Stroke
Conditions
Keywords
Cerebrovascular Accident, Cerebrovascular Stroke, Cerebral Stroke
Brief summary
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.
Interventions
DEVICEFoot Drop Stimulatio - Neuro Orthosis
Walkaide is the Foot drop stimulator (FDS) on the peroneal nerve provides active dorsiflexion of muscle during the swing phase of gait.
DEVICETranscranial direct brain stimulation
Transcranial direct brain stimulation on motor cortex
Sponsors
Federal University of Health Science of Porto Alegre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects with ischemic or hemorrhagic stroke diagnosis. * Mild, moderate or severe hemiparesis (chronic stroke - at least 6 months) * Minimal cognitive ability to understand commands * Able to walk 10 meters unassisted or with minimal assistance
Exclusion criteria
* No current use of antiepileptic drugs for seizures * Secondary musculoskeletal disorder involving the lower limb * Contraindication for electrical stimulation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Kinematic gait anaysis. | The outcome will assess at baseline and two weeks after the intervention. One month later that finished the intensive treatment subjects will re-evaluate. | Evaluated by means of the 3-D motion analysis system (BTS SMART DX 400) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postural Control | The outcome will assess at baseline and two weeks after the intervention. One month later that finished the intensive treatment subjects will re-evaluate. | Evaluated by Center of Pressure (COP) displacement assessed on force platform (BTS P-6000) |
| Functional Mobility | The outcome will assess at baseline and two weeks after the intervention. One month later that finished the intensive treatment subjects will re-evaluate. | Evaluated by means of the Timed Up & Go Test (TUG) |
| Assessed by means of the Stroke-Specific Quality of Life Questionnaire (SSQOL) | The outcome will assess at baseline and two weeks after the intervention. One month later that finished the intensive treatment subjects will re-evaluate. | 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. |
| Muscular tone assessed by the Modified Ashworth Scale | 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 the Modified Ashworth Scale. This scale consists of 5 ordinal values ranging from 0 (no tonus increase) to 4 (stiffness). |
| Kinetic gait anaysis. | 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 force platform (BTS P-6000) |
| Serum levels of Brain-derived neurotrophic fator (BDNF). | The outcome will be assessed at baseline and 2 weeks after the intervention. | The biomarker BDNF will be determined using the enzyme-linked immunosorbent assay (ELISA) method. |
| Serum levels of Insulin-like growth factor binding protein-3 (IGFBP-3) | The outcome will be assessed at baseline and 2 weeks after the intervention. | 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. |
| Serum levels of insulin-like growth factors 1 (IGF-1) | The outcome will be assessed at baseline and 2 weeks after the intervention. | 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. |
| Assessment of Sensorimotor Recovery After Stroke by Fugl-Meyer scale | The outcome will assess at baseline and two weeks after the intervention. One month later that finished the intensive treatment subjects will re-evaluate. | 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). |
Countries
Brazil
Outcome results
None listed