Kim 2010.
Methods | Study design: double‐blind sham‐controlled multicentre randomised trial Dropouts: 1 participant discontinued treatment because of dizziness and another because of headache (2 out of 20) during follow‐up Adverse effects: none Deaths: none ITT: no |
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Participants | Country: Republic of Korea Number of participants: 20 participants from neurorehabilitation units at 2 tertiary university hospitals Age: (mean ± SD) 57.27 ± 4.95 Gender: 7 female (35%) Type of stroke: first‐ever cortical or subcortical ischaemic stroke Time poststroke: (mean ± SD) A‐tDCS group: 34 ± 27.1 days; C‐tDCS: 19.4 ± 9.3 days; sham tDCS: 22.9 ± 7.5 days Severity: mild to moderate motor deficits (MRC score ≥ 2) Inclusion criteria: first‐ever ischaemic strokes in the cortical or subcortical area within the previous 2 months and mild to moderate motor deficits (MRC score ≥ 2) Exclusion criteria: cerebellar or brainstem lesions; presence of a metallic foreign body implant, such as a pacemaker or an artificial cochlea; history of seizure or another unstable medical condition; severe language disturbance; neglect, depression or cognitive deficits (based on the MMSE, 10 of 30 points) that would limit participation; history of severe alcohol or drug abuse; previous stroke that resulted in residual disability; premorbid arm impairment; and hemiplegic shoulder pain; use Na+ or Ca2+channel blockers or NMDA receptor antagonists |
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Interventions | Number of arms: 3 Each participant received 10 sessions (5 times per week for 2 weeks during conventional occupational therapy aiming at improving the co‐ordination and strength of the paretic hand) of 1 of the following interventions:
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Outcomes | Outcomes used: FMA 0 to 66 (with higher scores indicating better function) for assessing upper limb motor function and MBI 0 to 100 (with higher scores indicating better global function) Time point of measurement: at baseline, 1 day and 6 months after intervention |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Patients were randomly assigned to one of the three groups (atDCS, ctDCS or Sham treatment) using a stratified randomisation procedure with permuted block size of 3 and an algorithm that balanced Brunnstrom stages" |
Allocation concealment (selection bias) | Low risk | Quote: "Sealed opaque envelopes were used for randomisation" |
Blinding of participants and personnel (performance bias) Subjective outcome measures | Low risk | Participants and personnel were blinded |
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 | Quote: "Two independent raters blinded to the type of intervention performed outcome measurements" |
Blinding of outcome assessment (detection bias) Objective outcome measures | Low risk | Quote: "Two independent raters blinded to the type of intervention performed outcome measurements" |
Incomplete outcome data (attrition bias) Subjective outcome measures | Unclear risk | 1 participant of each interventional arm (14% each) discontinued intervention; we excluded these participants from analysis |
Incomplete outcome data (attrition bias) Objective outcome measures | Unclear risk | 1 participant of each interventional arm (14% each) discontinued intervention; we excluded these participants from analysis |
Selective reporting (reporting bias) | Unclear risk | All outcomes reported in the methods section reported |