Changes Induced by Early HABIT-ILE in Pre-school Children With Uni- and Bilateral Cerebral Palsy
NCT ID: NCT04020354
Last Updated: 2022-05-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2018-11-27
2022-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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HABIT-ILE
Early HABIT-ILE (Hand and arm bimanual intensive therapy including lower extremities) will be applied over 2 weeks.
HABIT-ILE
Early Hand and arm bimanual intensive therapy including lower extremities
Usual Care
A two weeks period of usual customary care
Usual Care
Usual customary care
Interventions
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HABIT-ILE
Early Hand and arm bimanual intensive therapy including lower extremities
Usual Care
Usual customary care
Eligibility Criteria
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Inclusion Criteria
* age 1 to 4 years inclusive (corrected age if preterm birth)
* ability to follow instructions and complete testing according to the age.
Exclusion Criteria
* 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.)
12 Months
59 Months
ALL
No
Sponsors
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University Hospital, Brest
OTHER
University of Pisa
OTHER
University Hospital, Angers
OTHER_GOV
University of Lausanne Hospitals
OTHER
University of the Balearic Islands
OTHER
Fondation Paralysie Cérébrale
OTHER
Université Catholique de Louvain
OTHER
Responsible Party
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Yannick Bleyenheuft
Professor
Principal Investigators
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Yannick Bleyenheuft, Pr
Role: PRINCIPAL_INVESTIGATOR
MSL-IN Lab, Institute of Neuroscience, Université catholique de Louvain
Locations
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Institute of Neuroscience, Université catholique de Louvain
Brussels, , Belgium
Fondation ILDYS - Site de Ty Yann
Brest, , France
IRCCS Fondazione Stella Maris
Tirrenia, Tuscany, Italy
Countries
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References
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Araneda R, Ebner-Karestinos D, Paradis J, Klocker A, Saussez G, Demas J, Bailly R, Bouvier S, Carton de Tournai A, Herman E, Souki A, Le Gal G, Nowak E, Sizonenko SV, Newman CJ, Dinomais M, Riquelme I, Guzzetta A, Brochard S, Bleyenheuft Y. Changes Induced by Early Hand-Arm Bimanual Intensive Therapy Including Lower Extremities in Young Children With Unilateral Cerebral Palsy: A Randomized Clinical Trial. JAMA Pediatr. 2024 Jan 1;178(1):19-28. doi: 10.1001/jamapediatrics.2023.4809.
Araneda R, Sizonenko SV, Newman CJ, Dinomais M, Le Gal G, Nowak E, Guzzetta A, Riquelme I, Brochard S, Bleyenheuft Y; Early HABIT-ILE group. Functional, neuroplastic and biomechanical changes induced by early Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (e-HABIT-ILE) in pre-school children with unilateral cerebral palsy: study protocol of a randomized control trial. BMC Neurol. 2020 Apr 14;20(1):133. doi: 10.1186/s12883-020-01705-4.
Other Identifiers
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B403201316810d
Identifier Type: -
Identifier Source: org_study_id
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