Clinical trial NCT04698395: HABIT-ILE in Infants and Toddlers With Cerebral Palsy (Baby HABIT-ILE)
Official title: Effects of HABIT-ILE in Secondary Brain Damage Outcomes of Infants and Toddlers With Signs of Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebral Palsy
Lead sponsor: Université Catholique de Louvain
Sponsor class: OTHER
Collaborators: name: University Hospital of Mont-Godinne
First posted: 2021-01-06
Enrollment: 48
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Allocation
Primary purpose: TREATMENT

Brief summary: Using a randomized controlled trial design, the possible changes induced by the intensive treatment programme "Hand-arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE)" in functional, everyday life activities and neuroplastic assessment will be studied in infants and toddlers with cerebral palsy.

Detailed description: Using a randomized controlled trial design, the possible changes in neuroimaging, motor function and everyday life activities of infants and toddlers at risk of or with a diagnosis of cerebral palsy after participating of the intensive treatment programme "Hand-arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE)" will be studied . Changes, scored by parents in case of questionnaires and by experts in the case of tests, will be observed comparing infants/toddlers after their regular care and after receiving HABIT-ILE. Motor function and daily life activities will be correlated with neuroplastic changes. Moreover, possible therapy onset outcomes differences will be observed.

Eligibility criteria: Inclusion Criteria:

* children with diagnosed unilateral cerebral palsy or at risk of developing unilateral cerebral palsy or with signs of unilateral cerebral palsy
* age 8 to 18 months inclusive (corrected age if preterm birth)
* ability to follow instructions and complete testing according to the age.

Exclusion Criteria:

* active seizure
* programmed botulinum toxin or orthopedic surgery in the 6 months previous to the intervention, during intervention period or 6 months after the intervention time.
* severe visual impairments
* severe cognitive impairments
* contraindications to perform magnetic image resonance (MRI) assessments (metal implants, etc.)

Primary outcomes:
measure: Changes on the Mini-Assisting Hand Assessment (Mini-AHA)
timeFrame: baseline, 3 weeks, 13 weeks and 26 weeks after baseline
Secondary outcomes:
measure: Changes in Bayley Scales of Infant and Toddler Development - Third Edition (BSID-III)
timeFrame: baseline, 3 weeks, 13 weeks and 26 weeks after baseline
measure: Changes in Gross Motor Function Measure - 66 (GMFM-66)
timeFrame: baseline, 3 weeks, 13 weeks and 26 weeks after baseline
measure: Changes in Visuo-spatial attention assessment with the "Batterie d'évaluation du Jeune Enfant" (BAJE)
timeFrame: baseline, 3 weeks, 13 weeks and 26 weeks after baseline
measure: State of visual impairment of peripheral origin assessed with the standard Battery of Ophthalmological test for infants
timeFrame: baseline
measure: Changes in Pediatric Evaluation of Disability Inventory-Computer Adaptive Test (PEDI-CAT)
timeFrame: baseline, 3 weeks, 13 weeks and 26 weeks after baseline
measure: Changes in Young children's participation and environment measure (YC-PEM)
timeFrame: baseline, 3 weeks, 13 weeks and 26 weeks after baseline
measure: Changes in Canadian Occupational Performance Measure (COPM)
timeFrame: baseline, 3 weeks, 13 weeks and 26 weeks after baseline
measure: Changes in straightness on kinematics of the upper extremity
timeFrame: baseline, 3 weeks, 13 weeks and 26 weeks after baseline
measure: Changes in smoothness on kinematics of the upper extremity
timeFrame: baseline, 3 weeks, 13 weeks and 26 weeks after baseline
measure: Changes in time of activity on kinematics of the upper extremity
timeFrame: baseline, 3 weeks, 13 weeks and 26 weeks after baseline
measure: Changes in the quantification of physical activity
timeFrame: baseline, 3 weeks, 13 weeks and 26 weeks after baseline
measure: Changes in cortical thickness of the brain's gray matter
timeFrame: baseline, 3 weeks, 13 weeks and 26 weeks after baseline
measure: Changes in Fractional Anisotropy (FA) of the corticospinal tract from the motor cortex to the cerebellar peduncle
timeFrame: baseline, 3 weeks, 13 weeks and 26 weeks after baseline
measure: Changes on the Axial, Radial and Mean Diffusivity (AD, RD, MD) of the corticospinal tract from the motor cortex to the cerebellar peduncle
timeFrame: baseline, 3 weeks, 13 weeks and 26 weeks after baseline
measure: Changes on the metrics of the corticospinal tract from the motor cortex to the cerebellar peduncle using the NODDI model
timeFrame: baseline, 3 weeks, 13 weeks and 26 weeks after baseline
measure: Changes of the fraction and heterogeneity in the neural fibers or isotropic compartments of the corticospinal tract from the motor cortex to the cerebellar peduncle using the DIAMOND model
timeFrame: baseline, 3 weeks, 13 weeks and 26 weeks after baseline
measure: Changes in resting-state functional connectivity
timeFrame: baseline, 3 weeks, 13 weeks and 26 weeks after baseline
measure: Changes in brain white matter microstructure (WM-μs) using the Microstructure Fingerprinting model
timeFrame: baseline, 3 weeks, 13 weeks and 26 weeks after baseline
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Institute of Neuroscience, Université catholique de Louvain
Study officials:
affiliation: MSL-IN Lab, Institute of Neuroscience, UCLouvain
name: Yannick Bleyenheuft, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute of Neuroscience, UCLouvain; CHU-UCL Namur, Neurology Department, UCLouvain
name: Yves Vandermeeren, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: