The effects of onabotulinum toxin A injection into rectus femoris muscle in hemiplegic stroke patients with stiff-knee gait: a placebo-controlled, nonrandomized trial.

Objective: This study aimed to compare the efficacy of onabotulinum toxin A (onabot) injection into the rectus femoris muscle with that of placebo in the treatment of hemiplegic stroke patients presenting with stiff-knee gait.

Design: Twenty-five chronic hemiparetic stroke patients presenting with a stiff-knee gait were included in this study. Fifteen patients received 100-125 U of onabot, and 10 patients received placebo into the rectus femoris muscle. Three-dimensional gait analysis, energy expenditure, 10-m and 6-min walk tests, and spasticity level of the rectus femoris were evaluated at baseline and 2 mos posttreatment.

Results: The mean age of patients who received onabot was 53.86 ± 14.74 yrs and of those who received placebo was 59.00 ± 8.11 yrs. At study onset, groups were similar with respect to all parameters (P > 0.05). We observed significant improvement in knee flexion (7 degrees average) during swing and a reduction in energy cost of 0.8-J/kg per meter response to injection of 100-125 U of onabot into the rectus femoris muscle. Onabot treatment significantly reduced muscle tone and improved knee kinematics, energy expenditure during walking, and functional assessments at 2 mos (P < 0.05); however, placebo had no effects on these parameters. Moreover, maximum knee flexion at swing and energy expenditure in the onabot group was significantly better than placebo at 2 mos (P < 0.05).

Conclusions: Our results showed the superiority of onabot over placebo in increasing knee flexion during swing phase and decreasing energy expenditure. The application of onabot into the rectus femoris muscle in stroke patients who presented with stiff-knee gait may be a treatment option to provide independent, safe, and less tiring ambulation.