Nair 2011.
Methods | Study design: randomised double‐blind sham‐controlled trial Dropouts: none Adverse effects: none Deaths: none ITT: yes |
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Participants | Country: USA Number of participants: 14 right‐handed Age: (mean) 55.8, range of 40 to 76 years Gender: 5 female (36%) Type of stroke: first‐ever unihemispheric stroke, 6 (43%) had right‐hemispheric stroke, 9 (64%) had predominantly cortical stroke, 5 (36%) had predominantly subcortical stroke Time poststroke: (mean ± SD) Severity: moderate to severe upper extremity impairment, UE‐FM (mean ± SD) 30.1 ± 10.4 Inclusion criteria: not clearly stated Exclusion criteria: previous history of stroke, bilateral infarcts, haemorrhage, arthritis, chronic pain, other neurological diseases |
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Interventions | Number of arms: 2 participants underwent occupational therapy + 1 of the following conditions
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Outcomes | Primary outcomes: mean ROM for shoulder abduction, elbow extension and wrist extension (3J‐ROM; calculated as active ROM∗100/passive ROM for each joint, 0 to 100, with higher values indicating better function) and proportional change in UE‐FM (0 to 66, with higher scores indicating better motor performance) Time point of measurement: at baseline, after the intervention and at 1‐week follow‐up |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not described |
Allocation concealment (selection bias) | Unclear risk | Not described, quote: "Patients were randomised to either the cathodal group or the sham group" |
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 and personnel were blinded |
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: "The 3J‐ROM and the FM assessments were done by an investigator who was blind with regard to whether real tDCS or sham tDCS was applied" |
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 randomised 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) | High risk | Results of Wolf Motor Function Test, Modified Ashworth Scale and Motor Activity Log Rating Scale were not reported, as intended by the protocol (http://ClinicalTrials.gov/show/NCT00792428) |