Status:
UNKNOWN
Changes Induced by Early HABIT-ILE in Pre-school Children With Uni- and Bilateral Cerebral Palsy
Lead Sponsor:
Université Catholique de Louvain
Collaborating Sponsors:
University Hospital, Brest
University of Pisa
Conditions:
Cerebral Palsy
Eligibility:
All Genders
12-59 years
Phase:
NA
Brief 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 ...
Eligibility Criteria
Inclusion
- children with unilateral or bilateral cerebral palsy (spastic or dyskinetic)
- age 1 to 4 years inclusive (corrected age if preterm birth)
- ability to follow instructions and complete testing according to the age.
Exclusion
- active seizure
- programmed botulinum toxin or orthopedic surgery in the 6 months previous to the intervention, during intervention period or 3months after the intervention time
- severe visual impairments
- severe cognitive impairments
- contraindications to perform MRI assessments (Metal implants, etc.)
Key Trial Info
Start Date :
November 27 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2022
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04020354
Start Date
November 27 2018
End Date
June 30 2022
Last Update
May 25 2022
Active Locations (3)
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1
Institute of Neuroscience, Université catholique de Louvain
Brussels, Belgium, 1200
2
Fondation ILDYS - Site de Ty Yann
Brest, France
3
IRCCS Fondazione Stella Maris
Tirrenia, Tuscany, Italy, 56128