Transcranial Direct Current Stimulation on the Risk of Falls and Lower Limb Function for Acute Stroke

Study Overview
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Brief Summary
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Transcranial direct current stimulation (tDCS) has shown promising results in the modulation of cortical excitability and the promotion of neuronal plasticity after stroke. The purpose of this study was to compare the effectiveness of three different montages of tDCS (anodal, cathodal and bilateral) in reducing the risk of falls and recovery of lower limb function in acute stroke patients.

Detailed Description
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This is a randomized sham-controlled trial reported following the 2010 CONSORT guidelines. The subjects were randomly allocated into 1 of 4 groups in a double-blinded parallel study design. Each patient received 10 sessions (5 consecutive days for 2 weeks) of real or sham stimulation at 2 mA intensity and current density equivalent to 0.05 A/m2.

Official Title
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Effects of Different Montages of Transcranial Direct Current Stimulation on the Risk of Falls and Lower Limb Function for Acute Stroke Patients: a Randomized Controlled Trial

Conditions
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Stroke

Intervention / Treatment
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* Device: Anodal transcranial direct current stimulation
* Device: Cathodal transcranial direct current stimulation
* Device: Bilateral transcranial direct current stimulation
* Device: Sham transcranial direct current stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of acute stroke Able to walk 10m independently High risk of falling Exclusion Criteria: Severe functional limitations Cognitive impairment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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 |
| --- | --- |
| Experimental: Anodal tDCS<br>Participants in the acute post-stroke stage will receive anodal transcranial direct current stimulation | Device: Anodal transcranial direct current stimulation<br>* The active electrode is placed on the affected hemisphere<br>|
| Experimental: Cathodal tDCS<br>Participants in the acute post-stroke stage will receive cathodal transcranial direct current stimulation | Device: Cathodal transcranial direct current stimulation<br>* The active electrode is placed on the unaffected hemisphere<br>|
| Experimental: Bilateral tDCS<br>Participants in the acute post-stroke stage will receive bilateral transcranial direct current stimulation | Device: Bilateral transcranial direct current stimulation<br>* The cathode and anode is positioned as active electrodes on the unaffected and affected hemisphere,respectively.<br>|
| Sham Comparator: Sham tDCS<br>Participants in the acute post-stroke stage will receive sham transcranial direct current stimulation | Device: Sham transcranial direct current stimulation<br>* Placebo stimulation, with emission current by only 30 seconds<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Four Square Step Test |  | Change from Baseline in Risk of Falls at 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of Falling Index |  | Baseline, Week 2, Week 4 and Week 12 | 
| Overall Stability Index |  | Baseline, Week 2, Week 4 and Week 12 | 
| Falls Efficacy Scale - International |  | Baseline, Week 2, Week 4 and Week 12 | 
| Berg Balance Scale |  | Baseline, Week 2, Week 4 and Week 12 | 
| Six-minute walk test |  | Baseline, Week 2, Week 4 and Week 12 | 
| Sit to Stand Test |  | Baseline, Week 2, Week 4 and Week 12 |