Sale 2012

Trial name or title	Robot walking rehabilitation in stroke patients
Methods	RCT with 3 arms
Participants	Inclusion criteria: between the ages of 18 and 95 years, able to walk 25 feet unassisted or with assistance, first acute event of cerebrovascular stroke, unilateral paresis, ability to understand and follow simple instructions, ability to walk without assistance before stroke, endurance sufficient to stand at least 20 minutes unassisted per participant report Exclusion criteria: unable to understand instructions required by the study (Informed Consent Test of Comprehension), medical or neurological comorbidities that might contribute to significant gait dysfunction, uncontrolled hypertension > 190/110 mm Hg, significant symptoms of orthostasis when standing up, circulatory problems, history of vascular claudication or significant (+ 3) pitting oedema, lower extremity injuries or joint problems (hip or leg) that limit range of motion or function or cause pain with movement, bilateral impairment, severe sensory deficits in the paretic upper limb, cognitive impairment or behavioural dysfunction that would influence the ability to comprehend or participate in the study, women who are pregnant or lactating or both
Interventions	EXP group: robot G‐EO: each participant will be asked to perform 15 sessions (3 to 5 days a week for 4 up to 5 weeks) consisting of a treatment cycle using the GE‐O system device, according to individually tailored exercise scheduling CTL group: treadmill training: each participant will be asked to perform 15 sessions (3 to 5 days a week for 4 up to 5 weeks) consisting of a treatment cycle using the treadmill system device, according to individually tailored exercise scheduling CTL group: ground treatment: Ground Control Group (cCG): each participant will be asked to perform 15 sessions (3 to 5 days a week for 4 up to 5 weeks) of traditional lower limb physiotherapy
Outcomes	Outcomes will be assessed at baseline and at 6 months follow‐up: Primary outcomes: 6‐Minute Walk Test Secondary outcomes: Fugl‐Meyer Assessment (lower limb) Borg scale gait parameters with EMG FAC Walk Handicap Scale (WHS)
Starting date	September 2012
Contact information	Contact: Patrizio Sale, MD Email: patrizio.sale@gmail.com Contact: Marco Franceschini, MD Email: marco.franceschini@sanraffaele.it
Notes	Estimated enrolment: 90 Estimated study completion date: September 2015 Estimated primary completion date: August 2014 (final data collection date for primary outcome measure)