中国神经再生研究(英文版)

中国神经再生研究(英文版) ›› 2023, Vol. 18 ›› Issue (4): 819-824.doi: 10.4103/1673-5374.353507

• 原著:脊髓损伤修复保护与再生 • 上一篇    下一篇

脊髓损伤硬膜外电刺激治疗后肌电诱导康复的安全及有效性：前瞻性、单中心、随机、对照、临床试验方案

  

  • 出版日期:2023-04-15 发布日期:2022-10-29
  • 基金资助:
    上海市卫生健康委员会(普通项目，202140221)，上海市临床重点专科(shslczdzk02701)。

Safety and effectiveness of electromyography-induced rehabilitation treatment after epidural electrical stimulation for spinal cord injury: study protocol for a prospective, randomized, controlled trial

Xiao-Pei Sun1, 2, #, Jie-Jian Shi2, #, Yong Bao1, 2, *, Jie Zhang2, Hui-Juan Pan2, Dian-You Li1, Yu Liang1, Qing Xie1, *   

  1. 1Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China; 2Shanghai Ruijin Rehabilitation Hospital, Shanghai, China
  • Online:2023-04-15 Published:2022-10-29
  • Contact: Yong Bao, MS, yongbao1001@163.com; Qing Xie, MS, ruijin_xq@163.com.
  • Supported by:
    This study was supported by a grant from Shanghai Municipal Health Commission (General Program), No. 202140221 (to YB); Shanghai Municipal Key Clinical Specialty , No. shslczdzk02701.

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摘要：

硬膜外电刺激是一种脊髓损伤治疗的新手段，且其有效性及安全性已有研究报道。脊髓损伤硬膜外电刺激术后的康复治疗，是保证并提高该患者术后疗效的重要手段。考虑到肌电诱发的康复治疗可以准确匹配患者的肌肉收缩，故课题组设计了一项前瞻性随机对照试验方案，以脊髓损伤后接受硬膜外电刺激治疗的患者为研究对象，在调节脊髓电刺激器获得目标肌肉最大肌电信号的前提下，进行肌电诱导康复训练，并观察其关键肌的肌力恢复、生活质量、安全性和疗效的变化。收集上海市瑞金康复医院进行脊髓损伤硬膜外电刺激手术后的患者20例，随机分为2组，对照组10例进行常规康复训练；肌电诱导康复组10例在常规康复训练的基础上进行上肢和下肢关键肌的肌电诱导康复训练。康复训练干预后随访2周、1，3，6个月。主要结局指标为采用徒手肌力评定量表评价患者关键肌的肌力恢复情况；次要结局指标为改良Barthel指数量表评分、积分肌电参数、目测类比评分、脊髓损伤独立能力评估量表评分和改良Ashworth痉挛量表评分；安全性指标为不良事件发生率。该研究将持续收集肌电诱导康复训练对接受硬膜外电刺激治疗的脊髓损伤患者在干预后6个月治疗效果的随访证据，从而有助于优化制定脊髓损伤电刺激术后康复模式。临床试验方案已经中国上海市瑞金康复医院伦理委员会审批，伦理批准号：RKIRB2022-12，批准时间：2022-02-15。试验已经在中国临床试验注册中心注册(注册号：ChiCTR2200061674，注册时间：2022-07-30)，方案版本号：1.0。

https://orcid.org/0000-0002-5639-872X (Yong Bao); https://orcid.org/0000-0002-3298-1072 (Qing Xie)

关键词: 硬膜外电刺激, 脊髓损伤, 肌电诱导康复, 康复, 肌力, 生活质量, 疼痛, 随机对照试验

Abstract: Epidural electrical stimulation is a new treatment method for spinal cord injury (SCI). Its efficacy and safety have previously been reported. Rehabilitation treatment after epidural electrical stimulation is important to ensure and improve the postoperative efficacy of epidural electrical stimulation in patients with SCI. Considering that electromyography (EMG)-induced rehabilitation treatment can accurately match the muscle contraction of patients with SCI, we designed a study protocol for a prospective, randomized controlled trial. In this trial, on the premise of adjusting the spinal cord electrical stimulator to obtain the maximum EMG signal of the target muscle, patients with SCI receiving epidural electrical stimulation will undergo EMG-induced rehabilitation treatment. Recovery of muscle strength of key muscles, quality of life, safety and therapeutic effects will be monitored. Twenty patients with SCI who are scheduled to undergo epidural electrical stimulation in Shanghai Ruijin Rehabilitation Hospital will be randomly divided into two groups with 10 patients per group. The control group will receive conventional rehabilitation treatment. The EMG-induced rehabilitation group will receive EMG-induced rehabilitation treatment of the target muscles of the upper and lower limbs based on conventional rehabilitation treatment. After rehabilitation treatment, follow up for all patients will occur at 2 weeks and 1, 3 and 6 months. The primary outcome measure of this trial will be evaluation of target muscle recovery using the Manual Muscle Testing grading scale. Secondary outcome measures will include modified Barthel Index scores, integrated EMG values, the visual analogue scale, Spinal Cord Independence Measure scores, and modified Ashworth scale scores. The safety indicator will be the incidence of adverse events. This trial will collect data regarding the therapeutic effects of EMG-induced rehabilitation in patients with SCI receiving epidural electrical stimulation for 6 months after rehabilitation treatment. Findings from this trial will help develop rehabilitation methods in patients with SCI after epidural electrical stimulation. This study protocol was approved by Ethics Committee of Shanghai Ruijin Rehabilitation Hospital (Approval No. RKIRB2022-12) on February 15, 2022 and was registered with Chinese Clinical Trial Registry (registration number: ChiCTR2200061674; date: June 30, 2022). Study protocol version: 1.0.  

Key words: electromyography-induced rehabilitation, epidural electrical stimulation, muscle strength, pain, quality of life, randomized controlled trial, recovery, spinal cord injury