Rossi 2013.
| Methods | Study design: single‐centre, randomised, double‐blind, sham‐controlled trial Dropouts: none Adverse effects: none Deaths: none ITT: yes, all participants completed the study |
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| Participants | Country: Italy Number of participants: 50 Inclusion criteria: age between 18 and 80 years and an acute ischaemic lesion in the territory of the MCA, a score between 6 and 20 at the NIHSS and a UE‐FM score between 15 and 55 Exclusion criteria: pre stroke mRS > 1, thrombolysis, history of seizure, advanced systemic diseases coexistent neurological/psychiatric diseases, current treatment with antidepressants, antipsychotics or benzodiazepines Age: (mean ± SD) tDCS‐group: 66.1 (± 14.3); sham group: 70.3 (± 13.5) years Gender: tDCS group: 12 male (48%), sham group: 14 male (56%) Time poststroke: 2 days Severity according NIHSS at baseline: tDCS‐group: 15.4 (± 4.9); sham group: 14.1 (± 3.5) |
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| Interventions | Number of arms: 2; each participant underwent 1 of the following conditions
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| Outcomes | Primary outcomes: UE‐FM at baseline, at the end of intervention and at 3 month follow‐up Secondary outcomes: NIHSS at baseline, at the end of intervention and at 3 month follow‐up; mRS at baseline, at the end of intervention and at 3‐month follow‐up | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Randomisation scheme was generated by a computer program (Koch 2013 [pers comm]) |
| Allocation concealment (selection bias) | Unclear risk | Allocation was performed by a third person via telephone (Koch 2013 [pers comm]) |
| Blinding of participants and personnel (performance bias) Subjective outcome measures | Low risk | Personnel were blinded to the type of treatment (Koch 2013 [pers comm]) |
| Blinding of participants and personnel (performance bias) Objective outcome measures | Low risk | Personnel were blinded to the type of treatment (Koch 2013 [pers comm]) |
| Blinding of outcome assessment (detection bias) Subjective outcome measures | Low risk | Evaluators were blinded (Koch 2013 [pers comm]) |
| Blinding of outcome assessment (detection bias) Objective outcome measures | Low risk | Evaluators were blinded (Koch 2013 [pers comm]) |
| Incomplete outcome data (attrition bias) Subjective outcome measures | Low risk | All participants completed the study. No treatment withdrawals, no losses to follow‐up, no trial group changes and no major adverse events were stated |
| Incomplete outcome data (attrition bias) Objective outcome measures | Low risk | All participants completed the study. No treatment withdrawals, no losses to follow‐up, no trial group changes and no major adverse events were stated |
| Selective reporting (reporting bias) | Low risk | All outcomes were stated as mentioned in preceding conference papers |