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有害和无害热刺激对上急性脑卒中患者上肢运动功能恢复的影响无差异:一项 6 个月随访的随机对照试验。

No Difference Between Noxious and Innocuous Thermal Stimulation on Motor Recovery of Upper Extremity in Patients With Acute Stroke: A Randomized Controlled Trial With 6-Month Follow-up.

机构信息

Department of Physical Therapy, Kaohsiung Medical University, Kaohsiung, Taiwan(∗).

Department of Physical Therapy, Kaohsiung Medical University, Kaohsiung, Taiwan(†).

出版信息

PM R. 2017 Dec;9(12):1191-1199. doi: 10.1016/j.pmrj.2017.05.012. Epub 2017 Jun 10.

DOI:10.1016/j.pmrj.2017.05.012
PMID:28610960
Abstract

BACKGROUND

Thermal stimulation (TS) has been developed and incorporated into stroke rehabilitation. However, whether noxious and innocuous TS induce the same effects on motor function recovery after stroke is still unknown. A comparative study of different temperature combination regimens is needed.

OBJECTIVE

To compare the short- and long-term effectiveness between noxious and innocuous TS on motor recovery of upper extremity in patients with acute stroke.

DESIGN

Randomized, controlled trial with concealed allocation, intention-to-treat analysis and blinded outcome assessors.

SETTING

A university hospital rehabilitation department in Taiwan.

PARTICIPANTS

A total of 79 patients with acute ischemic stroke were recruited. The majority had moderate to severe motor impairment of the upper extremity (UE).

INTERVENTION

In addition to traditional rehabilitation, the experimental group (n = 39) underwent noxious TS (heat pain 46-47°C/cold pain 7-8°C), and the control group (n = 40) received innocuous TS (heat 40-41°C/cold 20-21°C). TS intervention was applied for 30 minutes once per day and for a total of 20-24 times during hospital stay. A custom-made TS instrument, comprising 2 thermal stimulators and their respective thermal pads constructed in a closed-loop system, was used.

OUTCOMES

The Fugl-Meyer upper extremity score (the primary outcome), Action Research Arm Test, Motricity Index, Barthel Index, and modified Ashworth scale (the secondary outcomes) were administered by a blinded assessor at baseline, post-12th TS, post-intervention, 1-month, and 6-month follow-ups.

RESULTS

No significant differences between groups were found on the primary outcome at postintervention and follow-up assessments. At 1-month follow-up, the innocuous group showed a small effect (partial η = 0.02) that was greater than that of the noxious group, but that effect was eliminated at 6 months. Both groups presented significant within-group improvements over time (both P < .001).

CONCLUSIONS

Combining noxious TS with traditional rehabilitation did not yield better short-term or long-term results than combining innocuous TS with traditional rehabilitation on UE functional recovery for individuals with acute stroke.

LEVEL OF EVIDENCE

II.

摘要

背景

热刺激(TS)已被开发并应用于中风康复。然而,有害和无害的 TS 是否对中风后运动功能恢复产生相同的影响尚不清楚。需要对不同温度组合方案进行比较研究。

目的

比较有害和无害 TS 对上肢运动恢复的短期和长期效果,以治疗急性中风患者。

设计

随机、对照试验,设隐匿分组,意向治疗分析和盲法结局评估。

地点

台湾一所大学医院康复科。

参与者

共纳入 79 例急性缺血性中风患者。大多数患者上肢(UE)存在中度至重度运动障碍。

干预

除了传统康复外,实验组(n = 39)接受有害 TS(热痛 46-47°C/冷痛 7-8°C),对照组(n = 40)接受无害 TS(热 40-41°C/冷 20-21°C)。TS 干预每天进行 30 分钟,住院期间共进行 20-24 次。使用定制的 TS 仪器,包括 2 个热刺激器及其各自的热垫,构建在闭环系统中。

结局

由盲法评估者在基线、第 12 次 TS 后、干预后、1 个月和 6 个月随访时进行 Fugl-Meyer 上肢评分(主要结局)、动作研究上肢测试、运动指数、巴氏指数和改良 Ashworth 量表(次要结局)。

结果

干预后和随访时,两组在主要结局上无显著差异。在 1 个月随访时,无害组的效果稍大(部分η=0.02),但 6 个月时该效果消失。两组均呈现随时间的显著组内改善(均 P <.001)。

结论

与传统康复相结合的有害 TS 治疗方案并未产生比与传统康复相结合的无害 TS 治疗方案更好的短期或长期效果,用于急性中风患者的 UE 功能恢复。

证据水平

II 级。

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