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Completed

NCT Number: NCT02422173

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

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Severe functional limitations
  • Cognitive impairment

Treatment and study plan

anodal transcranial direct current stimulation

Device

The active electrode is placed on the affected hemisphere

cathodal transcranial direct current stimulation

Device

The active electrode is placed on the unaffected hemisphere

Bilateral transcranial direct current stimulation

Device

The cathode and anode is positioned as active electrodes on the unaffected and affected hemisphere,respectively.

Sham Transcranial Direct Current Stimulation

Device

Placebo stimulation, with emission current by only 30 seconds

Primary outcomes

  1. Four Square Step Test

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

Secondary outcomes

  1. Occurrence of Falling Index

    Time frame: Baseline, Week 2, Week 4 and Week 12

  2. Overall Stability Index

    Time frame: Baseline, Week 2, Week 4 and Week 12

  3. Falls Efficacy Scale - International

    Time frame: Baseline, Week 2, Week 4 and Week 12

  4. Berg Balance Scale

    Time frame: Baseline, Week 2, Week 4 and Week 12

  5. Six-minute walk test

    Time frame: Baseline, Week 2, Week 4 and Week 12

  6. Sit to Stand Test

    Time frame: Baseline, Week 2, Week 4 and Week 12

Sponsors and collaborators

Lead sponsor

Federal University of Paraíba

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Apr 21, 2015
Registry last updated
Apr 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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