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 17 weeks 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 11-13 weeks. 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 4-10 weeks 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 11-13 weeks 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.