Cerebral Palsy
Conditions
Interventions
Gross Motor Function Classification System (I-II and III-IV). For each stratum, the randomization sequence will be generated with the distributions appropriately organized and sealed in sequentially n
E02.594.540
Sponsors
Universidade Brasil
Centro de Neuroestimulação Pediátrica
Eligibility
Age
4 Years to 12 Years
Inclusion criteria
Inclusion criteria: Diagnosis of spastic cerebral palsy; functional classification on Levels I, II,III or IV of the Gross Motor Function Classification System (GMFCS); ability to walk independently in at least the previous 12 months, even if requiring a gait-assistance device; age between four and 12 years; both genders; degree of understanding and cooperation compatible with the execution of the proposed activities; 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 |
|---|---|
| It is expected to find an improvement in functional mobility, assessed by the six-minute walk test (meters), demonstrated by a 10% increase in the distance covered in the test after the interventions. Data collected one week before the intervention and one and four weeks after the intervention;It is expected to find an improvement in functional mobility, assessed by the timed up and go test (seconds), demonstrated by a reduction of 3 seconds in the test after the interventions. Data collected one week before the intervention and one and four weeks after the intervention;It is expected to find an improvement in gross motor function, assessed by the Gross Motor Function Measure – 88, demonstrated with a 5% increase in the score after the interventions. Data collected one week before the intervention and one and four weeks after the intervention;It is expected to find an improvement in functional balance, assessed by the Pediatric Balance Scale (points), demonstrated with an increase of 10 points on the scale after the interventions. Data collected one week before the intervention and one and four weeks after the intervention;It is expected to find an improvement in functional performance, assessed by the Pediatric Evaluation of Disability Inventory, demonstrated by an increase of 8 points in the mobility subscale of the test after the interventions. Data collected one week before the intervention and one and four weeks after the intervention;It is expected to find an increase in participation, assessed by the Participation and Environment Measure for Children and Youth demonstrated by a 5% increase in scores after the interventions. Data collected one week before the intervention and one and four weeks after the intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected that no moderate or severe adverse effects will be found during the intervention period, as assessed by a standardized questionnaire that quantifies the perception and intensity of symptoms, demonstrated by the non-reporting of such effects. Data collected before and after each intervention session | — |
Countries
Brazil
Contacts
Public ContactLuanda Collange
Centro de Neuroestimulação Pediátrica
Outcome results
None listed