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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ShamtDCS+FDS | Active Comparator | Chronic stroke patients submitted to Foot Drop Stimulation (FDS) + Sham Transcranial direct brain stimulation (tDCS) |
|
| tDCS+FDS | Experimental | Chronic stroke patients submitted to Foot Drop Stimulation (FDS) + Transcranial direct brain stimulation (tDCS) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Foot Drop Stimulatio - Neuro Orthosis | Device | Walkaide is the Foot drop stimulator (FDS) on the peroneal nerve provides active dorsiflexion of muscle during the swing phase of gait. |
| Measure | Description | Time Frame |
|---|---|---|
| Kinematic gait anaysis. | Evaluated by means of the 3-D motion analysis system (BTS SMART DX 400) | The outcome will assess at baseline and two weeks after the intervention. One month later that finished the intensive treatment subjects will re-evaluate. |
| Measure | Description | Time Frame |
|---|---|---|
| Kinetic gait anaysis. | Assessed by force platform (BTS P-6000) | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aline S Pagnussat, PhD | Federal University of Health Sciences of Porto Alegre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federal University of Health Sciences of Porto Alegre | Porto Alegre | Rio Grande do Sul | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35689805 | Derived | da Cunha MJ, Pinto C, Schifino GP, Sant'Anna Py I, Cimolin V, Pagnussat AS. Bicephalic Transcranial Direct-Current Stimulation Does Not Add Benefits to a Footdrop Stimulator for Improving Functional Mobility in People With Chronic Hemiparesis After Stroke: A Double-Blind, Randomized Controlled Trial. Phys Ther. 2022 Aug 4;102(8):pzac079. doi: 10.1093/ptj/pzac079. |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Transcranial direct brain stimulation | Device | Transcranial direct brain stimulation on motor cortex |
|
Evaluated by Center of Pressure (COP) displacement assessed on force platform (BTS P-6000)
| 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) | 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. | The outcome will assess at baseline and two weeks after the intervention. One month later that finished the intensive treatment subjects will re-evaluate. |
| 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). | 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). | 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. | 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. | 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. | The outcome will be assessed at baseline and 2 weeks after the intervention. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |