脊髓损伤患者的早期和强化运动训练（SCI-MT 试验）：过程评估方案。

Early and Intensive Motor Training for people with spinal cord injuries (the SCI-MT Trial): protocol of the process evaluation.

机构信息

Kolling Institute, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.

John Walsh Centre for Rehabilitation Research, Northern Sydney Local Health District, St Leonards, New South Wales, Australia.

出版信息

BMJ Open. 2023 Aug 29;13(8):e072219. doi: 10.1136/bmjopen-2023-072219.

DOI:10.1136/bmjopen-2023-072219

PMID:37643854

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10465915/

Abstract

INTRODUCTION

People with spinal cord injury receive physical rehabilitation to promote neurological recovery. Physical rehabilitation commences as soon as possible when a person is medically stable. One key component of physical rehabilitation is motor training. There is initial evidence to suggest that motor training can enhance neurological recovery if it is provided soon after injury and in a high dosage. The Early and Intensive Motor Training Trial is a pragmatic randomised controlled trial to determine whether 10 weeks of intensive motor training enhances neurological recovery for people with spinal cord injury. This pragmatic randomised controlled trial will recruit 220 participants from 15 spinal injury units in Australia, Scotland, Italy, Norway, England, Belgium and the Netherlands. This protocol paper describes the process evaluation that will run alongside the Early and Intensive Motor Training Trial. This process evaluation will help to explain the trial results and explore the potential facilitators and barriers to the possible future rollout of the trial intervention.

METHODS AND ANALYSIS

The UK Medical Research Council process evaluation framework and the Implementation Research Logic Model will be used to explain the trial outcomes and inform future implementation. Key components of the context, implementation and mechanism of impact, as well as the essential elements of the intervention and outcomes, will be identified and analysed. Qualitative and quantitative data will be collected and triangulated with the results of the Early and Intensive Motor Training Trial to strengthen the findings of this process evaluation.

ETHICS AND DISSEMINATION

Ethical approval for the Early and Intensive Motor Training Trial and process evaluation has been obtained from the Human Research Ethics Committee at the Northern Sydney Local Health District (New South Wales) in Australia (project identifier: 2020/ETH02540). All participants are required to provide written consent after being informed about the trial and the process evaluation. The results of this process evaluation will be published in peer-reviewed journals.

TRIAL REGISTRATION NUMBER

Australian New Zealand Clinical Trial Registry (ACTRN12621000091808); Universal Trial Number (U1111-1264-1689).

摘要

简介

脊髓损伤患者接受物理康复治疗以促进神经恢复。当患者身体状况稳定后，应尽快开始物理康复。物理康复的一个关键组成部分是运动训练。有初步证据表明，如果在损伤后尽快且高剂量地提供运动训练，可增强神经恢复。早期和强化运动训练试验是一项实用的随机对照试验，旨在确定 10 周的强化运动训练是否能增强脊髓损伤患者的神经恢复。这项实用的随机对照试验将从澳大利亚、苏格兰、意大利、挪威、英格兰、比利时和荷兰的 15 个脊髓损伤单位招募 220 名参与者。本方案文件描述了将与早期和强化运动训练试验同时进行的过程评估。这项过程评估将有助于解释试验结果，并探讨试验干预措施未来可能推广的促进因素和障碍。