Development of Motility and Cognition in Infants (PILKE)

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.

Study Overview

• Status: Recruiting
• Conditions: Neurodevelopmental Disorders; Child Development; Developmental Delay; Development, Infant; Neurophysiologic Abnormality; Cognitive Developmental Delay
• Intervention / Treatment: Other: physiotherapy; Device: brace

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 Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

• Study Contact: Name: Sampsa Vanhatalo, prof; Phone Number: 00358505286119; Email: sampsa.vanhatalo@helsinki.fi
• Study Contact Backup: Name: Leena Haataja, prof; Phone Number: 00358504272069; Email: leena.haataja@hus.fi

Study Locations

• Finland
  • Helsinki, Finland
    • Recruiting
    • BABA, Clinical Trial Unit, New Children's Hospital
    • Contact: Sampsa Vanhatalo, prof
    • Contact: Leena Haataja, prof

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 months to 2 years (Child)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Infants at 5-8mos of age. Upper age limit may be extended until the infant learns to stand up.

Groups have either no medical history (#1) or a suspicion or risk of neurodevelopmental delay/deviance (#2)

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
typically developing infants; recruitment at 5-8mos of age; infants are considered typically developing if they are born at term age with no neurologically significant medical history, and they are not medically followed up for a suspicion of such. The benchmark for this is taken from the nationally harmonized pre/postnatal screening practise.
neurodevelopmental concern; 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.	Other: physiotherapy; Some infants will receive physiotherapy as a part of their clinically indicated care.
hip dysplasia concern; 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)	Device: brace; Some infants in the hip dysplasia group will receive brace and/or cast as a part of their clinically indicated care; Other Names: cast

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
neurocognitive development	The total score of the neuropsychological examination Bayley scales III will be used	24 months
neurological development	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)	12 months

Collaborators and Investigators

• Sponsor: Helsinki University Central Hospital
• Collaborators: University of Helsinki; Tampere University; Aalto University
• Investigators: Principal Investigator: Sampsa K Vanhatalo, prof, University of Helsinki

Publications and helpful links

General Publications

• Airaksinen M, Gallen A, Kivi A, Vijayakrishnan P, Hayrinen T, Ilen E, Rasanen O, Haataja LM, Vanhatalo S. Intelligent wearable allows out-of-the-lab tracking of developing motor abilities in infants. Commun Med (Lond). 2022 Jun 15;2:69. doi: 10.1038/s43856-022-00131-6. eCollection 2022.
• Yamada T, Nakamura K, Horie K, Yamashita Y, Iwaku M. [Extent of odontoblast process in normal and carious dentin]. Kokubyo Gakkai Zasshi. 1982 Jun;49(2):325-32. No abstract available. Japanese.

Helpful Links

• Official study website at the host lab pages

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2027

Study Registration Dates

• First Submitted: August 23, 2022
• First Submitted That Met QC Criteria: September 1, 2022
• First Posted (Actual): September 2, 2022

Study Record Updates

• Last Update Posted (Actual): April 3, 2025
• Last Update Submitted That Met QC Criteria: March 30, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: wearable; neurodevelopment; growth chart; medical wearable; human activity recognition
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders
• Other Study ID Numbers: PILKE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No