Cerebral Palsy
Conditions
Keywords
cerebral palsy (CP), pre-school children with bilateral CP
Brief summary
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.
Detailed description
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).
Interventions
OTHERMRI
MRI at baseline and J90
OTHERElectro-Encephalography-High Density
Electro-Encephalography-High Density (children with unilateral PC only) at baseline and J90
OTHER3D and EMG analysis
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.
Sponsors
University Hospital, Brest
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
12 Months to 59 Months
Healthy volunteers
No
Inclusion criteria
* Child with bilateral cerebral palsy proven to be spastic or dyskinetic * 1 to 4 years old inclusive (12 to 59 months) (age corrected if premature) able to follow instructions and to be able to carry out all the assessments, in accordance with his age * Being matched to a child according to age, etiology of CP / classification of motor function (GMFCS) * Signature of consent by the two holders of parental authority
Exclusion criteria
* Exceed 4 years and 11 months (59 months) during the internship evaluation period. * Uncontrolled epilepsy. * History of toxin injection or surgery in the 6 months preceding the study period or scheduled within 3 months (during the study period). * Visual or cognitive deficit preventing the child from seeing the games and interacting * Usual contraindications to magnetic resonance imaging (MRI) such as metal implants.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gross Motor Function Measure (GMFM) | 1 hour | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Both Hands Assessment | up to 90 days | Assess the extent to which the more severely affected hand can assist during two-handed activities |
| Melbourne Assessment 2 | up to 90 days | Assess the quality of movement in children with neurological disorders |
| ACTIVLIM-CP | up to 90 days | Assess the child's overall performance during daily activities. |
| Young Children's Participation and Environment Measure | up to 90 days | 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 |
| Pediatric Evaluation of Disability Inventory Computer Adaptive Test | up to 90 days | assess functional abilities in four areas: activities of daily living, mobility, social/cognitive functioning, and self-care. |
| Canadian Occupational Performance Measure | up to 90 days | define therapeutic goals and measure the child's progress and the parents' level of satisfaction for each functional goal. |
| Visual-spatial functions | up to 90 days | 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 |
| Healthcare Economic Analysis | through study completion | to demonstrate the effectiveness of early intensive rehabilitation compared to traditional care through a cost-effectiveness study |
Countries
France
Outcome results
None listed