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

Primary Purpose

Stroke

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Anodal transcranial direct current stimulation
Cathodal transcranial direct current stimulation
Bilateral transcranial direct current stimulation
Sham transcranial direct current stimulation
Sponsored by
Federal University of Paraíba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Severe functional limitations
  • Cognitive impairment

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Sham Comparator

    Arm Label

    Anodal tDCS

    Cathodal tDCS

    Bilateral tDCS

    Sham tDCS

    Arm Description

    Participants in the acute post-stroke stage will receive anodal transcranial direct current stimulation

    Participants in the acute post-stroke stage will receive cathodal transcranial direct current stimulation

    Participants in the acute post-stroke stage will receive bilateral transcranial direct current stimulation

    Participants in the acute post-stroke stage will receive sham transcranial direct current stimulation

    Outcomes

    Primary Outcome Measures

    Four Square Step Test

    Secondary Outcome Measures

    Occurrence of Falling Index
    Overall Stability Index
    Falls Efficacy Scale - International
    Berg Balance Scale
    Six-minute walk test
    Sit to Stand Test

    Full Information

    First Posted
    April 14, 2015
    Last Updated
    April 16, 2015
    Sponsor
    Federal University of Paraíba
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02422173
    Brief Title
    Transcranial Direct Current Stimulation on the Risk of Falls and Lower Limb Function for Acute Stroke
    Official 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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2015 (undefined)
    Primary Completion Date
    March 2015 (Actual)
    Study Completion Date
    April 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Federal University of Paraíba

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Anodal tDCS
    Arm Type
    Experimental
    Arm Description
    Participants in the acute post-stroke stage will receive anodal transcranial direct current stimulation
    Arm Title
    Cathodal tDCS
    Arm Type
    Experimental
    Arm Description
    Participants in the acute post-stroke stage will receive cathodal transcranial direct current stimulation
    Arm Title
    Bilateral tDCS
    Arm Type
    Experimental
    Arm Description
    Participants in the acute post-stroke stage will receive bilateral transcranial direct current stimulation
    Arm Title
    Sham tDCS
    Arm Type
    Sham Comparator
    Arm Description
    Participants in the acute post-stroke stage will receive sham transcranial direct current stimulation
    Intervention Type
    Device
    Intervention Name(s)
    Anodal transcranial direct current stimulation
    Intervention Description
    The active electrode is placed on the affected hemisphere
    Intervention Type
    Device
    Intervention Name(s)
    Cathodal transcranial direct current stimulation
    Intervention Description
    The active electrode is placed on the unaffected hemisphere
    Intervention Type
    Device
    Intervention Name(s)
    Bilateral transcranial direct current stimulation
    Intervention Description
    The cathode and anode is positioned as active electrodes on the unaffected and affected hemisphere,respectively.
    Intervention Type
    Device
    Intervention Name(s)
    Sham transcranial direct current stimulation
    Intervention Description
    Placebo stimulation, with emission current by only 30 seconds
    Primary Outcome Measure Information:
    Title
    Four Square Step Test
    Time Frame
    Change from Baseline in Risk of Falls at 3 months
    Secondary Outcome Measure Information:
    Title
    Occurrence of Falling Index
    Time Frame
    Baseline, Week 2, Week 4 and Week 12
    Title
    Overall Stability Index
    Time Frame
    Baseline, Week 2, Week 4 and Week 12
    Title
    Falls Efficacy Scale - International
    Time Frame
    Baseline, Week 2, Week 4 and Week 12
    Title
    Berg Balance Scale
    Time Frame
    Baseline, Week 2, Week 4 and Week 12
    Title
    Six-minute walk test
    Time Frame
    Baseline, Week 2, Week 4 and Week 12
    Title
    Sit to Stand Test
    Time Frame
    Baseline, Week 2, Week 4 and Week 12

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    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

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    33175411
    Citation
    Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. Cochrane Database Syst Rev. 2020 Nov 11;11(11):CD009645. doi: 10.1002/14651858.CD009645.pub4.
    Results Reference
    derived

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

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