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

Lee 2014.

Methods Method: RCT
Number of dropouts: 5 (3 out of 42 in the experimental groups (7%) and 2 out of 22 in the control group (9%))
Number of adverse effects: no major adverse events
Deaths: none
ITT: no
Participants Country: Republic of Korea
Sample size: 59 people with stroke (39 in the experimental groups and 20 in the control group)
Inclusion criteria: unilateral hemiparesis caused by stroke; first stroke within 1 month prior to enrolment; shoulder motor strength Medical Research Council grade ≤ 2
Exclusion criteria: contraindications to brain stimulation; previous history of brain neurosurgery or epilepsy; metallic implants in the brain; severe cognitive impairment; aphasia interfering with understanding study instructions; poor sitting balance; impaired vision; hemispatial neglect
Interventions 3 arms
  1. C‐tDCS over the hand area of M1 over the non‐lesioned hemisphere (2 mA for 20 minutes) during occupational therapy aiming at functional improvement of the affected arm for 30 minutes per day, 5 times a week for 3 weeks;

  2. Virtual reality training aiming at functional improvement of the affected arm for 30 minutes per day, 5 times a week for 3 weeks;

  3. C‐tDCS plus virtual reality training aiming at functional improvement of the affected arm for 30 minutes per day, 5 times a week for 3 weeks

Outcomes Outcomes were measured at baseline and at the end of intervention period
  1. Modified Ashworth Scale

  2. Manual Muscle Testing

  3. Manual Function Test

  4. Fugl‐Meyer assessment, upper extremity subscale

  5. Korean‐Modified Barthel Index

Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "All of the enrolled patients were randomly assigned to 1 of 3 groups using a table of random numbers"
Allocation concealment (selection bias) Unclear risk Not described by the authors
Blinding of participants and personnel (performance bias) 
 Subjective outcome measures Low risk Participants and personnel providing the base treatment were blinded
Blinding of participants and personnel (performance bias) 
 Objective outcome measures Low risk Participants and personnel providing the base treatment were blinded
Blinding of outcome assessment (detection bias) 
 Subjective outcome measures Low risk Quote: "All evaluations were performed before and immediately after treatment by a single experienced occupational therapist who was not aware of the treatment allocation"
Blinding of outcome assessment (detection bias) 
 Objective outcome measures Low risk Quote: "All evaluations were performed before and immediately after treatment by a single experienced occupational therapist who was not aware of the treatment allocation"
Incomplete outcome data (attrition bias) 
 Subjective outcome measures High risk 3 participants out of 42 (7%) in the experimental groups and 2 out of 22 (9%) were lost to follow‐up and excluded from the analysis. 2 out of the 3 losses to follow‐up in the experimental group dropped out due to "medical problem(s)"
Incomplete outcome data (attrition bias) 
 Objective outcome measures High risk 3 participants out of 42 (7%) in the experimental groups and 2 out of 22 (9%) were lost to follow‐up and excluded from the analysis. 2 out of the 3 losses to follow‐up in the experimental group dropped out due to "medical problem(s)"
Selective reporting (reporting bias) Unclear risk All outcomes listed in the methods section reported