Combination therapy with repetitive facilitative exercise program and botulinum toxin type A to improve motor function for the upper-limb spastic paresis in chronic stroke: A randomized controlled trial

Abstract

Study design: An open-label, randomized, controlled, observer-blinded trial.

Introduction: Repetitive facilitative exercise (RFE) is a movement therapy to recover from hemiparesis after stroke. However, improvement is inhibited by spasticity. Recently, botulinum toxin type A (BoNT-A) injection has been shown to reduce spasticity.

Purpose: To examine the combined effect of an RFE program and BoNT-A treatment on upper-limb spastic paresis in chronic stroke.

Methods: Forty chronic stroke inpatients with upper-limb spastic paresis (Brunnstrom stage ≥III and Modified Ashworth Scale [MAS] score ≥1) were enrolled. Subjects were randomized into 2 groups of 20 each and received 4 weeks of treatment. The intervention group received RFE and BoNT-A injection; the control group underwent RFE only. Assessments were performed at baseline and at study conclusion. The primary outcome was change in Fugl-Meyer Assessment score for the upper extremity (FMA). The Action Research Arm Test (ARAT), active range of motion, Box and Block Test, and MAS were also evaluated.

Results: All participants completed this study. After 4 weeks, the intervention group evidenced a significantly greater increase in FMA score (median 11.0 [range 4-20]) than the control group (median 3.0 [range 0-9]) (P < .01, r = 0.79); as well as improvements in the other measures such as ARAT (median 12.5 [range 4-22] vs 7 [0-13]) (P < .01, r = 0.6), and MAS in the elbow flexors (median -1.5 [range -2 to 0] vs -1 [-2 to 0]) (P < .01, r = 0.45).

Discussion: A high degree of repetitive volitional movement induced by the facilitative technique with concomitant control of spasticity by BoNT-A injection might increase efficiency of motor learning with continuous movement of the affected upper-limb.

Conclusions: The combination of RFE and BoNT-A for spastic paresis might be more effective than RFE alone to improve upper-limb motor function and to lessen impairment in chronic stroke.

Keywords: Botulinum toxin; Exercise therapy; Hemiplegia; Muscle spasticity; Rehabilitation; Stroke.