Down Syndrome
Conditions
Interventions
This is a randomized, placebo-controlled, double-blind clinical trial that will involve 30 children diagnosed with Down Syndrome who will be divided into 2 groups. Experimental group: 15 children will
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 Down syndrome confirmed through clinical examination and genetic investigation; age between three and eight years; both sexes; children who demonstrate sufficient response to understand simple verbal commands; no medication changes at least six months before the start of the study and during its execution; 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 intellectual activities proposed in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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.;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 group receiving active galvanic vestibular stimulation compared to sham galvanic vestibular stimulation.;Participation assessed by the Participation and Environment Measure for Children and Youth (points) performed one week before and one, four and eight weeks after the end of the intervention. It is expected to find an increase in participation, demonstrated by the increase in the score after the interventions.;Adverse effects assessed using a standardized questionnaire that quantifies the perception and intensity of symptoms. Assessments performed before and after each of the ten intervention sessions. It is expected not to find moderate or severe adverse effects during the intervention period. | — |
Countries
Brazil
Contacts
Public ContactLuanda Collange
Centro de Neuroestimulação Pediátrica
Outcome results
None listed