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对亚急性中风患者的患侧手进行每日重复性感觉刺激以治疗感觉运动功能障碍:RESET,一项随机、假对照试验。

Daily repetitive sensory stimulation of the paretic hand for the treatment of sensorimotor deficits in patients with subacute stroke: RESET, a randomized, sham-controlled trial.

作者信息

Kattenstroth Jan C, Kalisch Tobias, Sczesny-Kaiser Matthias, Greulich Wolfgang, Tegenthoff Martin, Dinse Hubert R

机构信息

Institute for Neuroinformatik, Neural Plasticity Lab, Ruhr-University of Bochum, Bochum, Germany.

Department of Neurology, University Hospital Bergmannsheil, Ruhr-University Bochum, Bochum, Germany.

出版信息

BMC Neurol. 2018 Jan 9;18(1):2. doi: 10.1186/s12883-017-1006-z.

DOI:10.1186/s12883-017-1006-z
PMID:29316895
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5759807/
Abstract

BACKGROUND

Repetitive sensory stimulation (RSS) adapts the timing of stimulation protocols used in cellular studies to induce synaptic plasticity. In healthy subjects, RSS leads to widespread sensorimotor cortical reorganization paralleled by improved sensorimotor behavior. Here, we investigated whether RSS reduces sensorimotor upper limb impairment in patients with subacute stroke more effectively than conventional therapy.

METHODS

A single-blinded sham-controlled clinical trial assessed the effectiveness of RSS in treating sensorimotor deficits of the upper limbs. Patients with subacute unilateral ischemic stroke were randomly assigned to receive standard therapy in combination with RSS or with sham RSS. Patients were masked to treatment allocation. RSS consisted of intermittent 20 Hz electrical stimulation applied on the affected hand for 45 min/day, 5 days per week, for 2 weeks, and was transmitted using custom-made stimulation-gloves with built-in electrodes contacting each fingertip separately. Before and after the intervention, we assessed light-touch and tactile discrimination, proprioception, dexterity, grip force, and subtasks of the Jebsen Taylor hand-function test for the non-affected and the affected hand. Data from these quantitative tests were combined into a total performance index serving as primary outcome measure. In addition, tolerability and side effects of RSS intervention were recorded.

RESULTS

Seventy one eligible patients were enrolled and randomly assigned to receive RSS treatment (n = 35) or sham RSS (n = 36). Data of 25 patients were not completed because they were transferred to another hospital, resulting in n = 23 for each group. Before treatment, sensorimotor performance between groups was balanced (p = 0.237). After 2 weeks of the intervention, patients in the group receiving standard therapy with RSS showed significantly better restored sensorimotor function than the control group (standardized mean difference 0.57; 95% CI -0.013-1.16; p = 0.027) RSS treatment was superior in all domains tested. Repetitive sensory stimulation was well tolerated and accepted, and no adverse events were observed.

CONCLUSIONS

Rehabilitation including RSS enhanced sensorimotor recovery more effectively than standard therapy alone. Rehabilitation outcome between the effects of RSS and standard therapy was largest for sensory and motor improvement; however, the results for proprioception and everyday tasks were encouraging warranting further studies in more severe patients.

TRIAL REGISTRATION

The trial was retrospectively registered January 31, 2012 under DRKS00003515 ( https://www.drks.de/drks_web/navigate.do;jsessionid=AEE2585CCB82A22A2B285470B37C47C8?navigationId=results ).

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5b55/5759807/f676a3b1a43b/12883_2017_1006_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5b55/5759807/f676a3b1a43b/12883_2017_1006_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5b55/5759807/f676a3b1a43b/12883_2017_1006_Fig1_HTML.jpg
摘要

背景

重复感觉刺激(RSS)可调整细胞研究中用于诱导突触可塑性的刺激方案的时间。在健康受试者中,RSS会导致广泛的感觉运动皮层重组,同时感觉运动行为得到改善。在此,我们研究了RSS是否比传统疗法更有效地减轻亚急性中风患者的感觉运动上肢损伤。

方法

一项单盲、假对照临床试验评估了RSS治疗上肢感觉运动缺陷的有效性。亚急性单侧缺血性中风患者被随机分配接受标准疗法联合RSS或假RSS治疗。患者对治疗分配情况不知情。RSS包括每天45分钟、每周5天、持续2周对患手施加间歇性20赫兹电刺激,并使用定制的带有分别接触每个指尖的内置电极的刺激手套进行传递。在干预前后,我们评估了非患手和患手的轻触觉、触觉辨别、本体感觉、灵活性、握力以及Jebsen Taylor手功能测试的子任务。这些定量测试的数据被合并为一个总体表现指数,作为主要结局指标。此外,记录了RSS干预的耐受性和副作用。

结果

71名符合条件的患者被纳入并随机分配接受RSS治疗(n = 35)或假RSS治疗(n = 36)。25名患者的数据未完成,因为他们被转至另一家医院,最终每组各有23名患者。治疗前,两组之间的感觉运动表现平衡(p = 0.237)。干预2周后,接受标准疗法联合RSS治疗的组患者的感觉运动功能恢复明显优于对照组(标准化均数差0.57;95% CI -0.013 - 1.16;p = 0.027)。RSS治疗在所有测试领域均更具优势。重复感觉刺激耐受性良好且被接受,未观察到不良事件。

结论

包括RSS的康复治疗比单纯标准疗法更有效地促进感觉运动恢复。RSS与标准疗法效果之间的康复结局在感觉和运动改善方面差异最大;然而,本体感觉和日常任务方面的结果令人鼓舞,值得在病情更严重的患者中进一步研究。

试验注册

该试验于2012年1月31日进行回顾性注册,注册号为DRKS00003515(https://www.drks.de/drks_web/navigate.do;jsessionid=AEE2585CCB82A22A2B285470B37C47C8?navigationId=results )。

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