Physiotherapy to improve cognition and motor function in people with severe traumatic brain injury.

Category Primary study
Registry of TrialsBrazilian Registry of Clinical Trials
Year 2021
INTERVENTION: 30 individuals will participate. The intervention is Physical Therapy associated with direct transcranial stimulation, 20 minutes each session, totaling 20 sessions. The experimental group will be submitted to the 20‐minute ETCC protocol with an intensity of 2mA, according to the safety protocol described by (BIKSON et al., 2009). The stimulator (DC‐stimulator Plus, Neuroconn, Ilmenau, Germany) will supply direct current through a pair of surface sponge electrodes soaked in saline (electrode size 35cm2). The active electrode (anode) will be applied to the left dorsolateral prefrontal cortex (CPFDLE ‐ F3) according to the international system 10‐20 and the cathode will be positioned over the contralateral supraorbital area (KANG et al., 2012). Participants will be blind to conducting the direct current. The control group will be submitted to the ETCC application protocol (sham). The protocol will follow the same standards as the experimental group, but the current lasts only 30 seconds, characterizing the absence of stimulus. However, the electrodes will remain positioned for 20 minutes, as in the experimental group. Participants will be blind to not conducting the current. The clinical evaluation of the subjects will be performed through the assessment of cognitive and motor function through the application of scales and will take place in the ward of the Hospital de Urgência e Emergência of Vitória‐ES. 15 individuals will be randomized to the experimental group and 15 to the control group. E02.331.800 E02.779 CONDITION: Traumatic Brain Injury (TBI) PRIMARY OUTCOME: Cognitive function which will be assessed through the scales: Mini Mental State Examination (MMSE) and reported in scores ranging from 0 to 30 points, Verbal Fluency which will be reported in counting the number of words reproduced in 60 seconds; Brief Visuospatial Memory Test (VMT) which will be reported by the number of pictures drawn in the correct place, and finally the Beck Depression Inventory (BDI) which will be reported in scores ranging from 0 to 63 points. SECONDARY OUTCOME: Motor function which will be assessed using the scales: Functional Independence Measure (FIM) and reported in scores ranging from 18 to 126, Disability Rating Scale (DRS) and reported in scores ranging from 0 to 29 points, Rancho Los Amigos Scale ‐ Revised (RLAS‐R) and reported at levels ranging from 1 to 10, Glasgow Outcome Scale ‐ Extended (GOS‐E) and reported in any of the 8 categories that classify global outcomes in TBI survivors, and finally the Tardieu Spasticity Scale which will be reported in scores ranging from 0 to 4 points. INCLUSION CRITERIA: Individuals with severe TBI who score on the Glasgow Coma Scale (EGC)
Epistemonikos ID: fc83872ea03512eb05bf40ec548809bfea0ee613
First added on: Aug 25, 2024