Actively Recruiting
Study of Early Crawling Training Using a Mini-Skateboard to Help Motor Development in Very Premature Infants at Risk for Developmental Delays
Led by Marianne Barbu-Roth · Updated on 2023-09-13
50
Participants Needed
3
Research Sites
208 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are investigating whether early crawling training using a mini-skateboard called the Crawliskate can help very premature infants at high risk for developmental delays improve their motor and neuropsychological development. The study focuses on infants born between 24 and 26 weeks of gestation or between 26 and 32 weeks with major brain lesions, aiming to determine if this early intervention accelerates their motor skills and overall development compared to usual care. This approach builds on prior findings that crawling on a mini-skateboard stimulates motor and locomotor development effectively in typical newborns. The study randomly assigns infants to one of two groups. The Crawli group receives daily crawling training at home for eight weeks after hospital discharge, using the Crawliskate under the supervision of physiotherapists and parents trained by therapists. Each session lasts about 10 minutes, where infants lie prone on the mini-skateboard and perform limb movements to move forward with adult assistance. The Control group receives standard medical care without additional crawling training. Participants are assessed on crawling proficiency at term-equivalent age and at two and six months corrected age. Their motor skills are evaluated between two and twelve months corrected age using 2D and 3D movement recordings. Neurodevelopmental progress is tracked from birth to 28 months corrected age using several tools, including the Bayley Scale of Infant and Toddler Development BSID III, Amiel-Tison Neurological Assessment, Prechtl Assessment, and Age and Stage Questionnaires ASQ-3. An additional ASQ-3 is given at five years. The primary outcome is the gross motor score on the BSID III at 12 months corrected age, with safety and development monitored throughout the study lasting until 2029.
CONDITIONS
Brief Title
Early Intervention Based on Neonatal Crawling in Very Premature Infants at Risk For Neurodevelopmental Disorder
Research Team
M
Marianne Barbu-Roth, PhD
E
Elodie Hinnekens, PT, PhD
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here