NCT04698395

HABIT-ILE in Infants and Toddlers With Cerebral Palsy (Baby HABIT-ILE)

Effects of HABIT-ILE in Secondary Brain Damage Outcomes of Infants and Toddlers With Signs of Cerebral Palsy

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Université Catholique de Louvain · Academic / Other
• Sex: All
• Age: 8 Months – 18 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Cerebral Palsy

Interventions

Type	Name	Description
BEHAVIORAL	Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE)	motor learning-based, intensive therapy for children with cerebral palsy
BEHAVIORAL	Regular care	customary or usual care given to any infant/toddler with cerebral palsy

Timeline

• Start date: 2021-02-15
• Primary completion: 2022-08-01
• Completion: 2023-12-01
• First posted: 2021-01-06
• Last updated: 2021-10-01

Locations

1 site across 1 country: Belgium