[ARTICLE] Efficacy of physical therapy associated with botulinum toxin type A on functional performance in post-stroke spasticity: A randomized, double-blinded, placebo-controlled trial – Full Text

Abstract

The aim was to investigate if botulinum toxin type A (BTx-A) associated with physical therapy is superior to physical therapy alone in post stroke spasticity. A randomized, double-blinded controlled trial was performed in a rehabilitation unit on Northeastern, Brazil. Patients with post stroke spasticity were enrolled either to BTx-A injections and a pre-defined program of physical therapy or saline injections plus physical therapy. Primary endpoint was functional performance evaluated through time up and go test, six minutes walking test and Fugl-Meyer scale for upper limb. Secondary endpoint was spasticity improvement. Confidence interval was considered at 95%. Although there was a significant decrease in upper limbs flexor tonus (P<0.05) in the BTx-A group, there was no difference regarding functional performance after 9 months of treatment. When analyzing gait speed and performance, both groups showed a significant improvement in the third month of treatment, however it was not sustained over time. Although BTx-A shows superiority to improve muscle tone, physical therapy is the cornerstone to improve function in the upper limbs of post stroke patients.

Introduction

Stroke is the major cause of permanent and temporary functional incapacity worldwide among adults, affecting limb strength, motor control, balance and mobility.¹ Spasticity is characterized by an increase in tonic stretch reflex movement velocity dependent and post-stroke spasticity is frequently associated with poor functional performance due to abnormal postural patterns, leading to retractions, atrophy, selective movement control loss, limb weakness, fibrosis and structured contractions.² Moreover, impairment in activities of daily living (ADL) such as feeding, locomotion, proper hygiene and sleeping habits results in poor quality of life (QOL) and increased burden to relatives and caregivers.³

Several trials support the efficacy and safety of botulinum toxin type A (BTx-A) on spasticity treatment, reducing muscle permanent contraction and abnormal postural patterns, therefore, favoring rehabilitation process.⁴ Physical therapy has been described to be effective in post-stroke spastic patients through prevention of secondary incapacities and promoting behavioral reeducation, based on biomechanical and neurophysiological patterns. These techniques include physical exercises that focus on functional rehabilitation, reduction of limb spasticity, muscle strength improvement and sustained joint movement amplitude, besides proprioceptive and sensorial stimuli.⁵

Several trials with BTx-A show functional improvement in post-stroke spastic patients when compared to placebo, however, none have studied the impact of physical therapy alone.⁴

The aim of this trial was to investigate if BTx-A treatment associated with physical therapy is superior to physical therapy alone on functional performance in post-stroke spastic patients.[…]

 

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