Hesse 2011.
| Methods | Study design: double‐blind randomised sham‐controlled multicentre trial Dropouts: 11 (11%) Adverse effects: none Deaths: 2 (2%) due to heart infarction and during stent surgery ITT: yes, 85 participants completed the study (89%) |
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| Participants | Country: Germany/Italy Number of participants: 96 stroke participants from 3 study centres Mean age: 65.0, range 39 to 79 years Gender: 37 female (39%) Type of stroke: all ischaemic, 45 of 96 (47%) right‐hemispheric stroke Time poststroke: (mean ± SD) A‐tDCS group: 3.4 ± 1.8 weeks; C‐tDCS group: 3.8 ± 1.4 weeks; sham tDCS group: 3.8 ± 1.5 weeks Severity: at least wheelchair‐mobile participants, who had severe flaccid upper limb paresis with no (MRC 0) or minimal (MRC 1) volitional hand and finger extensor activity. 24 had an upper limb UE‐FM (range 0 to 66) < 18 and were unable to transfer 3 wooden blocks from 1 compartment to the other in the Box and Block test Inclusion criteria: age 18 to 79 years, first supratentorial ischaemic stroke with a stroke interval of 3 to 8 weeks' duration, and with participation in a comprehensive inpatient rehabilitation programme Exclusion criteria: history of epileptic seizures, EEG suspect of elevated cortical excitability, metallic implants in the brain, preceding brain surgery, sensitive scalp skin, anticonvulsant or neuroleptic medications |
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| Interventions | Number of arms: 3; each participant practiced for 6 weeks every working day for 20 minutes with the arm robot (AT) and simultaneously received one of the following interventions:
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| Outcomes | Primary outcome: sensory and motor integrity, degree of synergy as assessed by UE‐FM assessment score (0 to 66, 0 = no movement, 66 = full motion) Secondary outcomes: upper limb muscle strength (MRC; 0 to 5, 0 = plegic, 5 = full power), muscle tone (MAS; 0 to 5, 0 = no increase, 5 = affected part rigid in flexion or extension), BI, upper limb function (as assessed by Box and Block test, the transfer of as many wooden blocks as possible with the affected hand from 1 compartment to the other within 1 minute, with a high value indicating good function) Time point of measurement: study onset, end of the 6‐week intervention and 3 months of follow‐up |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "Following a telephone call, an independent person randomly allocated eligible patients to 1 of the 3 groups by drawing a lot out of an envelope containing 96 lots, indicating A, B, and C" |
| Allocation concealment (selection bias) | Low risk | Quote: "Following a telephone call, an independent person randomly allocated eligible patients to 1 of the 3 groups by drawing a lot out of an envelope containing 96 lots, indicating A, B, and C. He then informed the locally responsible person about the group assignment and the study started the next day" |
| Blinding of participants and personnel (performance bias) Subjective outcome measures | Low risk | Participants and personnel were blinded |
| 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 | Quote: "To ensure blinded evaluation of the FMS, videos of the assessment, where the patients sat on a chair and a mirror was placed 45° behind them, were sent to an experienced therapist off site" and "Two experienced physiotherapists, blinded with respect to group assignment, assessed the secondary parameters together" and "The blinding was maintained at all measurement points" |
| Blinding of outcome assessment (detection bias) Objective outcome measures | Low risk | Quote: "To ensure blinded evaluation of the FMS, videos of the assessment, where the patients sat on a chair and a mirror was placed 45° behind them, were sent to an experienced therapist off site" and "Two experienced physiotherapists, blinded with respect to group assignment, assessed the secondary parameters together" and "The blinding was maintained at all measurement points" |
| Incomplete outcome data (attrition bias) Subjective outcome measures | Low risk | 1 dropout occurred during the study period as the result of pneumonia, and 10 after the end of the intervention period until follow‐up (6 were caused by being unavailable, 2 resulted from refusal to further participate and 2 were caused by cardiac conditions). ITT analysis was performed |
| Incomplete outcome data (attrition bias) Objective outcome measures | Low risk | 1 dropout occurred during the study period as the result of pneumonia, and 10 after the end of the intervention period until follow‐up (6 were caused by being unavailable, 2 resulted from refusal to further participate and 2 were caused by cardiac conditions). ITT analysis was performed |
| Selective reporting (reporting bias) | Low risk | All outcomes reported in the methods section and in the published trial protocol reported |