01
• Study First Posted: 2022-09-02
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-30
• Last Update Posted: 2025-04-03
• Primary Completion: 2026-12-30
• Study Completion: 2027-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
neurodevelopmental concern	physiotherapy	recruitment at 5-8mos of age; infants are recruited from the outpatient clinic in the New Children's hospital (NCH). They have either a known perinatal risk factor (e.g.stroke, HIE, meningitis), or they are referred to pediatric neurologists at NCH due to a suspected delay or deviance in neurodevelopment.
hip dysplasia concern	brace	recruitment at 2-6 weeks of age after perinatal clinical suspicion of hip dysplacia. These infants may be left out of follow-up (mild), or treated by orthopedic clinic with a soft brace (moderate) or a stronger cast (sever)

Primary Outcome Measures

Name	Time	Method
neurological development	12 months	Binary information (normal vs abnormal) is taken from the postnatal follow-up clinic inspection that is done according to the national standards (www.thl.fi)
neurocognitive development	24 months	The total score of the neuropsychological examination Bayley scales III will be used

Trial Locations

Locations (1)

BABA, Clinical Trial Unit, New Children's Hospital; 🇫🇮 Helsinki, Finland