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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
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.
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.
Age
1 - 4 years
Sex
ALL
Healthy Volunteers
No
Institute of Neuroscience, Université catholique de Louvain
Brussels, Belgium
Fondation ILDYS - Site de Ty Yann
Brest, France
IRCCS Fondazione Stella Maris
Tirrenia, Tuscany, Italy
Start Date
November 27, 2018
Primary Completion Date
December 31, 2021
Completion Date
June 30, 2022
Last Updated
May 25, 2022
100
ESTIMATED participants
HABIT-ILE
BEHAVIORAL
Usual Care
BEHAVIORAL
Lead Sponsor
Université Catholique de Louvain
Collaborators
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT07428928