Treadmill training to improve mobility for people with sub-acute stroke: a phase II feasibility randomized controlled trial

OBJECTIVE This phase II study investigated the feasibility and potential effectiveness of treadmill training versus normal gait re-education for ambulant and non-ambulant people with sub-acute stroke delivered as part of normal clinical practice. DESIGN A single-blind, feasibility randomized controlled trial. SETTING Four hospital-based stroke units. SUBJECTS Participants within three months of stroke onset. INTERVENTIONS Participants were randomized to treadmill training (minimum twice weekly) plus normal gait re-education or normal gait re-education only (control) for up to eight weeks. MAIN MEASURES Measures were taken at baseline, after eight weeks of intervention and at six-month follow-up. The primary outcome was the Rivermead Mobility Index. Other measures included the Functional Ambulation Category, 10-metre walk, 6-minute walk, Barthel Index, Motor Assessment Scale, Stroke Impact Scale and a measure of confidence in walking. RESULTS In all, 77 patients were randomized, 39 to treadmill and 38 to control. It was feasible to deliver treadmill training to people with sub-acute stroke. Only two adverse events occurred. No statistically significant differences were found between groups. For example, Rivermead Mobility Index, median (interquartile range (IQR)): after eight weeks treadmill 5 (4-9), control 6 (4-11) p = 0.33; or six-month follow-up treadmill 8.5 (3-12), control 8 (6-12.5) p = 0.42. The frequency and intensity of intervention was low. CONCLUSION Treadmill training in sub-acute stroke patients was feasible but showed no significant difference in outcomes when compared to normal gait re-education. A large definitive randomized trial is now required to explore treadmill training in normal clinical practice.