Geroin 2011
| Methods | RCT Method of randomisation: software‐generated randomisation scheme Blinding of outcome assessors: no Adverse events: control group none; experimental groups none Deaths: none Drop‐outs: none ITT: yes | |
| Participants | Country: Italy 30 participants (10 in treatment group 1, 10 in treatment group 2 and 10 in control group) Initially 5 in treatment group and 7 in control group were ambulatory at start of study Mean age: not stated Inclusion criteria: at least 12 months from their first unilateral ischaemic stroke; age < 75 years; European Stroke Scale score between 75 and 85; Mini Mental State Examination score ≧ 24; ability to maintain standing position without aids for at least 5 minutes; ability to walk independently for at least 15 metres with the use of walking aids (cane and orthoses) Exclusion criteria: preceding epileptic fits; an electroencephalography suspect of elevated cortical excitability; metallic implants within the brain and previous brain surgery; medications altering cortical excitability or with a presumed effect on brain plasticity; posterior circulation stroke; deficits of somatic sensation involving the paretic lower limb; presence of vestibular disorders or paroxysmal vertigo; presence of severe cognitive or communicative disorders; presence of other neurological or orthopaedic conditions involving the lower limbs; presence of cardiovascular comorbidity; performance of any type of rehabilitation treatment in the three months before start of study | |
| Interventions | 3 arms:
All participants received ten 50‐minute treatment sessions, 5 days a week, for 2 consecutive weeks |
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| Outcomes | Outcomes were recorded at baseline and after 2 weeks:
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| Notes | We combined the results of both robotic‐assisted groups (arms 1 and 2) as a single group and compared them with the results of the control group (arm 3) | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Software‐generated list |
| Allocation concealment (selection bias) | Low risk | Central allocation |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Not done |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing outcome data |