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. 2013 Jul 25;2013(7):CD006185. doi: 10.1002/14651858.CD006185.pub3

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:
  • Robot‐assisted gait training (Gait Trainer GT1) combined with transcranial direct current stimulation

  • Robot‐assisted gait training (Gait Trainer GT1) combined with sham transcranial direct current stimulation

  • Walking overground


All participants received ten 50‐minute treatment sessions, 5 days a week, for 2 consecutive weeks
Outcomes Outcomes were recorded at baseline and after 2 weeks:
  • Primary outcomes were the 6‐minute walk test and the 10‐m walking test

  • Secondary outcomes were spatiotemporal gait parameters, Functional Ambulation Categories, Rivermead Mobility Index, Motricity Index leg subscore and Modified Ashworth Scale

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