Cerebral Palsy
Conditions
Interventions
This is a randomized, controlled, two-arm clinical trial with a blind evaluator. Families who agree to participate in the study will be randomized to the intervention group or control group. Randomiza
a third party, not part of the research, will have access to this list and will prepare the sealed manila envelopes containing the allocation of patients. The sample will consist of 30 children (and t
the intervention group will additionally receive functional home therapy with a family-centered approach every two weeks for 3 months. In this approach, there is the establishment of a therapist-famil
N01.400.300
Sponsors
Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (FMRP-USP)
Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (FMRP-USP)
Eligibility
Age
No minimum to 6 Years
Inclusion criteria
Inclusion criteria: Children with a previous diagnosis of cerebral palsy or at high risk of delay in neuropsychomotor development identified from screening by the Hammersmith Child Neurological Examination - HINE; age group 0-6 years; both genders; parents' agreement to participate in the research by signing the Free and Informed Consent Form; be undergoing physiotherapeutic treatment previously
Exclusion criteria
Exclusion criteria: Child with a different diagnosis of cerebral palsy; children with difficult-to-control epilepsy; children with other syndromes associated with cerebral palsy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| We expect to find an improvement in performance in carrying out an activity (goal) by the child and in the parents' satisfaction with this performance, measured by the increase of two or more scores in the Canadian Occupational Performance Measure (COPM), evaluated in the pre and post-intervention.;We expect to find an improvement of at least 5% in the perception of quality of life related to the health of parents/main caregivers, assessed by the Pediatric Quality of Life Inventory - Family Module (PedsQL), applied before and after the intervention.;We expect to find an improvement in the functional profile in the self-care, mobility and social function domains, represented by an increase of at least 5% in the score on the Pediatric Assessment of Disability Inventory (PEDI) compared to the baseline measure and that the score be between scores 30-70 of the normative score after the intervention. | — |
Secondary
| Measure | Time frame |
|---|---|
| We expect to find a high perception of parents about the application of the principles of family-centered practice after intervention , evaluated through the Measure of Processes of Care - 20 (MPOC-20), at least 5% higher than the baseline MPOC-20 score.;We expect to find improvement in the gross motor function, represented by the increase in the total score by 5% in the Gross Motor Function Measure - 66 (GMFM-66) evaluated before and after the intervention. | — |
Countries
Brazil
Contacts
Public ContactLarissa Mota
Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (FMRP-USP)
Outcome results
None listed