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

April 16, 2015 updated by: Suellen Marinho Andrade, Federal University of Paraíba

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Severe functional limitations
  • Cognitive impairment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Paraíba

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

April 14, 2015

First Submitted That Met QC Criteria

April 16, 2015

First Posted (Estimate)

April 21, 2015

Study Record Updates

Last Update Posted (Estimate)

April 21, 2015

Last Update Submitted That Met QC Criteria

April 16, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • tdcs002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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