Six-month effects of early or delayed provision of an ankle-foot orthosis in patients with (sub)acute stroke: a randomized controlled trial

Objective: To study the six-month clinical effects of providing ankle-foot orthoses at different moments (early or delayed) in (sub)acute stroke; this is a follow-up to a published trial. Design: Randomized controlled trial. Setting: Rehabilitation centre. Subjects: Unilateral hemiparetic stroke subjects maximal six weeks post-stroke with indication for ankle-foot orthosis use. Interventions: Subjects were randomly assigned to early (at inclusion; week 1) or delayed provision (eight weeks later; week 9). Outcome measures: Functional tests assessing balance and mobility were performed bi-weekly for 17weeks and at week 26. Results: In all, 33 subjects were randomized. No differences at week 26 were found between both groups for any of the outcome measures. However, results suggest that early provision leads to better outcomes in the first 11-13weeks. Berg Balance Scale (P=0.006), Functional Ambulation Categories (P=0.033) and 6-minute walk test (P<0.001) showed significantly different patterns over time. Clinically relevant but statistically non-significant differences of 4-10weeks in reaching independent walking with higher balance levels were found, favouring early provision. Conclusion: No six-month differences in functional outcomes of providing ankle-foot orthoses at different moments in the early rehabilitation after stroke were found. Results suggest that there is a period of 11-13weeks in which early provision may be beneficial, possibly resulting in early independent and safe walking. However, our study was underpowered. Further research including larger numbers of subjects is warranted.