Clinical trial NCT04017871: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: Cerebral Palsy (CP)
pre-school children with unilateral and bilateral CP
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
Collaborators: name: Fondation Paralysie Cérébrale
name: Université Catholique de Louvain
name: University of Pisa
name: University of Lausanne Hospitals
name: University Angers
First posted: 2019-07-12
Enrollment: 42
Sex: ALL
Minimum age (years): 12
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: An urgent priority in the field of paediatric neurorehabilitation is the development of effective early motor interventions.

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.

Detailed description: The primary objective of this study is to evaluate the effect of two weeks of early HABIT-ILE on gross motor function in pre-school children with unilateral and and bilateral Cerebral Paralysy (CP), in comparison with two weeks of usual motor activity including usual rehabilitation (control group).

Eligibility criteria: Inclusion Criteria:

* Child with unilateral cerebral palsy or Child with bilateral cerebral palsy proven spastic or dyskinetic
* 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:

* Age\> 2 years old (35 months) or 4 years old (59 months) during the internship evaluation period
* 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

Primary outcomes:
measure: Assistive Hand Assesment (AHA/miniAHA) (for unilateral CP only)
timeFrame: 1 hour
measure: Gross Motor Function Measure (GMFM) (for bilateral CP only)
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: Les Capucins
city: Brest
country: France
facility: Fondation ILDYS - Site de Ty Yann
Study officials:
References:
citation: 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.