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 Overview
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Brief Summary
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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
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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).

Official Title
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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

Conditions
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Cerebral Palsy

Intervention / Treatment
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* Other: MRI
* Other: Electro-Encephalography-High Density (children with unilateral PC only)
* Other: 3D and EMG analysis
* Other: care and classic activities
* Device: Accelerometers


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Months
Maximum Age: 59 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventional<br>10 days of intensive and structured motor therapy, 5 hours a day = 50h | Other: MRI<br>* MRI at baseline and J90<br>Other: Electro-Encephalography-High Density (children with unilateral PC only)<br>* Electro-Encephalography-High Density (children with unilateral PC only) at baseline and J90<br>Other: 3D and EMG analysis<br>* 3D and EMG analysis at baseline and J90<br>Other: care and classic activities<br>* physiotherapy and psychomotility. As needed weekly sessions of speech therapist or orthoptist and daily activities of the child.<br>Device: Accelerometers<br>* During 5 days a sensor at each wrist to quantify their movement.<br>|
| Placebo Comparator: Control<br>10 days of care and classic activities | Other: MRI<br>* MRI at baseline and J90<br>Other: Electro-Encephalography-High Density (children with unilateral PC only)<br>* Electro-Encephalography-High Density (children with unilateral PC only) at baseline and J90<br>Other: 3D and EMG analysis<br>* 3D and EMG analysis at baseline and J90<br>Other: care and classic activities<br>* physiotherapy and psychomotility. As needed weekly sessions of speech therapist or orthoptist and daily activities of the child.<br>Device: Accelerometers<br>* During 5 days a sensor at each wrist to quantify their movement.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assistive Hand Assesment (AHA/miniAHA) (for unilateral CP only) | measures and describes how children with upper limb disability in one hand use his/her affected hand collaboratively with the non affected hand in bimanual play.The score range from 0 to 100 as a percentage. 100 is the best outcome. | 1 hour | 
| Gross Motor Function Measure (GMFM) (for bilateral CP only) | measures change in gross motor function over time in children with cerebral palsy. The score range from 0 to 100 as a percentage. 100 is the best outcome. | 1 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cerebral Palsy (CP), pre-school children with unilateral and bilateral CP