METHODS: Double-blind, randomized controlled trial.
METHODS: Laboratory within a free-standing rehabilitation hospital.
METHODS: A total of 94 stroke survivors with severe, chronic hand impairment were randomly assigned to 1 of 4 treatment groups.
METHODS: Participants received either a placebo or cyproheptadine hydrochloride in identical pill form. The daily dosage of cyproheptadine/placebo was gradually increased from 8 to 24 mg/d over 3 weeks and then maintained over the next 6 weeks while participants completed 18 therapy sessions. Therapy consisted of either (1) active practice of muscle activation patterns to play \"serious\" computer games or control a custom hand exoskeleton or (2) passive, cyclical finger stretching imposed by the exoskeleton.
METHODS: Hand control was evaluated with the primary outcome measure of time to complete the Graded Wolf Motor Function Test (GWMFT) and secondary outcome measures including finger strength and spasticity.
RESULTS: Across the 88 participants who completed the study, a repeated-measures analysis of variance revealed a significant effect of GroupxEvaluation interaction on GWMFT (F=1.996, P=.026). The 3 groups receiving cyproheptadine and/or actively practicing muscle activation pattern control exhibited significant reduction in mean time to complete the GWMFT tasks; roughly one-third of these participants experienced at least a 10% reduction in completion time. Gains were maintained at the 1-month follow-up evaluation. The group receiving placebo and passive stretching did not show improvement. No significant differences among groups were observed in terms of changes in strength or spasticity.
CONCLUSIONS: Despite chronic, severe impairment, stroke survivors were able to complete the therapy focused on muscle activations and achieved statistically significant improvement in hand motor control. Cyproheptadine hydrochloride is a potential complementary treatment modality for stroke survivors with hand impairment.
方法:双盲,随机对照试验。
方法:独立康复医院内的实验室。
方法:共有94名中风幸存者,慢性手损伤被随机分配到四个治疗组之一.
方法:参与者以相同的药丸形式接受安慰剂或盐酸赛庚啶。赛庚啶/安慰剂的每日剂量在三周内从8mg/天逐渐增加到24mg/天,然后在接下来的6周内维持,而参与者完成了18次治疗。治疗包括:(1)积极练习肌肉激活模式,玩“严肃”电脑游戏或控制定制手外骨骼,或(2)被动,由外骨骼施加的周期性手指拉伸。
方法:以完成Wolf运动功能测试(GWMFT)的时间为主要结局指标,以手指力量和痉挛为次要结局指标,对手部控制进行评估。
结果:在完成研究的88名参与者中,重复测量方差分析显示GroupxEvaluation交互作用对GWMFT有显著影响(F=1.996,p=0.026)。接受赛庚啶和/或积极练习肌肉激活模式控制的三组显示出完成GWMFT任务的平均时间显着减少;这些参与者中约有三分之一的完成时间至少减少了10%。在一个月的随访评估中保持了收益。接受安慰剂和被动拉伸的组未显示出改善。在强度或痉挛状态的变化方面,各组之间没有显着差异。
结论:尽管慢性,严重损害,卒中幸存者能够完成以肌肉活动为重点的治疗,在手运动控制方面取得统计学显著改善.盐酸赛庚啶为患有手损伤的中风幸存者提供了潜在的补充治疗方式。