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

Phase 2

Completed

• Conditions: Stroke
• Interventions: Device: Anodal transcranial direct current stimulation; Device: Cathodal transcranial direct current stimulation; Device: Sham transcranial direct current stimulation; Device: Bilateral transcranial direct current stimulation

• 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.

Study Timeline

• Study Start: 2015-01
• Primary Completion: 2015-03
• Status Verified: 2015-04
• Study Completion: 2015-04
• Study First Submitted: 2015-04-14
• Study First Submitted QC: 2015-04-16
• Last Update Submitted: 2015-04-16
• Study First Posted: 2015-04-21
• Last Update Posted: 2015-04-21

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

Arm && Interventions

Group	Intervention	Description
Anodal tDCS	Anodal transcranial direct current stimulation	Participants in the acute post-stroke stage will receive anodal transcranial direct current stimulation
Cathodal tDCS	Cathodal transcranial direct current stimulation	Participants in the acute post-stroke stage will receive cathodal transcranial direct current stimulation
Sham tDCS	Sham transcranial direct current stimulation	Participants in the acute post-stroke stage will receive sham transcranial direct current stimulation
Bilateral tDCS	Bilateral transcranial direct current stimulation	Participants in the acute post-stroke stage will receive bilateral transcranial direct current stimulation

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