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

Fusco 2014.

Methods Method: RCT
Number of dropouts: 3 (2 (14%) in the experimental group, 1 (7%) in the control group)
Number of adverse effects: not reported
Deaths: not described
ITT: no
Participants Country: Italy
Sample size: 11 participants (5 in the experimental and 6 in the control group)
Inclusion criteria: admission to stroke unit; age between 18 and 83 years; ischaemic stroke in the MCA area confirmed by MRI or CT; time since stroke less than 30 days; no history of severe cognitive impairment; written informed consent
Exclusion criteria: inability to perform a motor rehabilitation training; haemorrhagic stroke or multiple foci of ischaemia; previous stroke; diagnosis of major psychiatric disorders; epilepsy; history of tumour; pacemaker; uncontrolled arrhythmias; non‐stabilised heart diseases; dementia or severe aphasia
Interventions 2 arms

  1. C‐tDCS (1.5 mA for 10 minutes) over M1 of the unaffected hemisphere on 5 consecutive days each week for 2 weeks prior to a rehabilitative session

  2. Sham tDCS (not described) over M1 of the unaffected hemisphere on 5 consecutive days each week for 2 weeks prior to a rehabilitative session
Outcomes Outcomes were measured at baseline, after the end of intervention period, 1 month after the intervention period and at the end of inpatient rehabilitation (75 to 110 days)

  1. Canadian Neurological Scale

  2. Barthel Index

  3. 9‐hole peg test

  4. Grasp and pinch force

  5. Upper extremity Fugl‐Meyer Assessment

  6. Timed Up and Go Test

  7. 6‐Minute Walking Test

  8. 10‐Meter Walking Test

  9. Rivermead Mobility Index

  10. Functional Ambulation Categories
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "The randomization was created in accordance with a binary sequence previously generated using MATLAB R2007b Software (TheMatworks Inc., USA)"
Allocation concealment (selection bias) Unclear risk Not described by the authors
Blinding of participants and personnel (performance bias) 
 Subjective outcome measures Unclear risk Quote: "The patient was blind to the type of stimulation. An unblinded investigator administered the stimulation"
Blinding of participants and personnel (performance bias) 
 Objective outcome measures Low risk Quote: "The patient was blind to the type of stimulation. An unblinded investigator administered the stimulation"
Blinding of outcome assessment (detection bias) 
 Subjective outcome measures Low risk Quote: "The patient was blind to the type of stimulation, as well as the physician performing the assessments"
Blinding of outcome assessment (detection bias) 
 Objective outcome measures Low risk Quote: "The patient was blind to the type of stimulation, as well as the physician performing the assessments"
Incomplete outcome data (attrition bias) 
 Subjective outcome measures High risk Quote: "Two patients of EG dropped out from the study (one at the first and the other one at the second session). Also one patient of control group dropped out for an emergency transfer to another hospital." These participants have not been analysed
Incomplete outcome data (attrition bias) 
 Objective outcome measures High risk Quote: "Two patients of EG dropped out from the study (one at the first and the other one at the second session). Also one patient of control group dropped out for an emergency transfer to another hospital." These participants have not been analysed
Selective reporting (reporting bias) Unclear risk All outcomes reported in the methods section reported