Morone 2011

Methods	RCT Method of randomisation: by computer program Blinding of outcome assessors: stated as 'yes' Adverse events: control group 4; experimental group 3 Deaths: none Drop‐outs: (in this study defined as discontinued intervention) 12 in robotic groups and 9 in control groups ITT: yes
Participants	Country: Italy 48 participants (12 in treatment group 1, 12 in treatment group 2, 12 in control group 1 and 12 in control group 2) All participants were non‐ambulatory at start of study Mean age: 62 years Inclusion criteria: hemiplegia/hemiparesis in the subacute phase with significant gait deficits (FAC < 3) caused by a first‐ever stroke, lesions that were confirmed by computed tomography or magnetic resonance imaging and age between 18 and 80 years Exclusion criteria: presence of subarachnoid haemorrhages, sequelae of prior cerebrovascular accidents or other chronic disabling pathologies, orthopaedic injuries that could impair locomotion, spasticity that limited lower extremity range of motion to less than 80%, sacral skin lesions, Mini Mental State Examination (MMSE) score < 24 and hemispatial neglect, as evaluated by a neuropsychologist
Interventions	2 arms (including strata for motor function): After first week post admission, participants performed 20 robotic sessions (5 times per week for 4 weeks) instead of a second session of standard physiotherapy; this session lasted 40 minutes, 20 of which consisted of active GT therapy (the remaining 20 minutes were allocated for the participant's preparation, parameter setting and rest breaks as needed) After first week of admission, participants performed two daily physiotherapy sessions. One was dedicated to walking training, consisting of 20 sessions of 40‐minute therapy (5 times per week), instead of a second session of standard physiotherapy. In light of the participant's ability, the walking therapy was focused on trunk stabilization, weight transfer to the paretic leg and walking between parallel bars or on the ground. If necessary, the participant was helped by one or two therapists and walking aids The standard physiotherapy, shared by both groups, was focused on facilitation of movement on the paretic side and upper limb exercises, as well as improving balance, standing, sitting and transferring
Outcomes	Outcomes were recorded by a physician, blinded to the treatment, at baseline, after 4 weeks of the intervention, and at hospital discharge Primary outcome: walking ability (as measured by FAC) Secondary outcomes: assessments of mobility function and ability level, evaluated by lower‐leg Ashworth (sum of scores for hip, knee and ankle), Rivermead Mobility Index, Motricity Index, Trunk Control Test, Canadian Neurological Scale, Barthel index, Rankin Scale, 6‐minute walk test on a 20‐m path and 10‐m walk test at a self‐selected speed
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Generated electronically by www.random.org
Allocation concealment (selection bias)	Low risk	Central allocation
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Yes
Incomplete outcome data (attrition bias) All outcomes	Low risk	ITT done; missing outcome data balanced in numbers across intervention groups, with similar reasons for missing data across groups