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NCT Number: NCT05527080

Development of Motility and Cognition in Infants

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.

Recruiting

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Key information

Age range

5 month–26 month

Sex eligibility

All sexes

Study type

Observational

Primary location

BABA, Clinical Trial Unit, New Children's Hospital

Helsinki, Finland

Location status: Recruiting

Location contact

Leena Haataja, prof

CONTACT

Sampsa Vanhatalo, prof

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physiotherapy

Other

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

Brace

Device

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

Other names: cast

Primary outcomes

  1. neurocognitive development

    Time frame: 24 months

    The total score of the neuropsychological examination Bayley scales III will be used

  2. neurological development

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Leena Haataja, prof

CONTACT

[email protected]

00358504272069

Sampsa Vanhatalo, prof

CONTACT

[email protected]

00358505286119

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Collaborators

  • Aalto University
  • Tampere University
  • University of Helsinki

Registry information

Acronym: PILKE

Important dates

Study start
2021
Primary completion
2026
Study completion
2027
First posted
Sep 2, 2022
Registry last updated
Apr 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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