One of the urgent priorities in the field of pediatric neuro-rehabilitation is the development of efficient early motor interventions for children with cerebral palsy (CP). Animal studies suggest that early intensive interventions are likely to have a significant impact on the organization of the brain and corticospinal tracts, reducing motor impairments and their medium and long-term consequences in children with cerebral palsy. Although most of the growth, development and cortical organization takes place in the time course of the first 2 years of life, most studies investigating the effectiveness of intensive rehabilitation and associated neurophysiological mechanisms have been conducted in school-aged children (\> 6 years). In addition, the vast majority of these studies were conducted in children with unilateral CP, while the bilateral form of the pathology has the highest prevalence. It is therefore a priority to investigate the effectiveness of early interventions on the overall motor function of children with CP, especially in children with bilateral form of CP. Hand and Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) makes it possible to apply the concepts of structured motor learning and intensive treatment to both the upper limbs and the lower limbs and demonstrated improvements at both levels in school-aged children with unilateral CP and bilateral and then at all three International Classification of Functioning and Disability levels. The principles and content of HABIT-ILE can be applied to pre-school children and this method is promising for early neuro-rehabilitation.
The main objective of this study is to evaluate the effect of 10 days (i.e. 50 hours) of early HABIT-ILE (HABIT-ILE) on the overall motor function of children aged 1 to 4 with bilateral cerebral palsy in comparison to 10 days (50h) of spontaneous overall motor activity including usual rehabilitation (control group).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
36
MRI at baseline and J90
Electro-Encephalography-High Density (children with unilateral PC only) at baseline and J90
3D and EMG analysis at baseline and J90
physiotherapy and psychomotility. As needed weekly sessions of speech therapist or orthoptist and daily activities of the child.
Les Capucins
Angers, Angers, France
Fondation ILDYS - Site de Ty Yann
Brest, Brest, France
Gross Motor Function Measure (GMFM)
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.
Time frame: 1 hour
Both Hands Assessment
Assess the extent to which the more severely affected hand can assist during two-handed activities
Time frame: up to 90 days
Melbourne Assessment 2
Assess the quality of movement in children with neurological disorders
Time frame: up to 90 days
ACTIVLIM-CP
Assess the child's overall performance during daily activities.
Time frame: up to 90 days
Young Children's Participation and Environment Measure
Assess the participation of young children with disabilities and delays in terms of patterns of participation at home, in daycare/preschool, and in the community; perceived environmental supports and barriers to participation; and activity-specific parenting strategies to promote participation
Time frame: up to 90 days
Pediatric Evaluation of Disability Inventory Computer Adaptive Test
assess functional abilities in four areas: activities of daily living, mobility, social/cognitive functioning, and self-care.
Time frame: up to 90 days
Canadian Occupational Performance Measure
define therapeutic goals and measure the child's progress and the parents' level of satisfaction for each functional goal.
Time frame: up to 90 days
Visual-spatial functions
Assessment of tracking ability, visual field exploration, and oculomotor coordination using the assessment kit developed by Prof. Chokron of the Adolphe de Rothschild Ophthalmological Foundation in Paris, France
Time frame: up to 90 days
Healthcare Economic Analysis
to demonstrate the effectiveness of early intensive rehabilitation compared to traditional care through a cost-effectiveness study
Time frame: through study completion
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