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强制性运动疗法对卒中后3至9个月上肢功能的影响:EXCITE随机临床试验

Effect of constraint-induced movement therapy on upper extremity function 3 to 9 months after stroke: the EXCITE randomized clinical trial.

作者信息

Wolf Steven L, Winstein Carolee J, Miller J Philip, Taub Edward, Uswatte Gitendra, Morris David, Giuliani Carol, Light Kathye E, Nichols-Larsen Deborah

机构信息

Department of Rehabilitation Medicine, Emory University School of Medicine, Atlanta, GA 30322, USA.

出版信息

JAMA. 2006 Nov 1;296(17):2095-104. doi: 10.1001/jama.296.17.2095.

Abstract

CONTEXT

Single-site studies suggest that a 2-week program of constraint-induced movement therapy (CIMT) for patients more than 1 year after stroke who maintain some hand and wrist movement can improve upper extremity function that persists for at least 1 year.

OBJECTIVE

To compare the effects of a 2-week multisite program of CIMT vs usual and customary care on improvement in upper extremity function among patients who had a first stroke within the previous 3 to 9 months.

DESIGN AND SETTING

The Extremity Constraint Induced Therapy Evaluation (EXCITE) trial, a prospective, single-blind, randomized, multisite clinical trial conducted at 7 US academic institutions between January 2001 and January 2003.

PARTICIPANTS

Two hundred twenty-two individuals with predominantly ischemic stroke.

INTERVENTIONS

Participants were assigned to receive either CIMT (n = 106; wearing a restraining mitt on the less-affected hand while engaging in repetitive task practice and behavioral shaping with the hemiplegic hand) or usual and customary care (n = 116; ranging from no treatment after concluding formal rehabilitation to pharmacologic or physiotherapeutic interventions); patients were stratified by sex, prestroke dominant side, side of stroke, and level of paretic arm function.

MAIN OUTCOME MEASURES

The Wolf Motor Function Test (WMFT), a measure of laboratory time and strength-based ability and quality of movement (functional ability), and the Motor Activity Log (MAL), a measure of how well and how often 30 common daily activities are performed.

RESULTS

From baseline to 12 months, the CIMT group showed greater improvements than the control group in both the WMFT Performance Time (decrease in mean time from 19.3 seconds to 9.3 seconds [52% reduction] vs from 24.0 seconds to 17.7 seconds [26% reduction]; between-group difference, 34% [95% confidence interval {CI}, 12%-51%]; P<.001) and in the MAL Amount of Use (on a 0-5 scale, increase from 1.21 to 2.13 vs from 1.15 to 1.65; between-group difference, 0.43 [95% CI, 0.05-0.80]; P<.001) and MAL Quality of Movement (on a 0-5 scale, increase from 1.26 to 2.23 vs 1.18 to 1.66; between-group difference, 0.48 [95% CI, 0.13-0.84]; P<.001). The CIMT group achieved a decrease of 19.5 in self-perceived hand function difficulty (Stroke Impact Scale hand domain) vs a decrease of 10.1 for the control group (between-group difference, 9.42 [95% CI, 0.27-18.57]; P=.05).

CONCLUSION

Among patients who had a stroke within the previous 3 to 9 months, CIMT produced statistically significant and clinically relevant improvements in arm motor function that persisted for at least 1 year. Trial Registration clinicaltrials.gov Identifier: NCT00057018.

摘要

背景

单中心研究表明,对于卒中后1年以上仍保留部分手部和腕部活动能力的患者,进行为期2周的强制性使用运动疗法(CIMT)可改善上肢功能,且这种改善至少可持续1年。

目的

比较为期2周的多中心CIMT方案与常规护理对既往3至9个月内首次发生卒中的患者上肢功能改善的效果。

设计与地点

肢体强制性使用疗法评估(EXCITE)试验,这是一项前瞻性、单盲、随机、多中心临床试验,于2001年1月至2003年1月在美国7家学术机构进行。

参与者

222例主要为缺血性卒中的患者。

干预措施

参与者被分配接受CIMT(n = 106;在使用偏瘫手进行重复性任务练习和行为塑造时,给未受影响的手戴上约束手套)或常规护理(n = 116;从完成正式康复后不进行治疗到药物或物理治疗干预);患者按性别、卒中前优势侧、卒中侧和瘫痪手臂功能水平进行分层。

主要结局指标

Wolf运动功能测试(WMFT),一种基于实验室时间和力量的运动能力及质量(功能能力)的测量方法;以及运动活动日志(MAL),一种测量30项常见日常活动执行情况的好坏及频率的方法。

结果

从基线到12个月,CIMT组在WMFT执行时间(平均时间从19.3秒降至9.3秒[降低52%],而对照组从24.0秒降至17.7秒[降低26%];组间差异为34%[95%置信区间{CI},12%-51%];P<.001)、MAL使用量(在0-5分制上,从1.21增加到2.13,而对照组从1.15增加到1.65;组间差异为0.43[95%CI,0.05-0.80];P<.001)和MAL运动质量(在0-5分制上,从1.26增加到2.23,而对照组从1.18增加到1.66;组间差异为0.48[95%CI,0.13-0.84];P<.001)方面均比对照组有更大改善。CIMT组自我感知的手部功能困难程度(卒中影响量表手部领域)降低了19.5,而对照组降低了10.1(组间差异为9.42[95%CI,0.27-18.57];P=.05)。

结论

在既往3至9个月内发生卒中的患者中,CIMT在手臂运动功能方面产生了具有统计学意义且临床相关的改善,且这种改善至少持续1年。试验注册 clinicaltrials.gov标识符:NCT00057018。

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