Abstract：
OBJECTIVE: To examine a treatment for upper extremity impairment in stroke survivors that combines administration of cyproheptadine hydrochloride with repetitive practice focused on control of muscle activation patterns.
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.
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.
摘要：
目的：研究一种治疗中风幸存者上肢损伤的方法，该方法将盐酸赛庚啶的给药与专注于控制肌肉激活模式的重复练习相结合。
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。
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。
