OBJECTIVE: To evaluate the longer term effects of electromechanical gait trainers (GT) combined with conventional physiotherapy on health status, function and ambulation in people with sub-acute stroke, in comparison to conventional physiotherapy given alone. DESIGN: A randomised controlled trial with intention-to-treat analysis. SETTING: A Community Hospital in Singapore. PARTICIPANTS: 106 non-ambulant individuals recruited approximately one month post-stroke. INTERVENTIONS: Both groups received 45 minutes of physiotherapy 6 times per week for 8 weeks, as follows: the GT group received 20 minutes of GT training and 5 minutes of stance/gait training in contrast to 25 minutes of stance/gait training for the control group, and both groups completed 10 minutes of standing and 10 minutes of cycling. MAIN OUTCOME MEASURES: The primary outcome was Functional Ambulation Category (FAC). Secondary outcomes were Barthel Index (BI), gait speed and endurance, and the Stroke Impact Scale (SIS). Measures were taken at baseline, 4, 8, 12, 24 and 48 weeks. RESULTS: Generalised linear model analysis showed significant improvement over time (independent of group) for FAC, BI, SIS Physical and SIS participation. However no significant group x time or group differences were observed for any of the outcome variables after generalised linear model analysis. CONCLUSIONS: The use of GT combined with conventional physiotherapy can be as effective as conventional physiotherapy applied alone for people with sub-acute stroke.

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