Hornby 2008

Methods	RCT Method of randomisation: opaque sealed envelopes Blinding of outcome assessors: not done Adverse events: 8 events in control group and 3 events in experimental group Deaths: none Drop‐outs: 14 (10 in control group and 4 in experimental group) ITT: no ITT; analysis per protocol
Participants	Country: USA 62 participants (31 in treatment group, 31 in control group), 48 participants completed all training sessions and were analysed as per protocol Initially all participants were ambulatory at start of study Mean age: 57 years Inclusion criteria: hemiparesis of longer than 6 months' duration after patients with unilateral, supratentorial, ischaemic or haemorrhage stroke were recruited; no evidence of bilateral or brain stem lesions; able to walk 10 metres overground without physical assistance at speeds of 0.8 m/s at self‐selected velocity, using assistive devices and bracing below the knee as needed Exclusion criteria: significant cardiorespiratory/metabolic disease or other neurological or orthopaedic injury that may limit exercise participation or impair locomotion, size limitations for the harness/counterweight system or robotic orthosis, botulinum toxin therapy in the lower limbs within 6 months before enrolment, scores lower than 23 on the Mini Mental Status Examination, patients could not receive concurrent physical therapy
Interventions	2 arms: Control group received therapist‐assisted gait training, 12 sessions, each session lasted 30 minutes Experimental group received robotic‐assisted gait training using the Lokomat for the same time and frequency
Outcomes	Outcomes were recorded at baseline and after 12 sessions and at 6‐month follow‐up Primary outcome measures: self‐selected walking speed Secondary outcome measures: single‐limb stance time, step length asymmetry, 6‐minute walk test, modified Emory Functional Ambulation Profile, Berg Balance Scale, Frenchay Activities Index, physical component summary score of the Medical Outcomes Questionnaire Short Form 36, strength, Modified Ashworth Scale, Center for Epidemiological Studies‐Depression Scale
Notes	—
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	(Probably) shuffling envelopes
Allocation concealment (selection bias)	Low risk	Opaque sealed envelopes
Blinding of outcome assessment (detection bias) All outcomes	High risk	No blinding
Incomplete outcome data (attrition bias) All outcomes	High risk	'As‐treated' analysis done