Zika virus infection
Conditions
Interventions
Training sessions in modified toy cars will be held three times a week at participants' homes or at the clinic, according to the family's preference. The intervention session will include: (1) setting
2) natural game as a warm-up activity (5 min)
and 3) mobility and social training with cars (30 min). The focus of the treatment sessions will be based on the expected goals of mobility and social function defined by the caregivers in the Goal At
E02.779
Sponsors
Faculdade de Ciências da Saúde do Trairi (FACISA) - Universidade Federal do Rio Grande do Norte (UFRN)
Faculdade de Ciências da Saúde do Trairi (FACISA) - Universidade Federal do Rio Grande do Norte (UFRN)
Eligibility
Age
No minimum to 6 Years
Inclusion criteria
Inclusion criteria: Diagnosis of congenital zika syndrome; Gross Motor Function Classification System (GMFCS) level IV or V; ages between 0 and 6 years; no previous experience with powered mobility.
Exclusion criteria
Exclusion criteria: The presence of uncontrolled seizures and musculoskeletal deformities that prevent adapting the seating support in the device.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A narrative description of study feasibility is expected, including recruitment and retention, protocol adherence, and acceptability. Verified using a mixed methods approach. The Photovoice method and focus groups will be used for qualitative data, in weeks 8 and 12, and for the quantitative methods, the feasibility questionnaires for parents and professionals, which will be used at the end of weeks 4, 8 and 12 of the intervention and in the follow-up.;Evaluate the level of performance in motorized mobility through the Motorized Mobility Use Assessment (ALP), in weeks 0, 4, 8, 12 and 16.;Assess satisfaction with assistive technology device use and services provided through the Quebec Assessment of User Satisfaction with Assistive Technology (QUEST) at weeks 0, 4, 8, 12, and 16. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the total activation time of the trigger button (minutes and seconds) of each 10-minute video, through filming at the end of weeks 4, 8 and 12 of the intervention.;It is expected that parents will report days and minutes of driving time, location, and general driving activities, such as open exploration or playing with a sibling, each day via a Paper Activity Log. Records from weeks 4, 8, and 12 of the intervention and at follow-up will be observed.;Assess mobility skills and social/cognitive functions through the Pediatric Assessment of Disability Inventory - Adaptive Computerized Testing (PEDI-CAT) that will be administered at the beginning and end of the 12th week of the intervention.;Evaluate parents' perspectives on their children's activity frequency, level of involvement and satisfaction with activities, through the Participation and Environment Measure - Young Children (YC-PEM), which will be administered at the beginning and end of the 12th week of the intervention.;Evaluate goal achievement using the Brazilian version of the Goal Attainment Scaling (GAS) at baseline and at the end of the 8th, 12th and 16th week of the intervention.;Evaluate parents' perspectives on their children's frequency of activities, level of involvement and satisfaction with activities, through the Participation and Environment Measure for Children and Youth (PEM-CY), which will be administered at the beginning and end of the 12th intervention week. | — |
Countries
Brazil
Contacts
Public ContactEgmar Longo
Federal University of Rio Grande do Norte
Outcome results
None listed