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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional | Experimental | 10 days of intensive and structured motor therapy, 5 hours a day = 50h |
|
| Control | Placebo Comparator | 10 days of care and classic activities |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRI | Other | MRI at baseline and J90 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Both Hands Assessment | Assess the extent to which the more severely affected hand can assist during two-handed activities | up to 90 days |
| Melbourne Assessment 2 | Assess the quality of movement in children with neurological disorders |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Les Capucins | Angers | Angers | 49000 | France | ||
| Fondation ILDYS - Site de Ty Yann |
All collected data that underlie results in a publication
Data will be available after the publication of result and ending fifteen years following the last visit of the last patient
Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.
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| Electro-Encephalography-High Density |
| Other |
Electro-Encephalography-High Density (children with unilateral PC only) at baseline and J90 |
|
| 3D and EMG analysis | Other | 3D and EMG analysis at baseline and J90 |
|
| care and classic activities | Other | physiotherapy and psychomotility. As needed weekly sessions of speech therapist or orthoptist and daily activities of the child. |
|
| up to 90 days |
| ACTIVLIM-CP | Assess the child's overall performance during daily activities. | 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 | 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. | 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. | 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 | up to 90 days |
| Healthcare Economic Analysis | to demonstrate the effectiveness of early intensive rehabilitation compared to traditional care through a cost-effectiveness study | through study completion |
| Brest |
| Brest |
| 29000 |
| France |
| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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