Development of Motility and Cognition in Infants

NCT05527080 | Recruiting

• 1 other identifier: PILKE
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurodevelopmental Disorders; Developmental Delay; Development, Infant; Child Development; Cognitive Developmental Delay; Neurophysiologic Abnormality

Keywords

wearable; medical wearable; human activity recognition; growth chart; neurodevelopment

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

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

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

Interventions

physiotherapy OTHER

Some infants will receive physiotherapy as a part of their clinically indicated care.

neurodevelopmental concern

brace DEVICE

Some infants in the hip dysplasia group will receive brace and/or cast as a part of their clinically indicated care

Also known as: cast

hip dysplasia concern

Eligibility Criteria

• Age: 5 Months - 26 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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)

You may qualify if:

• age at enrollment 5-8mos
• typically developing

You may not qualify if:

• all neurologically significant medical histories during pregnancy, at birth or postnatally
• suspicion of developmental delay
• suspicion or diagnosis of syndromes with neuromotor symptoms

Sponsors & Collaborators

• Helsinki University Central Hospital: lead
• University of Helsinki: collaborator
• Aalto University: collaborator
• Tampere University: collaborator

Study Sites (1)

BABA, Clinical Trial Unit, New Children's Hospital

Helsinki, Finland

RECRUITING

Related Publications (2)

• 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.

  PMID: 6957504 BACKGROUND

• 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.

  PMID: 35721830 BACKGROUND

Related Links

• Official study website at the host lab pages

MeSH Terms

Conditions

Neurodevelopmental Disorders; Learning Disabilities

Interventions

Physical Therapy Modalities; Braces; Casts, Surgical

Condition Hierarchy (Ancestors)

Mental Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation; Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; External Fixators; Orthopedic Fixation Devices; Surgical Fixation Devices

Study Officials

• Sampsa K Vanhatalo, prof

  University of Helsinki

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sampsa Vanhatalo, prof

CONTACT

00358505286119; sampsa.vanhatalo@helsinki.fi

Leena Haataja, prof

CONTACT

00358504272069; leena.haataja@hus.fi

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor in clinical neurophysiology

Study Record Dates

• First Submitted: August 23, 2022
• First Posted: September 2, 2022
• Study Start: October 1, 2021
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2027
• Last Updated: April 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)