children with spastic diplegic cerebral palsy
Conditions
Interventions
Experimental group Cz: 10 children diagnosed with diplegic spastic cerebral palsy who will undergo treadmill training associated with anodic transcranial direct current stimulation (1mA, 20minutes) in
Experimental group Cb: 10 children diagnosed with diplegic spastic cerebral palsy who will undergo treadmill training associated with anodic transcranial direct current stimulation (1mA, 20minutes) in
Control group: 10 children diagnosed with diplegic spastic cerebral palsy who will undergo treadmill training associated with anodic transcranial direct current stimulation (0mA, 20minutes) in the reg
Behavioural
E02.331
E01.370.600.250
Sponsors
Universidade de Sorocaba
Faculdade de Ciências Médicas da Santa Casa de São Paulo
Centro de Neuroestimulação Pediátrica
Vento Leste - Habilitação Infantil Especializada
Eligibility
Age
5 Years to 15 Years
Inclusion criteria
Inclusion criteria: The children will be screened for participation in the study according to the following criteria:diagnosis of spastic CP confirmed by clinical examination; to obtain magnetic resonance imaging of the brain performed no more than two years before the beginning of the intervention; demonstrating lesion in the pyramidal system; without compromising the extrapyramidal system and cerebellum; age between five and 15 years; children levels I, II and III of GMFCS; children who have a muscular form degree equal to or greater than three in the flexor and extensor muscles of the trunk, hips and knees; degree of spasticity of less than three in the Modified Ashworth Scale; agreement of those responsible by signing the Term of Free and Informed Consent.
Exclusion criteria
Exclusion criteria: Children will be excluded if are diagnosed with epilepsy or have had seizures at least 12 months before the beginning of the study, present neurological, neuromuscular or syndromic diseases associated with brain injury; have undergone orthopedic or neurological surgeries in the 12 months prior to the intervention; have undergone neurolithic blockade in the 12 months prior to intervention; present orthopedic deformities with surgical indication; have brain implants or have performed some neurosurgical procedure; have metallic implants in the regions of head, neck, thorax and / or upper limbs, have hearing aids; children with a degree of collaboration incompatible with the adequate performance in the activities proposed in this project.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in walking speed, evaluation by the G-WALK inertial sensor 1 week before the intervention, 1 week after an intervention, 1 month after the intervention and 3 months after the intervention. Effect considered for sample calculation: • Gait speed: experimental group: 0.9 ± 0.1m / s and control group: 0.6 ± 0.1m / s;;The improvement in functional mobility, evaluated by the 6-minute walk test and the Timed Up and Go test 1 week before the intervention, before and after each intervention, 1 week after the intervention, 1 month after the intervention and 3 months after the intervention . Effect considered for sample calculation: • Functional mobility assessed by the six-minute walk test: experimental group: 448.2 ± 100.5m and control group: 367.2 ± 97.6m; | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in functional performance, assessed by the Pediatric Disability Inventory (PEDI) 1 week before the intervention, 1 week after the intervention, 1 month after the intervention and 3 months after the intervention. ;The improvement in gross motor function, through the Gross Motor Function Measure (GMFM-66) 1 week before the intervention, 1 week after the intervention, 1 month after the intervention and 3 months after the intervention. Effect considered for sample calculation: • Gross motor function assessed by the Gross Motor Function Measurement: experimental group: 75.4 ± 11.6 and control group: 70.0 ± 9.2;;The improvement of the functional balance, evaluated by the Pediatric Balance Scale 1 week before the intervention, 1 week after the intervention, 1 month after the intervention and 3 months after the intervention. Effect considered for sample calculation: • Functional balance assessed by the Pediatric Balance Scale: experimental group: 45.3 ± 7.9 and control group: 39.7 ± 9.8;;The improvement in treadmill exercise test, evaluated by the modified Bruce protocol 1 week before the intervention, 1 week after the intervention, 1 month after the intervention and 3 months after the intervention. ;The report of potential adverse effects of transcranial electrostimulation by direct current, evaluated at each session through a questionnaire applied with the child. | — |
Countries
Brazil
Contacts
Public ContactLucas Villalta Santos
Faculdade de Ciências Médicas da Santa Casa de São Paulo
Outcome results
None listed