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| Name | Class |
|---|---|
| University of Helsinki | OTHER |
| Aalto University | OTHER |
| Tampere University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| physiotherapy | Other | Some infants will receive physiotherapy as a part of their clinically indicated care. |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sampsa Vanhatalo, prof | Contact | 00358505286119 | sampsa.vanhatalo@helsinki.fi | |
| Leena Haataja, prof | Contact | 00358504272069 | leena.haataja@hus.fi |
| Name | Affiliation | Role |
|---|---|---|
| Sampsa K Vanhatalo, prof | University of Helsinki | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BABA, Clinical Trial Unit, New Children's Hospital | Recruiting | Helsinki | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35721830 | 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. | |
| 31932616 | Result | 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. |
| Label | URL |
|---|---|
| Official study website at the host lab pages | View source |
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| ID | Term |
|---|---|
| D065886 | Neurodevelopmental Disorders |
| D007859 | Learning Disabilities |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D003147 | Communication Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D026741 | Physical Therapy Modalities |
| D001915 | Braces |
| D002370 | Casts, Surgical |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
| D009989 | Orthotic Devices |
| D009983 | Orthopedic Equipment |
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| brace | Device | Some infants in the hip dysplasia group will receive brace and/or cast as a part of their clinically indicated care |
|
|
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013523 |
| Surgical Equipment |
| D004864 | Equipment and Supplies |
| D016267 | External Fixators |
| D009984 | Orthopedic Fixation Devices |
| D053831 | Surgical Fixation Devices |