Fregni 2005a.
Methods | Study design: randomised double‐blind sham‐controlled cross‐over trial Dropouts: none Adverse effects: none Deaths: none ITT: yes |
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Participants | Country: not clearly stated Number of participants: 6 participants with chronic stroke neuroimaging‐proofed diagnosis; all were right‐handed and all had their strokes at least 12 months before the study Age: (mean ± SD) 53.7 ± 16.6 years Gender: 4 women (66%) Type of stroke: not stated Time poststroke: 27.1 months (range 12 to 72 months) Severity: motor strength (mean ± SD) 4.18 ± 0.37; ASS (mean ± SD) 0.83 ± 0.75 Inclusion criteria: not clearly stated Exclusion criteria: not clearly stated, but the authors referred to Hummel 2005, where the exclusion criteria were as follows: severe depression, history of severe alcohol or drug abuse, severe language disturbances, particularly of a receptive nature, or serious cognitive deficits (MMSE < 23/30 points) |
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Interventions | Characteristics: each participant underwent 3 different conditions for 20 minutes, separated by at least 48 hours of rest
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Outcomes | Outcomes used: duration of JTT in seconds Time point of measurement: at baseline after familiarisation session, during stimulation and directly after stimulation |
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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 |
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; blinding of personnel was not described |
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 | Outcome assessor was blinded; quote: "A blinded neuropsychologist—instructed not to communicate with the patient during the task—evaluated patients’ performance" |
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 | All outcomes reported in the methods section reported |