Bolognini 2011.
Methods | Study design: randomised controlled multicentre trial Dropouts: 7 Adverse effects: none Deaths: not stated ITT: no |
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Participants | Country: not stated Number of participants: 14 participants from the outpatient population of 3 neurological research units Age: (mean ± SD) 46.71 ± 14.08 years Gender: 9 female (64%) Type of stroke: 2 haemorrhagic (14%) Time poststroke: (mean ± SD) 35.21 ± 26.45 months Severity: moderate to severe hemiparesis, as indexed by UE‐FM (mean score 26, range 8 to 50) Inclusion criteria: ischaemic or haemorrhagic first‐ever stroke, stroke onset > 6 months before the study, functional inclusion criteria as defined by the EXCITE trial Exclusion criteria: pre stroke motor impairment affecting the upper limbs, moderate to severe major depression, previous CIMT and/or tDCS and contraindications regarding CIMT and/or tDCS |
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Interventions | Number of arms: 2
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Outcomes | Outcomes used:
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated randomisation list (Bolognini 2013 [pers comm]) |
Allocation concealment (selection bias) | Unclear risk | The principal investigator, who took no part in data collection, nor in participants' evaluations, nor in treatment, knew the randomisation list and performed allocation (Bolognini 2013 [pers comm]) |
Blinding of participants and personnel (performance bias) Subjective outcome measures | Unclear risk | Participants were blinded; blinding of personnel was not described |
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 | Quote: "The assessment of motor functions and the administration of the functional scales and questionnaires were performed by a trained staff, blinded to group assignment" |
Blinding of outcome assessment (detection bias) Objective outcome measures | Low risk | Quote: "The assessment of motor functions and the administration of the functional scales and questionnaires were performed by a trained staff, blinded to group assignment" |
Incomplete outcome data (attrition bias) Subjective outcome measures | Low risk | Dropouts due to frustration and tiredness during assessment, quote: "Five patients (2 in the active group and 3 in the sham group) did not complete the JHFT. Two patients (1 in the active group and 1 in the sham group) did not complete the HS task." These participants have been excluded from analysis and presentation of results" |
Incomplete outcome data (attrition bias) Objective outcome measures | Unclear risk | Dropouts due to frustration and tiredness during assessment, quote: "Five patients (2 in the active group and 3 in the sham group) did not complete the JHFT. Two patients (1 in the active group and 1 in the sham group) did not complete the HS task." These participants have been excluded from analysis and presentation of results" |
Selective reporting (reporting bias) | Unclear risk | All outcomes reported in the methods section reported |