Wu 2013a.
| Methods | Study design: RCT with parallel‐group design Dropouts: none Adverse effects: none Deaths: none ITT: yes Duration: 1 month |
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| Participants | Country: China Number of participants: 90 Age: mean (SD) C‐tDCS: 45.9 (11.2), sham tDCS 49.3 (12.6) years Gender: C‐tDCS: 34 (76%) male, sham tDCS: 35 (78%) male Type of stroke: C‐tDCS: 27 (60%) ischaemic, sham tDCS: 26 (58%) ischaemic Time poststroke in months: mean (SD) C‐tDCS: 4.9 (3.0); sham tDCS 4.9 (2.9) Severity: FMA for C‐tDCS: 12 (4 to 26) and 8 (3 to 34), BI for C‐tDCS 55 (0 to 85) and 55 (25 to 95) for sham tDCS Inclusion criteria: time since stroke > 2 months, first‐ever stroke, muscle tone at wrist and elbow with MAS score ≥ 1 and ≤ 3, no history of Botox or other invasive treatment in the previous 6 months, use of spasmolytics resulting in an adverse event or maximised dosing without effect and no severe cognitive or mood disorders Exclusion criteria: unstable vital signs or unstable, progressive or severe neurological disease, heart condition or hypertension |
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| Interventions | 2 arm
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| Outcomes | Outcomes used: MAS (range from 0 to 4, with a score of 4 reflecting the highest possible muscle tone), UE‐FM (0 to 66, with higher scores reflecting better motor performance) and MBI (0 to 105, with higher scores reflecting better ADL performance) Time points of measurement: at baseline, at the end of the intervention period and at 4‐week follow‐up |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "Subjects were randomly assigned using a computer‐generated randomisation list by a single investigator" |
| Allocation concealment (selection bias) | Low risk | Quote: "The assigned random number was inputted into the stimulator device by the same investigator. She did not participate in other parts of the study. The device automatically generated active or sham tDCS according to the parity of the random number" |
| Blinding of participants and personnel (performance bias) Subjective outcome measures | Low risk | Quote: "All other investigators, subjects, and outcome assessors remained blinded to group allocation until the completion of the final statistical analyses" |
| Blinding of participants and personnel (performance bias) Objective outcome measures | Low risk | Quote: "All other investigators, subjects, and outcome assessors remained blinded to group allocation until the completion of the final statistical analyses" |
| Blinding of outcome assessment (detection bias) Subjective outcome measures | Low risk | Quote: "All other investigators, subjects, and outcome assessors remained blinded to group allocation until the completion of the final statistical analyses" |
| Blinding of outcome assessment (detection bias) Objective outcome measures | Low risk | Quote: "All other investigators, subjects, and outcome assessors remained blinded to group allocation until the completion of the final statistical analyses" |
| 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 from the methods section and from the published trial protocol were reported |
A‐tDCS: anodal transcranial direct current stimulation AMT: active motor threshold ARAT: Action Research Arm Test ASS: Ashworth Spasticity Score AT: arm robotic training BBT: Box and Block Test BI: Barthel Index C‐tDCS: cathodal transcranial direct current stimulation CIMT: constraint‐induced movement therapy DLPFC: Dorsolateral prefrontal cortex EEG: electroencephalography ESS: European Stroke Scale FAC: Functional Ambulation Category FDI: first dorsal interosseous muscle FMA: Fugl‐Meyer Assessment iTBS: intermittent theta burst stimulation ITT: intention‐to‐treat analysis JTT: Jebsen Taylor Hand Function Test LTP: Long‐term potentiation M1: primary motor cortex mA: milliampere MAL: Motor Activity Log Rating Scale MAS: Modified Ashworth Scale MBI: Modified Barthel Index MCA: middle cerebral artery MEP: motor‐evoked response MI: Motricity Index MI‐BCI: motor imagery brain‐computer interface MIT: Massachusetts Institute of Technology MMSE: Mini Mental State Examination MP: methylphenidate MRC: Medical Research Council MRI: magnetic resonance imaging NIHSS: National Institute of Health Stroke Scale NMDA: N‐methyl‐D‐aspartate NRS: Numerical Rating Scale OMCASS: Orgogozo MCA scale PPC: posterior parietal cortex PPT: Purdue Pegboard Test RCT: randomised controlled trial ROM: range of motion RMI: Rivermead Mobility Index RMT: resting motor threshold SD: standard deviation SIS: Stroke Impact Scale tDCS: transcranial direct current stimulation TUG: Timed Up and Go Test UE‐FM: Upper Extremity Fugl‐Meyer Score WMFT: Wolf Motor Function Test