Cyclic Functional Electrical Stimulation Does Not Enhance Gains in Hand Grasp Function When Used as an Adjunct to OnabotulinumtoxinA and Task Practice Therapy: A Single-Blind, Randomized Controlled Pilot Study

Objective: To determine whether onabotulinumtoxinA injections and task practice training with or without functional electrical stimulation (FES) improve upper limb motor function in chronic spastic hemiparesis. Design: Randomized controlled trial. Setting: Outpatient spasticity clinic. Participants: Participants (N=23) had chronic spastic hemiparesis with moderate-severe hand impairment based on Chedoke-McMaster Assessment greater than or equal to 2. Interventions: OnabotulinumtoxinA injections followed by 12 weeks of postinjection task practice. Participants randomly assigned to FES group were also fitted with an orthosis that provided FES. Main Outcome Measures: Motor Activity Log (MAL) Observation was the primary outcome. Secondary outcomes were Action Research Arm Test (ARAT) and MAL-Self-Report. Results: For the entire cohort. MAL-Observation mean item scores improved significantly from baseline to week 6 (P=.005) but did not remain significant at week 12. MAL-Self-Report mean item scores improved significantly (P=.009) from baseline to week 6 and remained significantly higher (P=.014) at week 12. ARAT total scores also improved significantly from baseline to week 6 (P=.018) and were sus-tamed at week 12 (P=.032). However, there were no significant differences between the FES and no-FES groups for any outcome variable over time. Conclusions: Rehabilitation strategies that combine onabotulinumtoxinA injections and task practice therapy are feasible and effective in improving upper-limb motor function and reducing spasticity in patients with chronic spastic hemiparesis. However, the cyclic FES protocol used in this study did not increase gains achieved with the combination of onabotulinumtoxinA and task practice alone.