Evaluation of Functional, Neuroplastic and Biomechanical Changes Induced by an Intensive, Playful Early-morning Treatment Including Lower Limbs (EARLY-HABIT-ILE) in Preschool Children With Uni and Bilateral Cerebral Palsy
NCT ID: NCT04017871
Last Updated: 2021-12-07
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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COMPLETED
NA
42 participants
INTERVENTIONAL
2019-08-18
2021-09-17
Brief Summary
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Hand and Arm Bimanual Intensive Therapy Including Lower Extremities (= HABIT-ILE) applies the concepts of motor skill learning and intensive training to both the Upper Extremities (UE) and Lower Extremities (LE) and has been shown to improve aspects of motor function of the UE and LE in school age children with unilateral and bilateral Cerebral Palsy (CP) across the 3 levels of the International Classification of Functioning, Disability and Health (ICFDH). The principles and content of HABIT-ILE can be applied to pre-school children and this method is highly promising for early rehabilitation.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Interventional
10 days of intensive and structured motor therapy, 5 hours a day = 50h
MRI
MRI at baseline and J90
Electro-Encephalography-High Density (children with unilateral PC only)
Electro-Encephalography-High Density (children with unilateral PC only) at baseline and J90
3D and EMG analysis
3D and EMG analysis at baseline and J90
care and classic activities
physiotherapy and psychomotility. As needed weekly sessions of speech therapist or orthoptist and daily activities of the child.
Accelerometers
During 5 days a sensor at each wrist to quantify their movement.
Control
10 days of care and classic activities
MRI
MRI at baseline and J90
Electro-Encephalography-High Density (children with unilateral PC only)
Electro-Encephalography-High Density (children with unilateral PC only) at baseline and J90
3D and EMG analysis
3D and EMG analysis at baseline and J90
care and classic activities
physiotherapy and psychomotility. As needed weekly sessions of speech therapist or orthoptist and daily activities of the child.
Accelerometers
During 5 days a sensor at each wrist to quantify their movement.
Interventions
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MRI
MRI at baseline and J90
Electro-Encephalography-High Density (children with unilateral PC only)
Electro-Encephalography-High Density (children with unilateral PC only) at baseline and J90
3D and EMG analysis
3D and EMG analysis at baseline and J90
care and classic activities
physiotherapy and psychomotility. As needed weekly sessions of speech therapist or orthoptist and daily activities of the child.
Accelerometers
During 5 days a sensor at each wrist to quantify their movement.
Eligibility Criteria
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Inclusion Criteria
* Aged from 1 to 4 years old (12 to 59 months) (age corrected if prematurity) able to follow instructions and to be able to carry out all the evaluations, according to his age
Exclusion Criteria
* Uncontrolled epilepsy
* History of botulinum toxin injection or surgery in the 6 months preceding the study period or scheduled within 3 months (during the study period)
* Visual or cognitive impairment that may interfere with the management
* Common contraindications to magnetic resonance imaging (MRI) such as metal implants
12 Months
59 Months
ALL
No
Sponsors
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Fondation Paralysie Cérébrale
OTHER
Université Catholique de Louvain
OTHER
University of Pisa
OTHER
University of Lausanne Hospitals
OTHER
University Angers
UNKNOWN
University Hospital, Brest
OTHER
Responsible Party
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Locations
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Les Capucins
Angers, , France
Fondation ILDYS - Site de Ty Yann
Brest, , France
Countries
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References
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Araneda R, Sizonenko SV, Newman CJ, Dinomais M, Le Gal G, Ebner-Karestinos D, Paradis J, Klocker A, Saussez G, Demas J, Bailly R, Bouvier S, Nowak E, Guzzetta A, Riquelme I, Brochard S, Bleyenheuft Y. Protocol of changes induced by early Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (e-HABIT-ILE) in pre-school children with bilateral cerebral palsy: a multisite randomized controlled trial. BMC Neurol. 2020 Jun 12;20(1):243. doi: 10.1186/s12883-020-01820-2.
Other Identifiers
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EARLY_HABIT-ILE (29BRC19.0050)
Identifier Type: -
Identifier Source: org_study_id
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