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Clinical Trials/NCT02422173
NCT02422173
Completed
Phase 2

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

Federal University of Paraíba0 sites60 target enrollmentJanuary 2015
ConditionsStroke

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Stroke
Sponsor
Federal University of Paraíba
Enrollment
60
Primary Endpoint
Four Square Step Test
Status
Completed
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2015
End Date
April 2015
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Federal University of Paraíba
Responsible Party
Principal Investigator
Principal Investigator

Suellen Marinho Andrade

Professor, PhD

Federal University of Paraíba

Eligibility Criteria

Inclusion Criteria

  • Clinical diagnosis of acute stroke
  • Able to walk 10m independently
  • High risk of falling

Exclusion Criteria

  • Severe functional limitations
  • Cognitive impairment

Outcomes

Primary Outcomes

Four Square Step Test

Time Frame: Change from Baseline in Risk of Falls at 3 months

Secondary Outcomes

  • Berg Balance Scale(Baseline, Week 2, Week 4 and Week 12)
  • 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)
  • Six-minute walk test(Baseline, Week 2, Week 4 and Week 12)
  • Sit to Stand Test(Baseline, Week 2, Week 4 and Week 12)

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