Cerebral Palsy Clinical Trial
— BAMBIOfficial title:
Neuro-biomechanical Aspects Determining the Motor Behavior in Infants With High-risk of Neuromotor Impairments
This project focuses on motor development, muscle growth and muscle activity. Using advanced, instrumented tests such as , the link between muscles and the movement characteristics will be studied. In addition, the evolution of these neuro-biomechanical determinants during the first year of life will be investigated. The examinations are planned for a group of high-risk infants (e.g. premature birth, cases of asphyxia, etc.) compared with a group of infants with typical development.
Status | Recruiting |
Enrollment | 348 |
Est. completion date | December 31, 2027 |
Est. primary completion date | March 31, 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 35 Weeks to 1 Year |
Eligibility | Inclusion & exclusion criteria for group of high-risk infants: - Infants born before or at 28 weeks of gestation - Infants born after 28 weeks of gestation and with brain injury. - A term birth with the clinical diagnosis of asphyxia (ischemic event with hypothermia) or neonatal stroke - Exclusion in case of genetic syndrome, or lower limb pathology (e.g. spina bifida) Inclusion & exclusion criteria for group of typically developing children: - Born at a gestational age above 37 weeks - Birth weight between P10 and P90 - Head circumference between P10 and P90 - Ph >7.1 - Exclusion in case of genetic syndrome, lower limb pathology and/or brain malformations |
Country | Name | City | State |
---|---|---|---|
Switzerland | University Hospitals Geneva | Geneva |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Geneva |
Switzerland,
De Beukelaer N, Vandekerckhove I, Huyghe E, Molenberghs G, Peeters N, Hanssen B, Ortibus E, Van Campenhout A, Desloovere K. Morphological Medial Gastrocnemius Muscle Growth in Ambulant Children with Spastic Cerebral Palsy: A Prospective Longitudinal Study. J Clin Med. 2023 Feb 16;12(4):1564. doi: 10.3390/jcm12041564. — View Citation
Gough M, Shortland AP. Could muscle deformity in children with spastic cerebral palsy be related to an impairment of muscle growth and altered adaptation? Dev Med Child Neurol. 2012 Jun;54(6):495-9. doi: 10.1111/j.1469-8749.2012.04229.x. Epub 2012 Feb 27. — View Citation
Pascal A, Govaert P, Oostra A, Naulaers G, Ortibus E, Van den Broeck C. Neurodevelopmental outcome in very preterm and very-low-birthweight infants born over the past decade: a meta-analytic review. Dev Med Child Neurol. 2018 Apr;60(4):342-355. doi: 10.1111/dmcn.13675. Epub 2018 Jan 19. — View Citation
Rosenbaum P, Paneth N, Leviton A, Goldstein M, Bax M, Damiano D, Dan B, Jacobsson B. A report: the definition and classification of cerebral palsy April 2006. Dev Med Child Neurol Suppl. 2007 Feb;109:8-14. Erratum In: Dev Med Child Neurol. 2007 Jun;49(6):480. — View Citation
Willerslev-Olsen M, Choe Lund M, Lorentzen J, Barber L, Kofoed-Hansen M, Nielsen JB. Impaired muscle growth precedes development of increased stiffness of the triceps surae musculotendinous unit in children with cerebral palsy. Dev Med Child Neurol. 2018 Jul;60(7):672-679. doi: 10.1111/dmcn.13729. Epub 2018 Mar 24. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | General Movement Assessment | Observation of general movements following the Prechtl's General Movement Assessment, interpreted by observing age-specific general movement components and extracting the Motor Optimality Score (0-12, the higher, the better outcome) | 35-36 weeks of gestation; term equivalent age, 3 months (corrected) age | |
Primary | Hammersmith Neonatal/Infant Neurological Examination | Neurological assessment for different domains such as muscle tone, postures, movements and reflexes . Resulting in total scores (0-78) which can be compared to norm values, and higher scores indicate better outcome. | 35-36 weeks of gestation; term equivalent age, 3 months (corrected) age, 6 months (corrected) age and 12 months (corrected) age. | |
Primary | Change in muscle morphology size | The size of the lower leg muscles defined by freehand ultrasound | 35-36 weeks of gestation; term equivalent age, 3 months (corrected) age, 6 months (corrected) age and 12 months (corrected) age. | |
Primary | Change in muscle morphology length | The length of the lower leg muscles defined by freehand ultrasound | 35-36 weeks of gestation; term equivalent age, 3 months (corrected) age, 6 months (corrected) age and 12 months (corrected) age. | |
Primary | Change in muscle activity | Investigation of the muscle activity during spontaneous, whole body movements by using surface electromyography. | 35-36 weeks of gestation; term equivalent age, 3 months (corrected) age, 6 months (corrected) age and 12 months (corrected) age. | |
Primary | Change in motor behaviour | Investigation movement quality/quantify during spontaneous, whole body movements by using reflective markers. | 35-36 weeks of gestation; term equivalent age, 3 months (corrected) age, 6 months (corrected) age and 12 months (corrected) age. | |
Secondary | Bayley Scales of Infant and Toddler Development - Version III | Standardized neurodevelopmental test of gross and fine motor skills. Higher scores indicate better outcome. | 3 months (corrected) age, 6 months (corrected) age and 12 months (corrected) age. | |
Secondary | Alberta Infant Motor Scale (AIMS) | Assessment of gross motor development during prone, supine, sitting and standing. Scores from 0-60. Higher scores indicate better outcome. | 3 months (corrected) age, 6 months (corrected) age and 12 months (corrected) age. | |
Secondary | Magnetic resonance imaging of the brain: classification | Qualitatively assessment on the MRI classification system by Himmelman et al. to classify the nature of brain abnormalities. | up to 4 weeks post-term age | |
Secondary | Magnetic resonance imaging of the brain: quantification | Qualitatively assessment on the MRI classification system by quantitative assessment using the Kidokoro scoring system to classify the extent of white and grey matter abnormalities. Total global scores were classified as normal (0-3), mild (4-7), moderate (8-11), or severe (=12) brain abnormalities. | up to 4 weeks post-term age |
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