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急性卒中后极早期主动活动(AMOBES):一项随机对照试验。

AMOBES (Active Mobility Very Early After Stroke): A Randomized Controlled Trial.

作者信息

Yelnik Alain P, Quintaine Victorine, Andriantsifanetra Cedric, Wannepain Marie, Reiner Peggy, Marnef Hélène, Evrard Mathilde, Meseguer Elena, Devailly Jean Pascal, Lozano Monica, Lamy Catherine, Colle Florence, Vicaut Eric

机构信息

From the PRM Department, GH Lariboisière F. Widal, AP-HP, Paris Diderot University, UMR8257, Paris, France (A.P.Y., V.Q., C.A., M.W., H.M., M.E.); Neurological Department GH Lariboisière F. Widal, AP-HP, Paris Diderot University, Paris, France (P.R.); Department of Neurology and Stroke Centre (E.M.) and PRM Department (J.P.D., M.L.), GH Paris Nord Val de Seine, AP-HP, Paris Diderot University, Paris, France; Neurological Department (C.L.) and PRM Department (F.C.), Sainte Anne Hospital, Paris Descartes University, Paris, France; and Clinical Research Unit GH Lariboisière F. Widal, AP-HP, Paris Diderot University, Paris, France (E.V.).

出版信息

Stroke. 2017 Feb;48(2):400-405. doi: 10.1161/STROKEAHA.116.014803. Epub 2016 Dec 22.

Abstract

BACKGROUND AND PURPOSE

Intensive physical therapy (PT) facilitates motor recovery when provided during a subacute stage after stroke. The efficiency of very early intensive PT has been less investigated. We aimed to investigate whether intensive PT conducted within the first 2 weeks could aid recovery of motor control.

METHODS

This multicentre randomized controlled trial compared soft PT (20-min/d apart from respiratory needs) and intensive PT (idem+45 minutes of intensive exercises/day) initiated within the first 72 hours after a first hemispheric stroke. The primary outcome was change in motor control between day (D) 90 and D0 assessed by the Fugl-Meyer score. Main secondary outcomes were number of days to walking 10 m unassisted, balance, autonomy, quality of life, and unexpected medical events. All analyses were by intent to treat.

RESULTS

We could analyze data for 103 of the 104 included patients (51 control and 52 experimental group; 64 males; median age overall 67 [interquartile range 59-77], 67 right hemispheric lesions, 80 ischemic lesions, National Institutes of Health Stroke Scale score ≥8 for 82%). Fugl-Meyer score increased over time (P<0.0001), with no significant effect of treatment (P=0.29) or interaction between treatment and time (P=0.40). The median change in score between D90 and D0 was 27.5 (12-40) and 22.0 (12-56) for control and experimental groups (P=0.69). Similar results were found for the secondary criteria.

CONCLUSIONS

Very early after stroke, intensive exercises may not be efficient in improving motor control. This conclusion may apply to mainly severe stroke.

CLINICAL TRIAL REGISTRATION

URL: http://www.clinicaltrials.gov. Unique identifier: NCT01520636.

摘要

背景与目的

在中风后的亚急性期进行强化物理治疗(PT)有助于运动功能恢复。极早期强化PT的效果鲜少被研究。我们旨在探究在发病后2周内进行强化PT是否有助于运动控制的恢复。

方法

这项多中心随机对照试验比较了首次半球性中风后72小时内开始的温和PT(除呼吸需求外,每天20分钟)和强化PT(每天20分钟+45分钟强化训练)。主要结局是用Fugl-Meyer评分评估的第90天与第0天之间运动控制的变化。主要次要结局是独立行走10米所需天数、平衡能力、自主能力、生活质量和意外医疗事件。所有分析均采用意向性分析。

结果

纳入的104例患者中,103例的数据可进行分析(51例对照组和52例试验组;64例男性;总体中位年龄67岁[四分位间距59 - 77],67例为右侧半球病变,80例为缺血性病变,82%的患者美国国立卫生研究院卒中量表评分≥8分)。Fugl-Meyer评分随时间增加(P<0.0001),治疗无显著效果(P = 0.29),治疗与时间之间无显著交互作用(P = 0.40)。对照组和试验组第90天与第0天之间评分的中位变化分别为27.5(12 - 40)和22.0(12 - 56)(P = 0.69)。次要标准的结果相似。

结论

中风后极早期,强化训练可能对改善运动控制无效。这一结论可能主要适用于重度中风。

临床试验注册

网址:http://www.clinicaltrials.gov。唯一标识符:NCT01520636。

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