Fusco 2013a.
| Methods | Study design: double‐blinded, sham‐controlled, randomised cross‐over study Dropouts: none Adverse effects: none Deaths: none ITT: yes |
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| Participants | Country: Italy Number of participants: 9 Age (mean ± SD): 53.5 ± 20.7 years Gender: 4 (57%) female Type of stroke: 8 (89%) ischaemic, 1 (11%) haemorrhagic Time poststroke (mean ± SD): 28.3 ± 10.4 days Severity (mean ± SD): grip strength 17.83 ± 7.45 kg Inclusion criteria: cortical or subcortical first‐ever stroke (radiologically confirmed), possibility to perform pinch/grip test Exclusion criteria: history of chronic disabling pathologies of the upper limb; spasticity; presence of pacemaker or severe cardiovascular conditions; a history of tumour, prior neurosurgical brain intervention, severe cardiovascular conditions (including the presence of a pacemaker), a diagnosis of epilepsy or major psychiatric disorders |
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| Interventions | Each participant underwent 1 of the following different stimulation conditions in 2 consecutive sessions on 2 consecutive days in random order (sham tDCS was obligatory)
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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: "For the random sequence generation, we used the RAND function in Matlab" |
| Allocation concealment (selection bias) | Low risk | Quote: "Specifically, patients were asked to take a sealed envelope from a box, containing a piece of paper with the assignment, which was concealed until the envelope was opened" |
| Blinding of participants and personnel (performance bias) Subjective outcome measures | Unclear risk | Quote: "Patients were blinded while physicians and assessors knew the treatment (real or sham)" |
| Blinding of participants and personnel (performance bias) Objective outcome measures | Low risk | Quote: "Patients were blinded while physicians and assessors knew the treatment (real or sham)" |
| Blinding of outcome assessment (detection bias) Subjective outcome measures | High risk | Quote: "Patients were blinded while physicians and assessors knew the treatment (real or sham)" |
| Blinding of outcome assessment (detection bias) Objective outcome measures | Unclear risk | Quote: "Patients were blinded while physicians and assessors knew the treatment (real or sham)" |
| 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) | Unclear risk | All outcomes reported in the methods section reported |