Combined effects of robot‑assisted gait training and botulinum toxin type A on spastic equinus foot in patients with chronic stroke: a pilot, single blind, randomized controlled trial

Abstract

Background: Despite the growing evidence about the use of robotic gait training in neurorehabilitation, there is a scant literature about the combined effects of this innovative technological approach and a first‑line treatment for focal spasticity as botulinum toxin type A. In particular, to the best of our knowledge, no previous study evaluated if robotic gait training may enhance the antispastic effect of botulinum toxin type A.

Aim: To evaluate the combined effects of robot‑assisted gait training and botulinum toxin type A on spastic equinus foot in patients with chronic stroke.

Design: Pilot, single blind, randomized controlled trial.

Setting: University hospital.

Population: Twenty‑two adult outpatients with spastic equinus due to chronic stroke.

Methods: Participants were randomly assigned to two groups: patients allocated to the group 1 received robot‑assisted gait training (30 minutes a day for five consecutive days) after AbobotulinumtoxinA injection into the spastic calf muscles as well as patients allocated to the group 2 were only injected with AbobotulinumtoxinA into the same muscles. All patients were evaluated immediately before and one month after injection. The following outcome measures were considered: the modified Ashworth scale, the Tardieu scale and the 6-minute walking test.

Results: No difference was found between groups as to the modified Ashworth scale and the Tardieu scale measured at the affected ankle one month after botulinum toxin injection. A significant difference in the 6-minute walking test was noted between groups at the post‑treatment evaluation (P=0.045).

Conclusions: Our preliminary findings support the hypothesis that robot‑assisted gait training does not enhance the effect of botulinum toxin type A on spastic equinus foot in patients with chronic stroke.

Clinical rehabilitation impact: Our observations should be taken into account in daily clinical rehabilitation practice in order to develop effective treatment protocols based on the enhancement of antispastic drugs effect.