Transcranial Direct Current Stimulation on the Risk of Falls and Lower Limb Function for Acute Stroke
Phase 2
Completed
- Conditions
- Stroke
- Registration Number
- NCT02422173
- Lead Sponsor
- Federal University of Paraíba
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
- Clinical diagnosis of acute stroke
- Able to walk 10m independently
- High risk of falling
Exclusion Criteria
- Severe functional limitations
- Cognitive impairment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Four Square Step Test Change from Baseline in Risk of Falls at 3 months
- Secondary Outcome Measures
Name Time Method 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