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. 2016 Mar 21;2016(3):CD009645. doi: 10.1002/14651858.CD009645.pub3

Bolognini 2011.

Methods Study design: randomised controlled multicentre trial
Dropouts: 7
Adverse effects: none
Deaths: not stated
ITT: no
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
Interventions Number of arms: 2
  1. 14‐day CIMT with shaping techniques + A‐tDCS (2 mA, 40 minutes) over the lesioned primary motor cortex (M1)

  2. 14‐day CIMT with shaping techniques + sham tDCS (40 minutes) over the lesioned primary motor cortex (M1)

Outcomes Outcomes used:
  1. Motor assessments: duration of JTT in seconds, handgrip strength, MAL, UE‐FM

  2. Visual analogue scales for anxiety and pain/discomfort, questionnaire for adverse effects

  3. Time point of measurement: day 1, day 5, day 10 (end of treatment) and at 2 and 4 weeks of follow‐up

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