Combined botulinum toxin type A with modified constraint-induced movement therapy for chronic stroke patients with upper extremity spasticity: a randomized controlled study.

Background and Objective: 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.
Methods: 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.
Results: 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.
Conclusions: 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.