Background. OnabotulinumtoxinA injections improve upper-limb spasticity after stroke, but their effect on arm function remains uncertain. Objective. To determine whether a single treatment with onabotulinumtoxinA injections combined with upper-limb physiotherapy improves grasp release compared with physiotherapy alone after stroke. Methods. A total of 28 patients, at least 1 month poststroke, were randomized to receive either onabotulinumtoxinA or placebo injections to the affected upper limb followed by standardized upper-limb physiotherapy (10 sessions over 4 weeks). The primary outcome was time to release grasp during a functionally relevant standardized task. Secondary outcomes included measures of wrist and finger spasticity and strength using a customized servomotor, clinical assessments of stiffness (modified Ashworth Scale), arm function (Action Research Arm Test [ARAT], Nine Hole Peg Test), arm use (Arm Measure of Activity), Goal Attainment Scale, and quality of life (EQ5D). Results. There was no significant difference between treatment groups in grasp release time 5 weeks post injection (placebo median = 3.0 s, treatment median = 2.0 s; t(24) = 1.20; P = .24; treatment effect = −0.44, 95% CI = −1.19 to 0.31). None of the secondary measures passed significance after correcting for multiple comparisons. Both groups achieved their treatment goals (placebo = 65%; treatment = 71%), and made improvements on the ARAT (placebo +3, treatment +5) and in active wrist extension (placebo +9°, treatment +11°). Conclusions. In this group of stroke patients with mild to moderate spastic hemiparesis, a single treatment with onabotulinumtoxinA did not augment the improvements seen in grasp release time after a standardized upper-limb physiotherapy program.

中文翻译：

---

中风后抓握释放肉毒杆菌疗法的探索性随机双盲安慰剂对照试验 (ProOMBiS)

背景。OnabotulinumtoxinA 注射剂可改善中风后的上肢痉挛状态，但它们对手臂功能的影响仍不确定。客观的。确定与中风后单独的物理治疗相比，肉毒杆菌毒素 A 注射联合上肢物理治疗的单一治疗是否能改善抓握松脱。方法。总共 28 名患者，在中风后至少 1 个月，随机接受受影响的上肢注射肉毒杆菌毒素 A 或安慰剂，然后进行标准化的上肢理疗（4 周内 10 次）。主要结果是在功能相关的标准化任务中释放抓握的时间。次要结果包括使用定制伺服电机测量手腕和手指的痉挛和力量、僵硬的临床评估（修改的 Ashworth 量表）、手臂功能（行动研究手臂测试 [ARAT]、九孔钉测试）、手臂使用（手臂活动测量）、目标实现量表和生活质量 (EQ5D)。结果。注射后 5 周的抓握释放时间在治疗组之间没有显着差异（安慰剂中位数 = 3.0 s，治疗中位数 = 2.0 s；t(24) = 1.20；P = .24；治疗效果 = -0.44，95% CI = -1.19 到 0.31）。在校正多重比较后，没有任何次要测量通过显着性。两组均达到了治疗目标（安慰剂=65%；治疗=71%），并在ARAT（安慰剂+3，治疗+5）和主动腕伸（安慰剂+9°，治疗+11°）方面有所改善。结论。在这组轻中度痉挛性偏瘫脑卒中患者中，