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卒中后早期上肢动员和触觉刺激疗法的剂量反应研究:I 期试验。

Dose-response study of mobilisation and tactile stimulation therapy for the upper extremity early after stroke: a phase I trial.

机构信息

Keele University, Keele, UK.

出版信息

Neurorehabil Neural Repair. 2011 May;25(4):314-22. doi: 10.1177/1545968310390223. Epub 2011 Jan 31.

Abstract

BACKGROUND

Physical therapy doses may need to be higher than provided in current clinical practice, especially for patients with severe paresis. The authors aimed to find the most effective and feasible dose of Mobilisation and Tactile Stimulation (MTS), which includes joint and soft-tissue mobilization and passive or active-assisted movement to enhance voluntary muscle contraction.

METHODS

This 2-center, randomized, controlled, observer-blinded feasibility trial compared conventional rehabilitation but no extra therapy (group 1) with conventional therapy plus 1 of 3 daily doses of MTS, up to 30 (group 2), 60 (group 3), or 120 (group 4) minutes for 14 days. The 76 participants had substantial paresis (Motricity Index [MI] < 61) a mean of 30 days (standard deviation [SD] = 20 days) after anterior circulation stroke. MTS was delivered using a standardized schedule of techniques (eg, sensory input, active-assisted movement). The primary outcome was the Motricity Index (MI) and secondary outcome was the Action Research Arm Test (ARAT) tested on day 16. Adverse events were monitored daily.

RESULTS

No difference was found in the change in control group MI compared with each of the 3 intervention groups (P = .593) or in the ARAT. Mean actual daily treatment time for all MTS groups was less than expected. The attrition rate was 1.3%. No adverse events related to overuse occurred.

CONCLUSION

The authors were not able to deliver a maximum dose of 120 minutes of daily therapy each day. The mean daily dose of MTS feasible for subsequent evaluation is between 37 and 66 minutes.

摘要

背景

物理治疗剂量可能需要高于目前临床实践所提供的剂量,尤其是对于严重瘫痪的患者。作者旨在找到最有效和可行的 Mobilisation 和 Tactile Stimulation(MTS)剂量,该方法包括关节和软组织的松动和被动或主动辅助运动,以增强自愿肌肉收缩。

方法

这是一项 2 中心、随机、对照、观察者盲法可行性试验,比较了常规康复但无额外治疗(第 1 组)与常规治疗加 3 种每日剂量的 MTS(分别为 30 分钟[第 2 组]、60 分钟[第 3 组]或 120 分钟[第 4 组]),持续 14 天。76 名参与者在前循环卒中后平均 30 天(标准差[SD] = 20 天)出现严重瘫痪(运动指数[MI] < 61)。MTS 使用标准化的技术方案(例如,感觉输入、主动辅助运动)进行。主要结局指标是运动指数(MI),次要结局指标是第 16 天的行动研究上肢测试(ARAT)。每天监测不良事件。

结果

与 3 个干预组中的任何一组相比,对照组 MI 的变化无差异(P =.593)或 ARAT 无差异。所有 MTS 组的实际每日治疗时间均低于预期。失访率为 1.3%。未发生与过度使用相关的不良事件。

结论

作者未能每天提供 120 分钟的最大剂量治疗。随后评估可行的 MTS 平均每日剂量在 37 至 66 分钟之间。

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