NCT01146587

Trial name or title	Comparative study of GangTrainer GT1, Lokomat and conventional physiotherapy (GALOP)
Methods	RCT with 3 arms
Participants	Inclusion criteria: first supratentorial stroke (ischaemic, haemorrhagic or intracerebral haemorrhage) resulting in hemiparesis; interval from stroke: 3 to 12 weeks; non‐ambulatory (FAC < 3); free sitting on bedside for 1 minute, with both feet on the floor and holding onto bedside by hands, Barthel Index 25 to 65 Exclusion criteria: unstable cardiovascular system (in case of doubt, only after approval by a internist); manifested heart diseases like labile compensated cardiac insufficiency (NYHA III), angina pectoris, myocardial infarction 120 days before study onset, cardiomyopathy, severe cardiac arrhythmia, severe joint misalignment (severe constriction of movement for hip, knee or ankle, or any combination of the 3: more than 20° fixed hip and knee extension deficit, or more than 20° fixed plantar flexion of the ankle); severe cognitive dysfunction, which does not allow for comprehension of the aims of this study; severe neurological or orthopaedic diseases (like polio, Parkinson´s disease), which massively affect mobility; deep vein thrombosis; severe osteoporosis; or malignant tumour disease
Interventions	Group A: 30 minutes of treatment on the GangTrainer GT1 and 30 minutes of conventional physiotherapy every workday for 8 weeks Group B: 30 minutes of treatment on the Lokomat and 30 minutes of conventional physiotherapy every workday for 8 weeks Group C: 60 minutes of conventional physiotherapy every workday for 8 weeks
Outcomes	Primary outcomes: FAC, modified Emory Functional Ambulation Secondary outcomes: Barthel Index, 10‐metre walk test, 6‐minute walk test on the floor, Medical Research Council, Rivermead Visual Gait Assessment (RVGA), EuroQol 5 Dimensions (EQ‐5D)
Starting date	August 2010
Contact information	Contact: Andreas Waldner, MD; +39 0471 471 471; waldner.andreas@villamelitta.it Contact: Christopher Tomelleri, MSc; +39 0471 471 471; christopher.tomelleri@villamelitta.it
Notes	Estimated enrolment: 120 Estimated study completion date: August 2013 Estimated primary completion date: August 2013 (final data collection date for primary outcome measure)