Foot drop stimulation versus ankle foot orthosis after stroke: 30-week outcomes.

BACKGROUND AND PURPOSE Drop foot after stroke may be addressed using an ankle foot orthosis (AFO) or a foot drop stimulator (FDS). The Functional Ambulation: Standard Treatment versus Electric Stimulation Therapy (FASTEST) trial was a multicenter, randomized, single-blinded trial comparing FDS and AFO for drop foot among people ≥ 3 months after stroke with gait speed ≤ 0.8 m/s. METHODS Participants (n=197; 79 females and 118 males; 61.14 ± 11.61 years of age; time after stroke 4.55 ± 4.72 years) were randomized to 30 weeks of either FDS or a standard AFO. Eight dose-matched physical therapy sessions were provided to both groups during the first 6 weeks of the trial. RESULTS There was significant improvement within both groups from baseline to 30 weeks in comfortable gait speed (95% confidence interval for mean change, 0.11-0.17 m/s for FDS and 0.12-0.18 m/s for AFO) and fast gait speed. However, no significant differences in gait speed were found in the between-group comparisons. Secondary outcomes (standard measures of body structure and function, activity, and participation) improved significantly in both groups, whereas user satisfaction was significantly higher in the FDS group than in the control group. CONCLUSIONS Using either an FDS or an AFO for 30 weeks yielded clinically and statistically significant improvements in gait speed and other functional outcomes. User satisfaction was higher in the FDS group. Although both groups did receive intervention, this large clinical trial provides evidence that FDS or AFO with initial physical therapy sessions can provide a significant and clinically meaningful benefit even years after stroke. Clinical Trial Registration Information- URL: http://www.clinicaltrials.gov. Unique Identifier: NCT01138995.