| Trial name or title |
A double‐blind, sham‐controlled, randomised clinical trial on stroke treatment using transcranial direct current stimulation |
| Methods |
RCT with parallel‐group design |
| Participants |
Estimated enrolment: 40
Inclusion criteria: aged between 18 and 65 years; acute ischaemic stroke; informed consent
Exclusion criteria: NIHSS between 25 and 32; Rankin ≥ 5; MMSE ≤ 24; use of drugs changing CNS excitability; metallic implants; seizures; pregnancy; other conditions interfering with CIMT criteria; inability to voluntarily execute wrist flexion, 10° of finger extension and 20° of wrist extension |
| Interventions |
2 arms
Active tDCS plus CIMT daily for 10 consecutive working days Sham tDCS plus CIMT daily for 10 consecutive working days
|
| Outcomes |
Primary outcome measure
BI (at 4 months)
Secondary outcome measures
MoCA (at baseline and at the end of intervention period) Victoria version of the Stroop Color and Word Test (at baseline and at the end of intervention period) Digit span test (at baseline and at the end of intervention period) Spasticity (at baseline and at the end of intervention period) Muscle strength (at baseline and at the end of intervention period) Balance (at baseline and at the end of intervention period) Posture (at baseline and at the end of intervention period) Fear of falling during daily life activities (at baseline and at the end of intervention period) Upper limb function (at baseline and at the end of intervention period) Quality of Life (at baseline and at the end of intervention period) Lower limb function (at baseline and at the end of intervention period)
|
| Starting date |
June 2014 |
| Contact information |
Suellen Marinho Andrade, MSc
Federal University of Paraíba, Department of Psychology
João Pessoa, Paraíba, Brazil, 58051‐900 |
| Notes |
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