Neurodevelopmental DisordersPILKENCT05527080
Development of Motility and Cognition in Infants
An observational study of Neurodevelopmental Disorders and Developmental Delay, run by Helsinki University Central Hospital at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 26 monthsHealthy volunteers can take part
- Conditions the study is for
- Neurodevelopmental Disorders, Developmental Delay, Development, Infant
- What is being tested?
- physiotherapy and brace
- Type of treatment
- Medical device
- How many people
- 250 participants
- Where
- 1 siteFinland
- Study dates
- 1 Oct 2021to 30 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 26 months
- All sexes
- Healthy volunteers accepted
- Child
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)
Who may be able to join
- age at enrollment 5-8mos
- typically developing
Who cannot join
- all neurologically significant medical histories during pregnancy, at birth or postnatally
- suspicion of developmental delay
- suspicion or diagnosis of syndromes with neuromotor symptoms
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Finland1 site, 1 recruiting
- Recruiting
BABA, Clinical Trial Unit, New Children's Hospital
Helsinki
Sampsa Vanhatalo, prof
Leena Haataja, prof
About this study
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.
Read the 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.
- Conditions
- Neurodevelopmental Disorders, Developmental Delay, Development, Infant, Child Development, Cognitive Developmental Delay, Neurophysiologic Abnormality
- Being tested
- physiotherapy, brace
- Keywords
- wearable, medical wearable, human activity recognition, growth chart, neurodevelopment
- Medical subject headings
- Neurodevelopmental Disorders, Learning Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physiotherapyOther
Some infants will receive physiotherapy as a part of their clinically indicated care.
braceDevice
Also called cast
Some infants in the hip dysplasia group will receive brace and/or cast as a part of their clinically indicated care
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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) Receives: Device: brace |
What is being measured
The primary outcome is the main question the study is designed to answer.
neurocognitive development
The total score of the neuropsychological examination Bayley scales III will be used
Measured: 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)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2022
- Study start1 Oct 2021
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Neurodevelopmental DisordersStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Helsinki, Aalto University, Tampere University
- Responsible party
- Principal investigator, Sampsa Vanhatalo, Helsinki University Central Hospital
- Investigators
- Sampsa K Vanhatalo, prof, Principal investigator, University of Helsinki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05527080
- Sponsor's protocol ID
- PILKE
- Acronym
- PILKE
- Status last verified
- Mar 2025
- First submitted
- 23 Aug 2022
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 35721830Airaksinen 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.
PubMed 31932616
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Motility and Cognition in Infants
- ClinicalTrials.gov ID
- NCT05527080
- Acronym / sponsor ID
- PILKE / PILKE
- Conditions
- Neurodevelopmental Disorders, Developmental Delay, Development, Infant, Child Development, Cognitive Developmental Delay, Neurophysiologic Abnormality
- Keywords
- wearable, medical wearable, human activity recognition, growth chart, neurodevelopment
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Collaborators
- University of Helsinki, Aalto University, Tampere University
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 2 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Other: physiotherapyrecruitment 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 | – | Device: bracerecruitment 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) |
Who may qualify
- Ages
- 5 to 26 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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)
Key inclusion criteria (2 listed)
- age at enrollment 5-8mos
- typically developing
Key exclusion criteria (3 listed)
- all neurologically significant medical histories during pregnancy, at birth or postnatally
- suspicion of developmental delay
- suspicion or diagnosis of syndromes with neuromotor symptoms
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| physiotherapySome infants will receive physiotherapy as a part of their clinically indicated care. | Other | neurodevelopmental concern |
| braceAlso: castSome infants in the hip dysplasia group will receive brace and/or cast as a part of their clinically indicated care | Device | hip dysplasia concern |
Primary outcome
neurocognitive development
Time frame: 24 months
The total score of the neuropsychological examination Bayley scales III will be used
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Background: PubMed 35721830Airaksinen 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.
- Results publication: PubMed 31932616Airaksinen 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.
- Official study website at the host lab pagesLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sampsa K Vanhatalo, prof principal investigator
University of Helsinki
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurodevelopmental Disorders and Developmental Delay, run by Helsinki University Central Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sampsa Vanhatalo, prof (00358505286119, sampsa.vanhatalo@helsinki.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
neurocognitive development (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05527080, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.