Early or delayed provision of an ankle-foot orthosis in patients with acute and subacute stroke: a randomized controlled trial.

Objective: (1) To study the effects of providing ankle-foot orthoses in subjects with (sub)acute stroke; and (2) to study whether the point in time at which an ankle-foot orthosis is provided post-stroke (early or delayed) influences these effects. Design: Randomized controlled trial. Setting: Rehabilitation centre. Subjects: Unilateral hemiparetic stroke subjects with indication for use of an ankle-foot orthosis and maximal six weeks post-stroke. Interventions: Subjects were randomly assigned to: early provision (at inclusion; Week 1) or delayed provision (eight weeks later; Week 9). Outcome measures: 10-metre walk test, 6-minute walk test, Timed Up and Go Test, stairs test, Functional Ambulation Categories, Berg Balance Scale, Rivermead Mobility Index and Barthel Index; assessed in Weeks 1, 3, 9 and 11. Results: A total of 33 subjects were randomized (16 early, 17 delayed). Positive effects of ankle-foot orthoses were found two weeks after provision, both when provided early (significant effects on all outcomes) or delayed (Berg Balance Scale p=0.011, Functional Ambulation Categories p=0.008, 6-minute walk test p=0.005, Timed Up and Go Test p=0.028). Comparing effects after early and delayed provision showed that early provision resulted in increased levels of improvement on Berg Balance Scale (+5.1 points, p=0.002), Barthel Index (+1.9 points, p=0.002) and non-significant improvements on 10-metre walk test (+0.14m/s, p=0.093) and Timed Up and Go Test (-5.4 seconds, p=0.087), compared with delayed provision. Conclusions: We found positive effects of providing ankle-foot orthoses in (sub)acute stroke subjects that had not used these orthoses before.