Transcranial Direct Current Stimulation and Functional Electrical Stimulation for Upper-limb 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 FES on upper limb rehabilitation of post-stroke subjects with moderate and severe compromise.

Official Title
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Association Between the Transcranial Direct Current Stimulation (tDCS) and Functional Electrical Stimulation (FES) for Upper-limb Rehabilitation After Stroke - A Randomized Clinical Trial

Conditions
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Stroke

Intervention / Treatment
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* Device: Functional Electrical Stimulation (FES)
* Device: Combination of Transcranial direct brain stimulation (tDCS) and FES


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with ischemic or hemorrhagic stroke diagnosis and moderate or severe hemiparesis (chronic stroke - at least 6 months of disease) Ability to reach 60 degrees in the shoulder flexion Minimal cognitive ability to understand commands No current use of antiepileptic drugs for seizures Exclusion Criteria: Painful shoulder, adhesive capsulitis or glenohumeral subluxation Contraindication for electrical stimulation (presence of metallic implants) or risks for the tDCS, as evaluated by means of a standard questionnaire

Ages Eligible for Study
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Minimum Age: 30 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: Functional electrical stimulation (FES)<br>Chronic stroke patients submitted to functional electrical stimulation (FES). | Device: Functional Electrical Stimulation (FES)<br>* Functional Electrical Stimulation (FES) + Sham Transcranial direct brain stimulation (tDCS)<br>|
| Experimental: Combination of transcranial direct current stimulation and FES<br>Chronic stroke patients submitted to transcranial direct current stimulation (tDCS) and functional and to functional electrical stimulation (FES). | Device: Combination of Transcranial direct brain stimulation (tDCS) and FES<br>* Real Functional Electrical Stimulation (FES) + Real Transcranial direct brain stimulation (tDCS)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Upper-limb reaching analysis evaluated by means of the 3-D motion analysis system (BTS SMART DX 400) | 3-D motion analysis system | Change from Pre to Post 1 (after the 10th session) and Post 3 (3 months follow-up) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Grip force assessed by means of dynamometer | Evaluated by means of dynamometer (Jamar) | Change from Pre to Post 1 (after the 10th session) and Post 3 (3 months follow-up) | 
| Manual dexterity assessed by means of the block and box test | Block and box test | Change from Pre to Post 1 (after the 10th session) and Post 3 (3 months follow-up) | 
| Quality of life assessed by means of the Stroke-Specific Quality of Life (SSQOL) | Questionnaire | Change from Pre to Post 1 (after the 10th session) and Post 3 (3 months follow-up) | 
| Muscular tone assessed by the Modified Ashworth Scale | Modified Ashworth Scale | Change from Pre to Post 1 (after the 10th session) and Post 3 (3 months follow-up) | 
| Assessment of Sensorimotor Recovery After Stroke by the Fugl-Meyer scale | Fugl-Meyer scale | Change from Pre to Post 1 (after the 10th session) and Post 3 (3 months follow-up) | 

 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