Geroin 2011.
| Methods | Study design: pilot RCT Dropouts: none Adverse effects: none Deaths: none ITT: yes |
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| Participants | Country: Italy Number of participants: 30 outpatients Age: (mean ± SD) 62.7 ± 6.4 years Gender: 7 females (23%) Type of stroke: unilateral ischaemic stroke Time poststroke: (mean ± SD) 26.4 ± 5.5 months Severity: mean ESS score 79.93 (minimum score: 0, maximum score: 100; a completely healthy person would have a score of 100) Inclusion criteria: at least 12 months from first unilateral ischaemic stroke, age < 75 years, ESS score ≥ 75 and ≤ 85, MMSE‐score ≥ 24, ability to maintain standing position without aid for at least 5 minutes, ability to walk independently for at least 15 minutes with the use of walking aids Exclusion criteria: history of seizures, EEG suspect of elevated cortical excitability, metallic implants within the brain and previous brain neurosurgery, medications altering cortical excitability or with a presumed effect of brain plasticity, posterior circulation stroke, deficits of somatic sensations involving the paretic lower limb, presence of vestibular disorders/paroxysmal vertigo, severe cognitive or communicative disorders, cardiovascular comorbidity, rehabilitation treatment 3 months before study enrolment |
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| Interventions | Number of arms: 3; all participants underwent 50‐minute training sessions 5 times a week for 2 consecutive weeks and 1 of the following interventions
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| Outcomes | Primary outcomes: six‐minute walking test, 10‐metre walking test Secondary outcomes: GAITRite system, FAC, RMI, MI leg subscore and MAS Time point of measurement: at baseline, after treatment and at two weeks follow‐up |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "After baseline evaluation, patients were allocated to one of three treatment groups according to a simple software‐generated randomisation scheme" |
| Allocation concealment (selection bias) | Low risk | Quote: "We allocated patients to one of the three treatment arms according to a restricted randomisation scheme. One of the investigators checked correct patient allocation according to the randomisation list. After unmasking at the end of the study, we checked that no errors had been made in allocation" (Smania 2013 [pers comm]) |
| Blinding of participants and personnel (performance bias) Subjective outcome measures | Unclear risk | Quote: "Asking the assessor to make an educated guess tested the success of blinding. The therapists were aware of the type of treatment received by the patients. Patients were aware of the type of treatment who underwent but they were not aware about the type of stimulation (Group 1 stimulation vs Group 2 sham stimulation)" (Smania 2013 [pers comm]) |
| Blinding of participants and personnel (performance bias) Objective outcome measures | Low risk | Quote: "Asking the assessor to make an educated guess tested the success of blinding. The therapists were aware of the type of treatment received by the patients. Patients were aware of the type of treatment who underwent but they were not aware about the type of stimulation (Group 1 stimulation vs Group 2 sham stimulation)" (Smania 2013 [pers comm]) |
| Blinding of outcome assessment (detection bias) Subjective outcome measures | Low risk | Quote: "All patients were evaluated by the same examiner (an experienced internal coworker) who was not aware of the treatment received by the patients" |
| Blinding of outcome assessment (detection bias) Objective outcome measures | Low risk | Quote: "All patients were evaluated by the same examiner (an experienced internal coworker) who was not aware of the treatment received by the patients" |
| Incomplete outcome data (attrition bias) Subjective outcome measures | Low risk | All participants apparently completed the study. No treatment withdrawals, no losses to follow‐up, no trial group changes and no major adverse events were stated |
| Incomplete outcome data (attrition bias) Objective outcome measures | Low risk | All participants apparently completed the study. No treatment withdrawals, no losses to follow‐up, no trial group changes and no major adverse events were stated |
| Selective reporting (reporting bias) | Unclear risk | All outcomes stated in the methods section were reported, except muscle tone as measured by MAS |