Stroke, not specified as haemorrhage or infarction
Conditions
Interventions
This is a double-blind randomized study. Patients who have experienced a stroke with lower limb impairment will undergo transcranial magnetic stimulation followed by a gait training protocol on a robo
Sponsors
Centro de Reabilitação Física do Espírito Santo (CREFES)
Universidade Federal do Espírito Santo (UFES) - Biotecnologia
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Over 18 years of age; patients with gait dysfunction resulting from stroke; clinically stable; good understanding and ability to follow the researchers’ instructions; willing to participate in the study and sign the informed consent form
Exclusion criteria
Exclusion criteria: Clinical instability; inability to maintain orthostasis; use of a pacemaker; uncontrolled epilepsy; skin disease at the stimulation site; lower limb orthopedic condition that limits gait; severe osteoporosis; score of grade 4 on the Ashworth Scale (fixed muscle/joint contracture) in the lower limb; lower limb amputation; active vascular thrombosis in the lower limb; severe heart failure; inability to adapt to the motor imagery–brain–computer interface; decompressive craniectomy; severe cognitive impairment; severe visual impairment; severe hearing impairment; severe sensory impairment of the lower limbs; decompensated psychiatric disorder; severe dizziness; severe lower limb ataxia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected that patients undergoing the protocol with real Transcranial Magnetic Stimulation will achieve greater gains in gait speed on the treadmill and in clinical tests, as well as a reduction in the number of steps required to complete the 10-Meter Walk Test, compared with the sham (placebo) group. | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected that volunteers who undergo real Transcranial Magnetic Stimulation will exhibit greater cerebral neuroplasticity, evidenced by more pronounced regional changes in the cortical motor map and increased brainwave amplitude as measured by electroencephalography, compared with the sham (placebo) group.;It is expected that all volunteers undergoing the protocol will regain walking ability after the stroke, as evidenced by increased treadmill speed and improved performance on the clinical test, as well as a reduction in the number of steps required to complete the 10-Meter Walk Test, in both the real and sham groups.;It is expected that patients in the real Transcranial Magnetic Stimulation group will exhibit lower methylation levels of the Brain-Derived Neurotrophic Factor (BDNF) gene, indicating greater neuroplasticity induced by the technique, compared with the sham (placebo) group | — |
Countries
Brazil
Contacts
Public ContactFernando Cabral
Centro de Reabilitação Física do Espírito Santo (CREFES)
Outcome results
None listed