HABIT-ILE in Infants and Toddlers With Cerebral Palsy (Baby HABIT-ILE)
NCT ID: NCT04698395
Last Updated: 2021-10-01
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
48 participants
INTERVENTIONAL
2021-02-15
2023-12-31
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
Baby HABIT-ILE (Hand-Arm Bimanual Intensive Therapy Including Lower Extremities) intervention during two weeks
Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE)
motor learning-based, intensive therapy for children with cerebral palsy
Regular care
Usual customary care intervention during two weeks
Regular care
customary or usual care given to any infant/toddler with cerebral palsy
Interventions
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Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE)
motor learning-based, intensive therapy for children with cerebral palsy
Regular care
customary or usual care given to any infant/toddler with cerebral palsy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* age 8 to 18 months 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 6 months after the intervention time.
* severe visual impairments
* severe cognitive impairments
* contraindications to perform magnetic image resonance (MRI) assessments (metal implants, etc.)
8 Months
18 Months
ALL
No
Sponsors
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University Hospital of Mont-Godinne
OTHER
Université Catholique de Louvain
OTHER
Responsible Party
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Principal Investigators
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Yannick Bleyenheuft, PhD
Role: PRINCIPAL_INVESTIGATOR
MSL-IN Lab, Institute of Neuroscience, UCLouvain
Yves Vandermeeren, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Institute of Neuroscience, UCLouvain; CHU-UCL Namur, Neurology Department, UCLouvain
Locations
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Institute of Neuroscience, Université catholique de Louvain
Brussels, , Belgium
Countries
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Central Contacts
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Facility Contacts
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References
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Carton de Tournai A, Herman E, Ebner-Karestinos D, Gathy E, Araneda R, Renders A, De Clerck C, Kilcioglu S, Dricot L, Macq B, Vandermeeren Y, Bleyenheuft Y. Hand-Arm Bimanual Intensive Therapy Including Lower Extremities in Infants With Unilateral Cerebral Palsy: A Randomized Clinical Trial. JAMA Netw Open. 2024 Nov 4;7(11):e2445133. doi: 10.1001/jamanetworkopen.2024.45133.
Carton de Tournai A, Herman E, Gathy E, Ebner-Karestinos D, Araneda R, Dricot L, Macq B, Vandermeeren Y, Bleyenheuft Y. Baby HABIT-ILE intervention: study protocol of a randomised controlled trial in infants aged 6-18 months with unilateral cerebral palsy. BMJ Open. 2024 Feb 17;14(2):e078383. doi: 10.1136/bmjopen-2023-078383.
Other Identifiers
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B403201316810g
Identifier Type: -
Identifier Source: org_study_id
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