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

Nair 2011.

Methods Study design: randomised double‐blind sham‐controlled trial
Dropouts: none
Adverse effects: none
Deaths: none
ITT: yes
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
Interventions Number of arms: 2 participants underwent occupational therapy + 1 of the following conditions
  1. C‐tDCS over M1 of the non‐lesioned hemisphere (1 mA for 30 minutes)

  2. Sham tDCS over M1 of the non‐lesioned hemisphere (for 30 minutes)

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
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)