Ang 2012.
Methods | Study design: RCT Number of dropouts: none Number of adverse effects: none (Ang 2015 [pers comm]) Deaths: none ITT: yes |
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Participants | Country: Singapore Sample size: 19 participants; mean age (SD) 54 (10) years; mean UE‐FM (SD) 34 (8) Inclusion criteria: not explicitly stated Exclusion criteria: history of seizures; major depression; implants that interfered with tDCS; being able to operate an EEG‐based motor imagery brain‐computer interface (MI‐BCI); further therapy aiming at improving function in the affected upper limb |
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Interventions | 2 arms:
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Outcomes | Outcomes were measured at baseline, at the end of intervention period at 2 weeks and at 2 week follow‐up:
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | People were randomised by "A randomization stratification generated using a computer‐generated random sequence" (Ang 2015 [pers comm]) |
Allocation concealment (selection bias) | Unclear risk | Quote: "Interventions of the subjects were applied by an engineer and a research assistant respectively. For tDCS, the research assistant was the only person who knew the randomization sequence for the subjects allocation" (Ang 2015 [pers comm]) |
Blinding of participants and personnel (performance bias) Subjective outcome measures | Low risk | There were no subjective outcome measures |
Blinding of participants and personnel (performance bias) Objective outcome measures | Low risk | Participants were blinded; personnel were not blinded (Ang 2015 [pers comm]) |
Blinding of outcome assessment (detection bias) Subjective outcome measures | Low risk | There were no subjective outcome measures |
Blinding of outcome assessment (detection bias) Objective outcome measures | Low risk | Quote: "Yes, the outcome assessors for Fugl‐Meyer were blinded to group allocation" (Ang 2015 [pers comm]) |
Incomplete outcome data (attrition bias) Subjective outcome measures | Low risk | There were no subjective outcome measures |
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 | Not all of the secondary outcome measures listed in the published trial protocol have been reported, but will be presented in further publications (RMT of affected M1; grip strength; BBT; MRI parameters) |