Association Between the tDCS and FDS for Gait Rehabilitation After Stroke

Study Overview
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Brief Summary
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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.

Official Title
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Association Between the Transcranial Direct Current Stimulation (tDCS) and Foot Drop Stimulation (FDS) for Gait Rehabilitation After Stroke - A Randomized Clinical Trial

Conditions
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Stroke

Intervention / Treatment
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* Device: Foot Drop Stimulatio - Neuro Orthosis
* Device: Transcranial direct brain stimulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ShamtDCS+FDS<br>Chronic stroke patients submitted to Foot Drop Stimulation (FDS) + Sham Transcranial direct brain stimulation (tDCS) | Device: Foot Drop Stimulatio - Neuro Orthosis<br>* Walkaide is the Foot drop stimulator (FDS) on the peroneal nerve provides active dorsiflexion of muscle during the swing phase of gait.<br>|
| Experimental: tDCS+FDS<br>Chronic stroke patients submitted to Foot Drop Stimulation (FDS) + Transcranial direct brain stimulation (tDCS) | Device: Foot Drop Stimulatio - Neuro Orthosis<br>* Walkaide is the Foot drop stimulator (FDS) on the peroneal nerve provides active dorsiflexion of muscle during the swing phase of gait.<br>Device: Transcranial direct brain stimulation<br>* Transcranial direct brain stimulation on motor cortex<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cerebrovascular Accident, Cerebrovascular Stroke, Cerebral Stroke