Actively Recruiting
Effects of Early Crawling Training Via a Mini-Skateboard on the Motor Development of Very Premature Infants at Risk For Neurodevelopmental Disorder
Led by Marianne Barbu-Roth · Updated on 2023-09-13
50
Participants Needed
3
Research Sites
208 weeks
Total Duration
On this page
Sponsors
M
Marianne Barbu-Roth
Lead Sponsor
E
Ecole Pratique des Hautes Etudes
Collaborating Sponsor
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Born between 24 and 26 weeks gestational age or between 26 and 32 weeks with suspected brain lesion
- Parental consent provided
- Family lives in the intervention area
- Infant tolerates the first Crawliskate trial
You will not qualify if you...
- Bronchodysplasia defined by oxygen dependency after 36 weeks gestational age
- Presence of medical disease
- Limb deformity
- Karyotype anomaly
- Visual or auditory impairment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 8 weeks
Participants in the Crawli Group receive 8 weeks of daily crawling stimulation training at home using a mini-skateboard, with sessions guided by a trained therapist or parents trained by the therapist. Control group participants receive usual care.
Daily sessions at home with therapist or parent guidance
Duration - Up to 5 years corrected age
Participants undergo motor development assessments and neurological evaluations at multiple time points up to 5 years corrected age to monitor progress.
Assessments at 39-42 weeks gestational age, 2, 6, 9, 12, 18, 24, 28 months, and 5 years corrected age
Trial Site Locations
Total: 3 locations
1
Hôpital Paris Saint-Joseph
Paris, France, 75014
Actively Recruiting
2
Cnrs Umr 8002
Paris, Île-de-France Region, France, 75006
Actively Recruiting
3
Hôpital Robert Debré
Paris, Île-de-France Region, France, 75019
Actively Recruiting
Research Team
M
Marianne Barbu-Roth, PhD
E
Elodie Hinnekens, PT, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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