Status:
COMPLETED
The Small Step Program - Early Intervention for Children With High Risk of Developing Cerebral Palsy
Lead Sponsor:
St. Olavs Hospital
Collaborating Sponsors:
Norwegian University of Science and Technology
Conditions:
Cerebral Palsy
Eligibility:
All Genders
3-8 years
Phase:
NA
Brief Summary
Children with cerebral palsy (CP) have life-long motor disorders caused by brain injuries which occur around birth. These children go through extensive treatment during childhood, but the treatment ha...
Detailed Description
The efficacy of the Small Step program is presently being investigated through a randomized controlled trial (NCT02166801) at Karolinska Institutet (KI) in Stockholm, Sweden. In the original project p...
Eligibility Criteria
Inclusion
- increased perinatal risk factors, such as preterm birth, hypoxic ischemic encephalopathy (asphyxia), and morphological brain abnormalities. These "at-risk" children are included in the regular clinical follow-up program at St. Olavs University Hospital comprising a standard examination at 3 months of age (for preterm born children: 3 months post term, so-called corrected age). At this examination, infants who exhibit two or more of the following additional risk factors will be eligible for study participation:
- Neurological signs assessed with Hammersmith Infant Neurological Examination (HINE) with a cut-off score of \< 57 (20).
- Delayed psycho-motor development measured with Alberta Infant Motor Scale (AIMS) using 2SD as the cut-off.
- Absent or sporadic fidgety movements assessed with the General Movements Assessment (GMA)
- Pathological findings on cerebral imaging (magnetic resonance imaging-MRI/cerebral ultrasound) done in regular clinical practice.
Exclusion
- unstable medical condition
- progressive disorders
- diagnosis with a specific syndrome.
- neither parent is fluent in Norwegian or English. Satisfactory skills in either language are required for participation in data collection and the coaching and education program.
Key Trial Info
Start Date :
September 7 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 7 2021
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03264339
Start Date
September 7 2017
End Date
June 7 2021
Last Update
September 9 2021
Active Locations (1)
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1
St Olavs Hospital
Trondheim, Norway