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

University Hospital, Brest42 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Cerebral Palsy

Interventions

Eligibility

Sex: ALLMin age: 12 MonthsMax age: 59 Months

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 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.