Cerebral Palsy
Conditions
Interventions
This is a randomized, controlled, two-arm clinical trial. Screening: Infants, along with their families, at three months of chronological age for full-term infants and corrected age for preterm infant
2) classification in the General Movement Assessment (GMs) as mild or clearly abnormal, according to the classification proposed by Hadders-Algra
3) score below 57 points on the Hammersmith Infant Neurological Examination (HINE). Sample size: A total of 36 previously screened infants at risk of cerebral palsy will be recruited. Randomization: I
2. Shared intervention planning
3. Shared implementation
E02.779
Sponsors
Universidade Federal de Minas Gerais
Universidade Federal de Minas Gerais
Eligibility
Age
3 Months to 5 Months
Inclusion criteria
Inclusion criteria: Infants born at term or preterm aged three to five months corrected age for preterm infants and three to five months of chronological age for term infants at high risk of cerebral palsy
Exclusion criteria
Exclusion criteria: Children with clinical instability, tracheostomy or oxygen dependents
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate the parents' perception of changes in the child's performance and parental satisfaction with the child's performance over time through the Canadian Occupational Performance Measure (COPM), which consists of a semi-structured interview, in which parents identify a series of areas they would like to prioritize with their child, using a score of 1 to 10 points to assess the importance, satisfaction and performance in relation to each chosen priority. 3 to 5 priorities will be established in this study. It will be applied with the children's parents at the beginning of the intervention, at the end of the intervention and in the follow-up.;Evaluate the child's motor and cognitive development through the Bayley III Child Development Scale, which consists of an instrument for assessing the development of children aged 1 to 42 months, consisting of five domains: cognition, language (receptive and expressive communication), motor (coarse and fine), socioemotional and adaptive behavior. The assessment is carried out individually, lasting about 50 minutes. In the present study, only the motor and cognitive domains will be used to assess motor and cognitive development outcomes. The motor domain is divided into two scales, Gross Motor with 72 items and Fine Motor with 66 items. The cognitive domain consists of a 91-item scale. The score for each item is 1 (credited) or 0 (not credited). The raw score is generated by the sum of the items performed by the child. The composite score will be used, with normative data for age, where the average score is 100, with a standard deviation of ±15 points. Children will be categorized as delayed when they receive a score of less than 85 points and as typical or normal development when they have a score equal to or greater than 85 points. It will be applied with the child at the beginning of the intervention, at the end of the intervention and in the follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the achievement of the goals established by the parents through the Goal Attainment Scaling (GAS), which consists of an individualized measure that quantifies the progress and performance in relation to a pre-defined goal, through five possible results specified for the goal, whose scores evaluate changes over time. It is a performance measurement scale that ranges from -2 to +2, where '-2' indicates the current level of the child's performance, '-1' performance below expectations, '0' achievement of the defined goal and, '+ 1' and '+2' different degrees of overcoming the defined goal. The scores achieved in the GAS will be converted into a T-score, considering a mean of 50 and a standard deviation of 10. In addition, the levels of importance and difficulty of each goal will be verified using a scale from 0 to 3. In the present study, parents will be encouraged to identify 3-5 goals for the 12-week intervention period.;Evaluate the child's performance in daily, mobility and social/cognitive activities through the Pediatric Evaluation of Disability Inventory - Computer Adaptive Test (PEDI-CAT) measure, which consists of a standardized test that uses adaptive computerized testing and evaluates the performance of activities and participation, divided into four domains: 'daily activities', 'mobility', 'social/cognitive' and 'responsibility'. The test will be completed through interviews with the parents of the participating babies, with records of continuous scores for each domain. In the present study, the longer “understandable” (Content-Balanced) version will be used, with about 30 items per domain, and the domains 'daily activities', 'mobility' and 'social/cognitive' will be considered. It will be applied with the children's parents at the beginning of the intervention, at the end of the intervention and in the follow-up.;Evaluate parents' perception of participation at home, at school and in the community through the Young Children's Participation and Envi | — |
Countries
Brazil
Contacts
Public ContactAna Cristina ;Agnes Camargos;Santos da Cunha
Universidade Federal de Minas Gerais;Universidade Federal de Minas Gerais
Outcome results
None listed