Treadmill Training to improve mobility for people with sub-acute Stroke: A Phase II Feasibility Randomised Controlled Trial

Abstract

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 randomised controlled trial. Setting: Four hospital-based Stroke units Subjects: Participants within three months of stroke onset. Interventions: Participants were randomised 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 intervention and at six months follow up. The primary outcome was the Rivermead Mobility Index. Other measures included the Functional Ambulation Category, 10 metre walk, six minute walk, Barthel Index, Motor Assessment Scale, Stroke Impact Scale and a measure of confidence in walking. Results: Seventy seven patients were randomised, 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 (IQR): after eight weeks treadmill 5 (4-9), control 6 (4-11) p = 0.33; or six months follow-up treadmill 8.5 (3 -12), control 8 (6 - 12.5) p = 0.42. The frequency and intensity of intervention was low. Conclusions: 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 randomised trial is now required to explore treadmill training in normal clinical practice.