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

Completed

Phase 2/3 Results N/A

Trial Description

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.

Conditions

Interventions

  • Anodal transcranial direct current stimulation Device
    Other Names: (A-tDCS)
    Intervention Desc: The active electrode is placed on the affected hemisphere
    ARM 1: Kind: Experimental
    Label: Anodal tDCS
    Description: Participants in the acute post-stroke stage will receive anodal transcranial direct current stimulation
  • Cathodal transcranial direct current stimulation Device
    Other Names: tDCS
    Intervention Desc: The active electrode is placed on the unaffected hemisphere
    ARM 1: Kind: Experimental
    Label: Cathodal tDCS
    Description: Participants in the acute post-stroke stage will receive cathodal transcranial direct current stimulation
  • Sham transcranial Direct Current Stimulation Device
    Other Names: Sham
    Intervention Desc: Placebo stimulation, with emission current by only 30 seconds
    ARM 1: Kind: Experimental
    Label: Sham tDCS
    Description: Participants in the acute post-stroke stage will receive sham transcranial direct current stimulation
  • Bilateral transcranial direct current stimulation Device
    Intervention Desc: The cathode and anode is positioned as active electrodes on the unaffected and affected hemisphere,respectively.
    ARM 1: Kind: Experimental
    Label: Bilateral tDCS
    Description: Participants in the acute post-stroke stage will receive bilateral transcranial direct current stimulation

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Four Square Step Test Change from Baseline in Risk of Falls at 3 months No
Secondary Occurrence of Falling Index Baseline, Week 2, Week 4 and Week 12 No
Secondary Overall Stability Index Baseline, Week 2, Week 4 and Week 12 No
Secondary Falls Efficacy Scale - International Baseline, Week 2, Week 4 and Week 12 No
Secondary Berg Balance Scale Baseline, Week 2, Week 4 and Week 12 No
Secondary Six-minute walk test Baseline, Week 2, Week 4 and Week 12 No
Secondary Sit to Stand Test Baseline, Week 2, Week 4 and Week 12 No

Sponsors