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 |
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| 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 |
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| Interventions | 2 arms
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| Outcomes | Outcomes were measured at baseline and at the end of intervention and at 3 months follow‐up Primary outcomes:
Secondary outcomes:
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| 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 |