NCT04020354

Changes Induced by Early HABIT-ILE in Pre-school Children With Uni- and Bilateral Cerebral Palsy

Functional, Neuroplastic and Biomechanical Changes Induced by Early Hand and Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) in Pre-school Children With Uni- and Bilateral Cerebral Palsy

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Université Catholique de Louvain · Academic / Other
• Sex: All
• Age: 12 Months – 59 Months
• Healthy volunteers: Not accepted

Summary

Studying in two randomized controlled trials (RCT) the changes induced by early HABIT-ILE in functional, neuroplastic and biomechanical assessment in children with unilateral and bilateral CP.

Detailed description

This study aims to evaluate the effect of two weeks of early Hand-arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) on bimanual performance in pre-school children with unilateral cerebral palsy (CP) and on gross motor function in those with bilateral CP, compared with two weeks of usual motor activity including usual rehabilitation (control group). We will assess further changes in unilateral performance tests, daily life activities questionnaires and executive function tests. Neuroplastic changes will be assessed using brain imaging (magnetic resonance imaging, MRI) and biomechanical changes will be assessed by using optoelectronic motion capture system with electromyography (EMG), to determine the effect of HABIT-ILE on movement pattern and quality.

Conditions

• Cerebral Palsy

Interventions

Type	Name	Description
BEHAVIORAL	HABIT-ILE	Early Hand and arm bimanual intensive therapy including lower extremities
BEHAVIORAL	Usual Care	Usual customary care

Timeline

• Start date: 2018-11-27
• Primary completion: 2021-12-31
• Completion: 2022-06-30
• First posted: 2019-07-16
• Last updated: 2022-05-25

Locations

3 sites across 3 countries: Belgium, France, Italy