Autism Spectrum Disorder
Conditions
Interventions
A randomized, placebo-controlled, double-blind clinical trial. Randomization will be performed using a program capable of generating random numbers to assign participants to one of the three study int
E02.331.750
Sponsors
Universidade Evangélica de Goiás
Follow Kids - Clinica de Neuro Reabilitação Infantil
Eligibility
Age
3 Years to 8 Years
Inclusion criteria
Inclusion criteria: Diagnosis of autism spectrum disorder; classified as levels I, II and III according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-V); age between three and eight years; comprehension of simple verbal commands; no medication changes at least six months before the beginning of the study and during its performance; statement of informed consent signed by a legal guardian and statement of informed assent signed by the participant
Exclusion criteria
Exclusion criteria: Children that having been submitted to surgical procedures or neurolytic block in the 12 months prior to the onset of the training sessions; orthopedic deformities with indication for surgery; epilepsy; metal implants in skull or hearing aids; intellectual disorder that would limit the execution of the activities proposed in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gross and fine motor skills assessed by the Movement Assessment Battery for Children-2 (percentile) applied one week before and one, four and eight weeks after the end of the intervention. It is expected to find an increase in the percentile of the assessment scale, demonstrating improvement in motor skills, with a greater effect size for groups receiving active transcranial direct current stimulation compared to placebo transcranial direct current stimulation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Functional balance assessed by the Pediatric Balance Scale (points) applied one week before and one, four and eight weeks after the end of the intervention. It is expected to find an increase in the total score of the scale, demonstrating an improvement in functional balance, with a greater effect size for groups receiving active transcranial direct current stimulation compared to placebo transcranial direct current stimulation.;Mobility and functional balance assessed by the execution time of the timed up and go test (seconds) performed one week before and one, four and eight weeks after the end of the intervention. It is expected to find a decrease in the test execution time after the interventions.;Time and space parameters of gate evaluated by the walk test (m/s) performed one week before and one, four and eight weeks after the end of the intervention. It is expected to find an increase in gait speed to perform the test after the interventions.;Motor evoked potential amplitude (microvolts) assessed by transcranial magnetic stimulation synchronized with the electromyograph. Assessments performed one week before and one, four and eight weeks after the end of the intervention. It is expected to find an increase in motor evoked potential amplitude only after the intervention with active transcranial direct current stimulation.;Social behavior, communication and general actions evaluated by the Autism Diagnostic Observation Schedule which is a questionnaire that will be carried out with the professional responsible for the participant's treatment. The questionnaire will be carried out one week before and four and eight weeks after the end of the intervention. It is expected to find a reduction in autistic symptoms observed by professionals after interventions.;Characteristics of autistic behavior evaluated by the Childhood Autism Rating Scale which is an observation scale that will be applied with the person responsible for the participant. The scale will be applied | — |
Countries
Brazil
Contacts
Public ContactLuanda Collange
Centro de Neuroestimulação Pediátrica
Outcome results
None listed