The effect of ankle-foot orthoses on fall/near fall incidence in patients with (sub-)acute stroke: A randomized controlled trial.

Falls are commonly reported post-stroke. Ankle-foot orthoses (AFOs) are often provided to improve safety and walking, but the effect of their use in the reduction of falls after stroke is unknown. A randomized controlled trial (RCT) on the effects of AFO-provision after stroke was performed. Effects on clinical scales, 3D-gait kinematics and muscle-activity were previously reported. This paper aims to study the effects of AFO-provision on occurrence and circumstances of falls/near falls. The RCT included unilateral hemiparetic stroke patients. AFOs were provided either early (study week 1) or delayed (study week 9). Both groups were compared in the first eight weeks of the study and diaries were used to register falls/near falls and their circumstances. Follow-up measurements were performed in week 9-52, in which both groups were provided with AFOs. Functional Ambulation Categories and Berg Balance Scale were assessed to determine walking independence and balance, respectively. Last known scores were noted in case of an incident. Thirty-three subjects were included (16 early, 17 delayed). In week 1-8, the early group, who were provided with AFOs, fell significantly more frequently compared with the delayed group, 11 versus 4 times, respectively (Incidence Rate Ratio = 2.9, p = 0.039). Out of the falls recorded in the early group, 63.6% occurred without wearing AFOs. Most of these falls occurred during transfers (36.4%) and standing (27.3%), and notably it were the subjects who did not have independent walking ability. No differences were found for near falls in week 1-8, or for falls/near falls in week 9-52. Six severe consequences (including fractures) were reported from a fall. To conclude, the subjects provided with AFOs early after stroke reported a higher number of falls, compared to the subjects that had not yet been provided with AFOs. However, in the subjects provided with AFOs, 63.6% of the falls occurred whilst without wearing the AFO. Furthermore, the majority of these incidents took place whilst subjects had no independent walking ability. This raises an interesting question of the importance of careful instructions to patients and their relatives, and the influence of potential cognitive impairments on the ability of the subjects to take on these instructions.