Articulated ankle-foot orthoses associated with home-based task-specific training improve functional mobility in patients with stroke: a randomized clinical trial

Abstract

Introduction: We compared fixed and articulated ankle-foot orthoses (AFOs) in home-based mobility tasks to assess short-term mobility, dynamic balance, quality of life, anxiety/depression, disability level, stroke severity, autonomy, human functioning, and patient satisfaction. Methods: This was a two-arm, parallel-group, randomized controlled trial with concealed allocation, assessor blinding, and a complete case analysis involving patients with chronic stroke. The participants were randomized into two groups: fixed (n = 24) and articulated (n = 23) AFOs. The AFOs were custom-fabricated, and both groups performed four-week home-based mobility tasks five days weekly. Primary outcome measures included changes in balance and mobility assessed using the Tinetti Performance-Oriented Mobility Assessment (POMA), Timed Up and Go (TUG) test, and Functional Ambulation Category (FAC). Secondary outcomes included quality of life, anxiety/depression, disability, stroke severity, autonomy, human functioning, and patient satisfaction. Results: In a between-group comparison, after adjusting for age, sex, stroke severity, and thrombolysis, the articulated AFO group showed better performance in the TUG test (p = 0.020; d = 0.93), POMA-Gait (p = 0.001; d = 0.53), POMA-Total (p = 0.048; d = 0.98), and FAC (p = 0.003; d = 1.03) than the fixed AFO group. Moreover, significant difference was noted in human functioning (moving around using equipment)between the groups (p = 0.047; d = 92). Conclusion: A program involving home-based mobility tasks and articulated AFOs improved functional mobility after stroke.