The aim of this study is to verify the effectiveness of tDCS combined with foot drop stimulation (FDS) on gait rehabilitation of post-stroke subjects with mild and moderate compromise.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
40
Walkaide is the Foot drop stimulator (FDS) on the peroneal nerve provides active dorsiflexion of muscle during the swing phase of gait.
Transcranial direct brain stimulation on motor cortex
Federal University of Health Sciences of Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Kinematic gait anaysis.
Evaluated by means of the 3-D motion analysis system (BTS SMART DX 400)
Time frame: The outcome will assess at baseline and two weeks after the intervention. One month later that finished the intensive treatment subjects will re-evaluate.
Kinetic gait anaysis.
Assessed by force platform (BTS P-6000)
Time frame: The outcome will assess at baseline and two weeks after the intervention. One month later that finished the intensive treatment subjects will re-evaluate.
Postural Control
Evaluated by Center of Pressure (COP) displacement assessed on force platform (BTS P-6000)
Time frame: The outcome will assess at baseline and two weeks after the intervention. One month later that finished the intensive treatment subjects will re-evaluate.
Functional Mobility
Evaluated by means of the Timed Up \& Go Test (TUG)
Time frame: The outcome will assess at baseline and two weeks after the intervention. One month later that finished the intensive treatment subjects will re-evaluate.
Assessed by means of the Stroke-Specific Quality of Life Questionnaire (SSQOL)
The SSQOL questionnaire assesses the quality of life of stroke subject, and it contains 49 items with 12 domains (energy, family role, language, mobility, mood, personality, self-care, social role, reasoning, upper limb function, vision and work/productivity). There are three possible answers on the 5-point Likert scale. The SSOOL questionnaire score reports a minimum of 49 points and a maximum of 245 points. The lower values represent the more dependence and difficulty to perform tasks.
Time frame: The outcome will assess at baseline and two weeks after the intervention. One month later that finished the intensive treatment subjects will re-evaluate.
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Muscular tone assessed by the Modified Ashworth Scale
Assessed by the Modified Ashworth Scale. This scale consists of 5 ordinal values ranging from 0 (no tonus increase) to 4 (stiffness).
Time frame: The outcome will assess at baseline and two weeks after the intervention. One month later that finished the intensive treatment subjects will re-evaluate.
Assessment of Sensorimotor Recovery After Stroke by Fugl-Meyer scale
Fugl-Meyer scale of lower limb impairment. The evaluation includes measurement of voluntary movement, velocity, coordination and reflex activity, through an ordinal scale applied to each item: 0- cannot be performed, 1- partially performed, and 2-performed completely. Participants were also classified according their LL motor impairment in severe (0 to19), moderate (20 to 28) or mild (\> 29 points).
Time frame: The outcome will assess at baseline and two weeks after the intervention. One month later that finished the intensive treatment subjects will re-evaluate.
Serum levels of Brain-derived neurotrophic fator (BDNF).
The biomarker BDNF will be determined using the enzyme-linked immunosorbent assay (ELISA) method.
Time frame: The outcome will be assessed at baseline and 2 weeks after the intervention.
Serum levels of Insulin-like growth factor binding protein-3 (IGFBP-3)
The biomarker IGFBP-3 will be analyzed in the blood sample to evaluate the neuromuscular adaptations indirectly. Serum IGFBP-3 levels will be determined using the enzyme-linked immunosorbent assay (ELISA) method.
Time frame: The outcome will be assessed at baseline and 2 weeks after the intervention.
Serum levels of insulin-like growth factors 1 (IGF-1)
The IGF-1 will be analyzed in the blood sample to evaluate the neuromuscular adaptations indirectly. Serum IGF-1 levels will be determined using the enzyme-linked immunosorbent assay (ELISA) method.
Time frame: The outcome will be assessed at baseline and 2 weeks after the intervention.