Stroke Rehabilitation Stroke
Conditions
Interventions
A prospective, randomized, controlled, double-blind clinical trial with 3 parallel groups. Participants will be randomly allocated in a 1:1:1 ratio using computer-generated randomization sequences (Ra
Group 2 – active tDCS combined with placebo FES (tDCS-A/FES-P)
Group 3 – placebo tDCS combined with active FES (tDCS-P/FES-A). Active tDCS will be applied using the NeuroConn DC-Stimulator (NeuroConn GmbH), using 35 cm² (5 × 7 cm) rubber electrodes positioned on
Sponsors
Universidade Federal do Ceará
Universidade Federal de Pernambuco
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Volunteer of both sexes; single case of stroke for at least 6 months; ischemic or hemorrhagic brain injury; age above 18 years; presence of motor sequelae in one hemibody; ability to walk approximately 10 meters on the ground with or without a walking aid; minimum score of 24 points (for individuals with schooling) or 18 points (for individuals with no schooling) on ??the mini-mental state exam
Exclusion criteria
Exclusion criteria: Epilepsy episodes; undiagnosed headache; intracranial metal implant; cardiac pacemaker; pregnancy (or suspected); depression; other clinical conditions of orthopedic, neurological or cardiac origin that do not allow participation in the research
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected outcome 1: Gait performance (total distance covered) will be assessed by the 6-min walk test. It is expected that at the end of the study, there will be an increase of at least 34m in the distance covered in the pre- and post-intervention measurements;Outcome found 1: An improvement in gait performance was observed, assessed by the distance covered during the 6-min walk test, in the three intervention groups: tDCS/FES (17.3 m), FES (31.7 m) and tDCS (28 m) in relation to pre-intervention values. | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected outcome 2: The motor function of the lower limbs will be evaluated by the specific items of the lower limbs of the Fugl-Meyer Rating Scale. It is expected to obtain, at the end of the study, an increase of at least 10 points in the improvement of motor function in the group that received both interventions;Outcome found 2: There was an increase in lower limb motor function, identified by the Fugl-Meyer Assessment Scale in the three intervention groups: tDCS/FES (2.4 points), FES (1.2 points) and tDCS (3.9 points) between the pre- and post-intervention periods.;Expected outcome 3: It is expected to find, at the end of the study, an increase of at least 2.9 seconds in the functional mobility of patients treated with both interventions, using the Time Up and Go (TUG) test.;Outcome found 3: There was an increase in functional mobility, assessed by the reduction in the time taken to perform the Time Up and Go (TUG) test in the three study groups, when comparing the results before and after the intervention: tDCS/FES (-2.59 sec), FES (-2.71 sec) and tDCS (-2.70 sec).;Expected outcome 4: Gait speed will be assessed using the 10-meter walk test. At the end of the study, it is expected to obtain an increase of at least 0.14m/s in the active group for the central and peripheral stimulation;Outcome finding 4: After the intervention period, there was an increase in walking speed (assessed by the 10-meter walk test) in the three study groups: tDCS/FES (0.08 m/s), FES (0.13 m/s) and tDCS (0.03 m/s).;Expected outcome 5: Expected outcome 5: An increase in the volunteers' balance of at least 3 points in the total score of the Mini Balance Evaluation Systems Test (MiniBESTest) is expected, with these values being more significant for the double intervention group.;Outcome found 5: there was an improvement in balance, verified by MiniBESTest, in the three intervention groups: tDCS/FES (1.5 points), FES (2.5 points) and tDCS (1.9 points) between the pre- and post-interven | — |
Countries
BR
Contacts
Public ContactRodrigo Andrade
Universidade Federal do Ceará
Outcome results
None listed