Spastic Hemiplegic Cerebral Palsy
Conditions
Interventions
This is a triple-blind randomized clinical trial, with an implementation and cost-effectiveness study. A total of 32 patients who meet the inclusion criteria and are clinically cleared for the Transcr
(2) Control Group: for the placebo function, the electrodes will be positioned in the same manner, following identical principles
the device will be turned on after the first 30 seconds of the session so that the patient experiences the initial slight "
tingling"
provided by the current, but no stimulation will be given for the remainder of the session. The CIMT protocol will follow the same procedure as in the intervention group. In both groups, CIMT will be
Sponsors
Universidade Cidade de São Paulo (UNICID)
Associação de Assistência à Criança Deficiente (AACD)
Eligibility
Age
7 Years to 16 Years
Inclusion criteria
Inclusion criteria: Patients diagnosed with Cerebral Palsy – CP of the spastic hemiparesis type; aged between 7 and 16 years; cognitively able to respond to commands requested by the therapist; able to attend the Association for Assistance to Disabled Children – AACD Ibirapuera for 3 weeks, 3 hours/day, 5 days/week; be accompanied throughout the entire protocol by the same caregiver, who participates in the child’s/adolescent’s routine; from a motor standpoint, the patient must be able to perform active movement of the Affected Upper Limb (AUL) with at least 45 degrees of shoulder flexion and abduction, 20 degrees of elbow extension, 10 degrees of wrist extension, and movement of three fingers, including the thumb (grades 2 and 3 of the Active Range of Motion Scale of CIMT); patients classified by the Manual Ability Classification System – MACS at levels I or II; no history of seizure in the last 12 months (patients who previously presented seizures, even if before the established 12 months, will be carefully evaluated by the medical team responsible for performing the Electroencephalogram – EEG for clearance to carry out the protocol); it will also be necessary to sign and complete the Safety Questionnaire prior to the HotSpot mapping procedure by Transcranial Magnetic Stimulation – TMS, to verify that the patient does not have any contraindication to the application of the technique; both gender
Exclusion criteria
Exclusion criteria: Patients who present musculoskeletal deformities that reduce the range of motion of the affected upper limb – AUL in each of the joints (shoulder, elbow, wrist) by more than 10 degrees; who present extensive encephalic lesions or untreated hydrocephalus; who have received botulinum toxin injections in AUL muscles within the last 6 months or have undergone corrective orthopedic surgery of the AUL during this same period; who have metallic implants in the cranial vault region or who have shunt valves with a metallic component
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to find a clinically important difference close to 0.94 for the frequency outcome and 0.74 for the quality outcome of use of the affected upper limb when comparing pre- and post-intervention assessments, as well as their maintenance at the 1-, 3-, and 6-month follow-ups, ascertained through the application of the Pediatric Motor Activity Log Revised (PMAL) or the Teenager Motor Activity Log (TMAL), depending on the age range of the assessed patient | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected to find a clinically important difference between 5 and 6 blocks for the outcome of speed of the affected upper limb when comparing pre- and post-intervention assessments, as well as its maintenance at the 1-, 3-, and 6-month follow-ups, verified through the application of the Box and Blocks Test;It is expected to find a significant difference (values > 0.57 are considered large) for the outcome of spontaneity of use of the affected upper limb when comparing pre- and post-intervention assessments, as well as its maintenance at the 1-, 3-, and 6-month follow-ups, ascertained through the application of the Pediatric Arm Function Test (PAFT);It is expected to find a significant difference (above 2 points of change) for the outcome of performance and satisfaction of use of the affected upper limb when comparing pre- and post-intervention assessments, as well as its maintenance at the 1-, 3-, and 6-month follow-ups, ascertained through the application of the Canadian Occupational Performance Measure (COPM);It is expected to find a significant difference (change of the qualifier to at least +1) for the outcome of the child’s or adolescent’s participation in collaboratively defined goals in which the function of the affected upper limb constituted a barrier, when comparing pre- and post-intervention assessments, as well as its maintenance at the 1-, 3-, and 6-month follow-ups, ascertained through the application of the Goal Attainment Scaling (GAS);In the implementation analysis, it is expected to ascertain that Transcranial Direct Current Stimulation – tDCS – is acceptable, appropriate, and feasible. These outcomes will be assessed using the Weiner scale (5-point Likert scale, in which results greater than or equal to 4 are considered positive), which will be applied at the end of the intervention period to patients and caregivers;In the cost-effectiveness analysis, it is expected that Transcranial Direct Current Stimulation – tDCS associated with Constr | — |
Countries
Brazil
Contacts
Public ContactAndrea Maglione
Universidade Cidade de São Paulo (UNICID)
Outcome results
None listed