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
About this trial
This is an interventional treatment trial for Stroke
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
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
NCT ID
NCT02422173
First Posted
April 14, 2015
Last Updated
April 16, 2015
Sponsor
Federal University of Paraíba
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
Learn more about this trial
Transcranial Direct Current Stimulation on the Risk of Falls and Lower Limb Function for Acute Stroke
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