Di Lazzaro 2014a.
Methods | Study design: RCT Number of dropouts: none Number of adverse effects: not reported Deaths: none ITT: yes |
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Participants | Country: Italy Sample size: 14 (7 in the experimental and 7 in the control group) Inclusion criteria: first ischaemic cerebral infarction confirmed by MRI; admitted to Stroke Unit; aged between 18 to 90 years; acute phase of stroke Exclusion criteria: prestroke disability; not understanding instructions for motor testing; excessive pain in any joint of the paretic limbs; contraindications to single‐pulse TMS; advanced diseases of inner organs; concurrent neurologic or psychiatric diseases; history of substance abuse; use of neuropsychotropic drugs |
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Interventions | 2 arms
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Outcomes | Outcomes were measured at baseline and at the end of intervention period
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "patients were randomized to real or sham tDCS treatment through a block randomization stratification approach" |
Allocation concealment (selection bias) | Unclear risk | Not described by the authors |
Blinding of participants and personnel (performance bias) Subjective outcome measures | Low risk | Participants and personnel were blinded; quote "The investigators who applied real/sham tDCS were kept blind to the intervention by using the pre‐programmed stimulation mode in the stimulator settings" |
Blinding of participants and personnel (performance bias) Objective outcome measures | Low risk | Participants and personnel were blinded; quote "The investigators who applied real/sham tDCS were kept blind to the intervention by using the pre‐programmed stimulation mode in the stimulator settings" |
Blinding of outcome assessment (detection bias) Subjective outcome measures | Low risk | Quote: "An evaluator, blinded to the treatment, assessed the effects of the intervention" |
Blinding of outcome assessment (detection bias) Objective outcome measures | Low risk | Quote: "An evaluator, blinded to the treatment, assessed the effects of the intervention." |
Incomplete outcome data (attrition bias) Subjective outcome measures | Low risk | All participants apparently 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 apparently 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) | High risk | All outcomes listed in the methods section reported except 'Adverse events', which was not reported clearly |