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

Tedesco Triccas 2015b.

Methods Study design: RCT
Number of dropouts: 1 in the A‐tDCS group (skin reaction due to tDCS)
Number of adverse effects: 1 in the A‐tDCS group (skin reaction due to tDCS)
Deaths: none
ITT: no
Participants Country: UK
Sample size: 22 participants
Inclusion criteria: aged 18 and above; clinical diagnosis of first‐ever stroke, confirmed by a neurologist/stroke specialist; time since stroke > 2 weeks prior to enrolment; upper and fore‐arm and hand paresis (MRC > 2); minimal spasticity (MAS ≤ 2); partial shoulder flexion with gravity; good sitting balance; informed consent
Exclusion criteria: MMSE < 24; other neurological conditions; shoulder pain resulting from shoulder flexion > 90°; epilepsy; metal implants in the skull or brain; previous brain neurosurgery; medications that influence cortical excitability; previous adverse effects when stimulated with tDCS; pregnancy
Interventions 2 arms
  1. A‐tDCS over M1 of the affected hemisphere (1 mA for 20 minutes) during the first 20 minutes of a 60 minute robotic training session with the ArmeoSpring device for 18 sessions during 8 weeks (approximately 2 to 3 sessions per week)

  2. Sham tDCS over M1 of the affected hemisphere (1 mA for 20 minutes) during the first 20 minutes of a 60 minute robotic training session with the ArmeoSpring device for 18 sessions during 8 weeks (approximately 2 to 3 sessions per week)

Outcomes Outcomes were measured at baseline and at the end of intervention and at 3 months follow‐up
Primary outcomes:
  1. UE‐FM


Secondary outcomes:
  1. ARAT

  2. MAL

  3. SIS 3.0

Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Block randomisation was used with a computer program called 'random allocation software'"
Allocation concealment (selection bias) Low risk Quote: "To conceal allocation, an independent person placed the printed papers of sham/real in sealed opaque envelopes according to block randomisation. As soon as a participant enrolled in the study, the researcher made a telephone call to the independent person who then stated whether ‘real’ or ‘sham’ was to be administered to the participant"
Blinding of participants and personnel (performance bias) 
 Subjective outcome measures Unclear risk Participants apparently were blinded, but blinding of personnel not stated
Blinding of participants and personnel (performance bias) 
 Objective outcome measures Low risk Participants apparently were blinded, but blinding of personnel not stated
Blinding of outcome assessment (detection bias) 
 Subjective outcome measures Low risk Quote: "Three blinded assessors, trained qualified physiotherapists with experience in stroke assessment and neurological rehabilitation carried out clinical assessments. In addition to the clinical assessor, video recorded FMA and ARAT assessments were also scored by an additional blinded clinical assessor"
Blinding of outcome assessment (detection bias) 
 Objective outcome measures Low risk Quote: "Three blinded assessors, trained qualified physiotherapists with experience in stroke assessment and neurological rehabilitation carried out clinical assessments. In addition to the clinical assessor, video recorded FMA and ARAT assessments were also scored by an additional blinded clinical assessor"
Incomplete outcome data (attrition bias) 
 Subjective outcome measures Unclear risk 1 participant in the A‐tDCS group dropped out (1 out of 23; 4%) because of a skin reaction due to tDCS, whereas in the sham group there were no dropouts. Quote: "After four intervention sessions, a participant with chronic stroke dropped out of the trial due to a skin reaction after receiving four real tDCS sessions"
Incomplete outcome data (attrition bias) 
 Objective outcome measures Unclear risk 1 participant in the A‐tDCS group dropped out (1 out of 23; 4 %) because of a skin reaction due to tDCS, whereas in the sham group there were no dropouts. Quote: "After four intervention sessions, a participant with chronic stroke dropped out of the trial due to a skin reaction after receiving four real tDCS sessions"
Selective reporting (reporting bias) Unclear risk All outcome measures listed in the methods section have been reported. All outcome measures from the published study protocol have been reported, except measures of cortical excitability