Stroke
Conditions
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.
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.
DEVICESham transcranial direct current stimulation
Placebo stimulation, with emission current by only 30 seconds
Sponsors
Federal University of Paraíba
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of acute stroke * Able to walk 10m independently * High risk of falling
Exclusion criteria
* Severe functional limitations * Cognitive impairment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Four Square Step Test | Change from Baseline in Risk of Falls at 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Overall Stability Index | Baseline, Week 2, Week 4 and Week 12 |
| Falls Efficacy Scale - International | Baseline, Week 2, Week 4 and Week 12 |
| Occurrence of Falling Index | Baseline, Week 2, Week 4 and Week 12 |
| Six-minute walk test | Baseline, Week 2, Week 4 and Week 12 |
| Sit to Stand Test | Baseline, Week 2, Week 4 and Week 12 |
| Berg Balance Scale | Baseline, Week 2, Week 4 and Week 12 |
Outcome results
None listed