The effect of combined use of botulinum toxin type A and functional electric stimulation in the treatment of spastic drop foot after stroke: A preliminary investigation

Objective: To investigate the effect of combined botulinum toxin type A (BTX) and functional electric stimulation (FES) treatment on spastic drop foot in stroke. Design: Nonblinded randomized controlled trial. Setting: Hospitals. Participants: Consecutive sample of 21 ambulant adults within 1 year after stroke with a spastic drop foot, of whom 18 completed the study. Interventions: The treatment group received BTX injections (Dysport) on 1 occasion into the medial and lateral heads of the gastrocnemius (200U each) and tibialis posterior (400U each) muscles and FES, used on a daily basis for 16 weeks to assist walking. Both groups continued with physiotherapy at the same rate. Main Outcome Measures: Walking speed, Physiological Cost Index, Modified Ashworth Scale, Rivermead Motor Assessment, and Medical Outcomes Study 36-Item Short-Form Health Survey. Results: Walking speed increased over 12 weeks in both control (P=.020) and treatment groups (nonstimulated, P=.004; stimulated, P=.042). The baseline corrected (analysis of covariance) increase in mean walking speed at 12 weeks, relative to controls, was .04m/s (95% confidence interval [CI],.003-.090) without stimulation, and .09m/s (95% CI,.031-.150) with stimulation. Conclusions: Combined treatment effectively improved walking and function. A larger study is needed to quantify the treatment effect and to investigate its impact on quality of life.