Dynamic splinting after treatment with botulinum toxin type-A: a randomized controlled pilot study. Combined botulinum toxin type A with modified constraint-induced movement therapy for chronic stroke patients with upper extremity spasticity: a randomized controlled study. 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.
Over 1.5 million Americans are diagnosed with a stroke each year, and excessive flexion or extension (hypertonia) of upper extremity joints are common secondary conditions. The purpose of this study was to compare the efficacy of botulinum toxin type-A and manual therapy, with the adjunct treatment of dynamic splinting on range of motion, spasticity, and elbow flexor hypertonia, in a randomized trial.
                Thirty-six subjects were recruited for this pilot study and all exhibited hypertonia in elbow flexion. Six patients were excluded due to noncompliance. Testing was done with pre/post active range of motion in elbow extension, and the Modified Ashworth Scale (extension) for spasticity. All patients received the current standard of care: botulinum toxin type-A injections and manual therapy. Experimental patients were randomly assigned adjunct treatment with Elbow Extension Dynasplint.
                Thirty patients completed the study (mean age [SD] 52+/-17 years). The percentage of change in active range of motion in elbow extension was greater for the experimental than for control subjects (33.5% vs. 18.7%). The Modified Ashworth Scale (extension) scores showed comparable changes of a mean 9.3% improvement for experimental versus 8.6% for the control subjects.
                This study confirmed the efficacy of botulinum toxin type-A in tone management and occupational therapy in contracture reduction. It also showed the value of dynamic splinting in maintaining gains in range of motion. Botulinum toxin type A (BtxA) injection and modified constraint-induced movement therapy (mCIMT) are both promising approaches to enhance recovery after stroke. The combined application of these 2 promising modalities has rarely been studied. The aim was to investigate whether combined BtxA and mCIMT would improve spasticity and upper extremity motor function more than BtxA plus conventional rehabilitation in chronic stroke patients with upper extremity spasticity.
                In a prospective, randomized controlled, observer-blinded trial with 6-month follow-up, 32 patients (>or=1 year after stroke) with ability to actively extend >10 degrees at metacarpophalangeal and interphalangeal joints and 20 degrees at wrist of the affected upper limb were randomized to receive BtxA + mCIMT (combination group) or BtxA + conventional rehabilitation (control group) for 2 hours/day, 3 days/week for 3 months.The primary outcome assessed spasticity on the Modified Ashworth Scale. Secondary outcomes assessed real-world arm function (Motor Activity Log), laboratory motor activity (Action Research Arm Test), and patients' global satisfaction.
                A total of 32 stroke patients were recruited, and 29 completed the study. Spasticity significantly improved in all subjects at 4 weeks and 3 months postinjection without between-group differences.The combination group showed significantly greater improvements in elbow, wrist, and finger spasticity (P = .019, P = .019, and P < .001, respectively), affected upper extremity real-world arm function (P < .001) and laboratory motor activity (P < .001) than the control group at 6-month postinjection. Patients reported considerable satisfaction and no serious adverse events occurred.
                Combining BtxA and mCIMT is an effective and safe intervention for improving spasticity and motor function in chronic stroke patients. The results are promising enough to justify further studies. We recommend future research to address the likely need for including rehabilitation with BtxA to improve function in patients with poststroke spasticity. 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.
                Randomized controlled trial.
                Outpatient spasticity clinic.
                Participants (N=23) had chronic spastic hemiparesis with moderate-severe hand impairment based on Chedoke-McMaster Assessment greater than or equal to 2.
                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.
                Motor Activity Log (MAL)-Observation was the primary outcome. Secondary outcomes were Action Research Arm Test (ARAT) and MAL-Self-Report.
                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 sustained at week 12 (P=.032). However, there were no significant differences between the FES and no-FES groups for any outcome variable over time.
                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.
At best there was 'low level' evidence for the effectiveness of outpatient MD rehabilitation in improving active function and impairments following BoNT for upper limb spasticity in adults with chronic stroke. No trials explored the effect of MD rehabilitation on 'passive function' (caring for the affected limb), caregiver burden, or the individual's priority goals for treatment. The optimal types (modalities, therapy approaches, settings) and intensities of therapy for improving activity (active and passive function) in adults and children with post-stroke spasticity, in the short and longer term, are unclear. Further research is required to build evidence in this area.