Development of Motility and Cognition in Infants
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: physiotherapy, brace.
- Who it may be relevant to
- Registry conditions: Neurodevelopmental Disorders, Developmental Delay, Development, Infant, Child Development. Basic parameters: 5 months — 26 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Finland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- 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
Primary outcome measures
- neurocognitive development [Time frame: 24 months]
- neurological development [Time frame: 12 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Finland · 1 center
- BABA, Clinical Trial Unit, New Children's Hospital — Helsinki
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. PMID 35721830
- Airaksinen M, Rasanen O, Ilen E, Hayrinen T, Kivi A, Marchi V, Gallen A, Blom S, Varhe A, Kaartinen N, Haataja L, Vanhatalo S. Automatic Posture and Movement Tracking of Infants with Wearable Movement Sensors. Sci Rep. 2020 Jan 13;10(1):169. doi: 10.1038/s41598-019-56862-5. PMID 31932616
Identifiers
NCT: NCT05527080 · PILKE