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自我指导的手臂曲柄运动以改善亚急性脊髓损伤患者躯干的意志控制:一项多中心、平行组、随机对照试验方案

Self-directed arm-crank exercise to improve volitional control of the trunk in patients with subacute spinal cord injury: a multicentre, parallel-group, randomised controlled trial protocol.

作者信息

Hidalgo Mas Maria Del Rocio, Kearney Joshua, Middleton Vicki, Chiu Chuang-Yuan, Duda Joan L, Nightingale Tom E, Martinez-Valdes Eduardo, Ahmed Zubair, Chiou Shin-Yi

机构信息

School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham, Birmingham, UK.

Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK.

出版信息

BMJ Open. 2025 Aug 21;15(8):e092226. doi: 10.1136/bmjopen-2024-092226.

Abstract

INTRODUCTION

A spinal cord injury (SCI) disrupts synaptic connections between the corticospinal tract and motor neurons, impairing muscle control below the injury site. Many individuals with an SCI have impaired trunk control, affecting the performance of activities of daily living and quality of life. Work has shown improvements in trunk control after home-based, unsupervised arm-crank exercise training (ACET) in people with chronic motor-incomplete SCI. However, no studies have examined ACET's impact on trunk control in individuals with subacute SCI. This study aims to investigate ACET's effects on trunk control in adults with subacute incomplete SCI, and its mechanisms, and its long-term benefits on neuropathic pain, psychological well-being, physical activity levels and health-related quality of life.

METHODS AND ANALYSIS

This multicentre, parallel-group, randomised controlled trial will evaluate self-directed ACET in 60 individuals with subacute SCI (<6 months postinjury). All participants will receive standard in-patient rehabilitation; the intervention group will additionally undertake a progressive ACET protocol for 8 weeks. Assessments will occur at baseline (T0), 4 weeks (T1), postintervention (T2) and 6-month follow-up (T3). Outcomes include static and dynamic sitting balance with kinematic measurements and high-density electromyography of the erector spinae, corticospinal excitability, muscle strength, functional independence and questionnaires of neuropathic pain, psychological well-being, self-efficacy and motivation, physical activity and health-related quality of life. Quantitative data will be analysed using mixed-model repeated measures ANOVAs and Student's t-tests. Thematic analysis will be conducted on qualitative data obtained from focus groups in which the feasibility, enablers and challenges of ACET for individuals with subacute SCI will be discussed.

ETHICS AND DISSEMINATION

This study was approved by The Health Research Authority and Health and Care Research Wales (22/NS/0054). Results will be published in peer-reviewed journals. Findings will be presented at National and International conferences for researchers and clinicians. Finally, results will be disseminated to the SCI community.

TRIAL REGISTRATION NUMBER

ISRCTN17247972.

摘要

引言

脊髓损伤(SCI)会破坏皮质脊髓束与运动神经元之间的突触连接,损害损伤部位以下的肌肉控制。许多脊髓损伤患者的躯干控制能力受损,影响日常生活活动表现和生活质量。研究表明,慢性运动不完全性脊髓损伤患者在进行家庭自主、无人监督的手臂曲柄运动训练(ACET)后,躯干控制能力有所改善。然而,尚无研究探讨ACET对亚急性脊髓损伤患者躯干控制的影响。本研究旨在调查ACET对亚急性不完全性脊髓损伤成人患者躯干控制的影响、其作用机制,以及对神经性疼痛、心理健康、身体活动水平和健康相关生活质量的长期益处。

方法与分析

本多中心、平行组、随机对照试验将评估60例亚急性脊髓损伤(受伤后<6个月)患者进行的自主ACET。所有参与者将接受标准的住院康复治疗;干预组还将进行为期8周的渐进性ACET方案。评估将在基线(T0)、4周(T1)、干预后(T2)和6个月随访(T3)时进行。结果包括通过运动学测量和竖脊肌高密度肌电图评估的静态和动态坐位平衡、皮质脊髓兴奋性、肌肉力量、功能独立性,以及关于神经性疼痛、心理健康、自我效能感和动机、身体活动和健康相关生活质量的问卷调查。定量数据将使用混合模型重复测量方差分析和学生t检验进行分析。将对焦点小组获得的定性数据进行主题分析,讨论ACET对亚急性脊髓损伤患者的可行性、促进因素和挑战。

伦理与传播

本研究已获得健康研究管理局和威尔士卫生与护理研究机构批准(22/NS/0054)。结果将发表在同行评审期刊上。研究结果将在面向研究人员和临床医生的国家和国际会议上展示。最后,研究结果将传播给脊髓损伤群体。

试验注册号

ISRCTN17247972。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/842d/12374656/a1b46500cda8/bmjopen-15-8-g001.jpg

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