The Effect of Botulinum Toxin Type A Injection in the Rectus Femoris in Stroke Patients Walking With a Stiff Knee Gait: A Randomized Controlled Trial

Abstract

Background Over activity of the rectus femoris is often cited as a main cause for stiff knee gait (SKG). Botulinum toxin (BoNT) can be used to reduce this over activity. Inconsistent results for the effect of BoNT injections were found in literature which can possibly be explained by the study design as these were uncontrolled or non-randomized studies. Objective To conduct a randomized controlled trial (RCT) to investigate the effect of botulinum toxin type A (BoNT-A) injections in the rectus femoris on gait kinematics and functional outcome in adult stroke patients. Methods Twenty-six participants were included in this triple-blind cross-over RCT. The intervention consisted of an injection with BoNT-A. Placebo is an injection with saline. Besides knee and hip kinematics, functional outcomes were measured. Results Comparison of the effect of BoNT-A injection to placebo injection showed a significant increase in peak knee flexion and knee range of motion of 6.7° and 4.8° respectively. There was no difference in hip kinematics. In functional outcomes, only the 6 Minute Walking Test showed a significant increase of 18.3 m. Conclusions BoNT-A injections in the rectus femoris is a valuable treatment option for stroke patients walking with a SKG to improve knee kinematics. To study the effect on functional outcome more research is necessary with different functional outcome measures that can capture the effect in kinematics. It is important to use kinematic measurements to demonstrate effects in quality of movement that are not captured by commonly used functional outcome measurements post stroke. Clinical Trial Registration: https://trialsearch.who.int/Trial2.aspx?TrialID=NTR2169