Transcranial Direct Current Stimulation on the Risk of Falls and Lower Limb Function for Acute Stroke
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
1 other identifier
interventional
60
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 stroke
Started Jan 2015
Shorter than P25 for phase_2 stroke
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 14, 2015
CompletedFirst Posted
Study publicly available on registry
April 21, 2015
CompletedApril 21, 2015
April 1, 2015
2 months
April 14, 2015
April 16, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Four Square Step Test
Change from Baseline in Risk of Falls at 3 months
Secondary Outcomes (6)
Occurrence of Falling Index
Baseline, Week 2, Week 4 and Week 12
Overall Stability Index
Baseline, Week 2, Week 4 and Week 12
Falls Efficacy Scale - International
Baseline, Week 2, Week 4 and Week 12
Berg Balance Scale
Baseline, Week 2, Week 4 and Week 12
Six-minute walk test
Baseline, Week 2, Week 4 and Week 12
- +1 more secondary outcomes
Study Arms (4)
Anodal tDCS
EXPERIMENTALParticipants in the acute post-stroke stage will receive anodal transcranial direct current stimulation
Cathodal tDCS
EXPERIMENTALParticipants in the acute post-stroke stage will receive cathodal transcranial direct current stimulation
Bilateral tDCS
EXPERIMENTALParticipants in the acute post-stroke stage will receive bilateral transcranial direct current stimulation
Sham tDCS
SHAM COMPARATORParticipants in the acute post-stroke stage will receive sham transcranial direct current stimulation
Interventions
The active electrode is placed on the affected hemisphere
The active electrode is placed on the unaffected hemisphere
The cathode and anode is positioned as active electrodes on the unaffected and affected hemisphere,respectively.
Placebo stimulation, with emission current by only 30 seconds
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of acute stroke
- Able to walk 10m independently
- High risk of falling
You may not qualify if:
- Severe functional limitations
- Cognitive impairment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 33175411DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, PhD
Study Record Dates
First Submitted
April 14, 2015
First Posted
April 21, 2015
Study Start
January 1, 2015
Primary Completion
March 1, 2015
Study Completion
April 1, 2015
Last Updated
April 21, 2015
Record last verified: 2015-04