Spastic cerebral palsy
Conditions
Interventions
-This is a two-arm, double-blind, randomized controlled clinical study. Randomization will be carried out using a program capable of generating random numbers to distribute participants to one of the
E05.723.402
Sponsors
Irmandade da Santa Casa de Misericórdia de São Paulo
Centro de Neuroestimulação Pediátrica
Eligibility
Age
6 Years to 12 Years
Inclusion criteria
Inclusion criteria: Diagnosis of Spastic Cerebral Palsy; have magnetic resonance imaging demonstrating damage to the pyramidal system, without involvement of the extrapyramidal system and cerebellum; functionally classified as levels I, II or III by the Gross Motor Function Classification System (GMFCS); degree of spasticity less than three on the Modified Ashworth Scale; able to walk independently for at least 12 months, even if requiring walking aids; aged between six and twelve years; both sexes; degrees of understanding and collaboration compatible with carrying out the proposed activities; guardians agreed to their participation in the study by signing the Free and Informed Consent Form; participant acceptance through the assent form
Exclusion criteria
Exclusion criteria: Children have neurological, neuromuscular diseases or syndromes associated with Cerebral Palsy - CP; 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 |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Vestibular symptoms assessed by the Vanderbilt Pediatric Dizziness Handicap Inventory for patient caregivers questionnaire (points). A decrease in questionnaire points is expected, demonstrating a reduction in vestibular symptoms after interventions.;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.;Gross motor function assessed by the score in the Gross Motor Function Measure – 88 performed 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 gross motor function after the interventions.;Functional performance assessed by the total score of the Pediatric Evaluation of Disability Inventory (self-care, mobility and social function) performed one week before and one, four and eight weeks after the end of the intervention. It is expected to find an increase in the inventory score demonstrating the improvement in functional performance.;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 ContactAmanda Queiróga
Faculdade de Ciências Médicas da Santa Casa de São Paulo
Outcome results
None listed