Study protocol of a randomized controlled trial comparing backward walking to forward walking training on balance in multiple sclerosis: The TRAIN-MS trial

IF 2 3区 医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Contemporary clinical trials Pub Date : 2024-07-05 DOI:10.1016/j.cct.2024.107621
{"title":"Study protocol of a randomized controlled trial comparing backward walking to forward walking training on balance in multiple sclerosis: The TRAIN-MS trial","authors":"","doi":"10.1016/j.cct.2024.107621","DOIUrl":null,"url":null,"abstract":"<div><p>Balance impairment and accidental falls are a pervasive challenge faced by persons with multiple sclerosis (PwMS), significantly impacting their quality of life. While exercise has proven to be an effective intervention for improving mobility and functioning in PwMS, current exercise approaches predominantly emphasize forward walking (FW) and balance training, with variable improvements in balance and fall rates. Backward walking (BW) has emerged as a promising intervention modality for enhancing mobility and strength outcomes; however, significant gaps remain. Specifically, there is limited knowledge about the efficacy of BW interventions on outcomes such as static, anticipatory, and reactive balance, balance confidence, falls, and cognition. This randomized controlled trial aims to determine the feasibility, acceptability, and impact of 8-weeks of backward walking training (TRAIN-BW) as compared to forward walking training (TRAIN-FW). Ninety individuals with MS with self-reported walking dysfunction or ≥ 2 falls in the past 6 months will be randomized in blocks, stratified by sex and disease severity to either the TRAIN-BW or TRAIN-FW intervention groups. Adherence and retention rates will be used to determine feasibility and the Client Satisfaction Questionnaire will be used to assess acceptability. The primary outcomes will be static, anticipatory, and reactive balance. Secondary outcomes include walking velocity, balance confidence, concern about falling, cognition, physical activity, and fall rates measured prospectively for 6 months after post-testing. Additionally, the extent to which cognitive functioning influences response to intervention will be examined. Backward walking training may be an innovative intervention to address balance impairments and falls in persons with MS.</p></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":null,"pages":null},"PeriodicalIF":2.0000,"publicationDate":"2024-07-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Contemporary clinical trials","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S1551714424002040","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}
引用次数: 0

Abstract

Balance impairment and accidental falls are a pervasive challenge faced by persons with multiple sclerosis (PwMS), significantly impacting their quality of life. While exercise has proven to be an effective intervention for improving mobility and functioning in PwMS, current exercise approaches predominantly emphasize forward walking (FW) and balance training, with variable improvements in balance and fall rates. Backward walking (BW) has emerged as a promising intervention modality for enhancing mobility and strength outcomes; however, significant gaps remain. Specifically, there is limited knowledge about the efficacy of BW interventions on outcomes such as static, anticipatory, and reactive balance, balance confidence, falls, and cognition. This randomized controlled trial aims to determine the feasibility, acceptability, and impact of 8-weeks of backward walking training (TRAIN-BW) as compared to forward walking training (TRAIN-FW). Ninety individuals with MS with self-reported walking dysfunction or ≥ 2 falls in the past 6 months will be randomized in blocks, stratified by sex and disease severity to either the TRAIN-BW or TRAIN-FW intervention groups. Adherence and retention rates will be used to determine feasibility and the Client Satisfaction Questionnaire will be used to assess acceptability. The primary outcomes will be static, anticipatory, and reactive balance. Secondary outcomes include walking velocity, balance confidence, concern about falling, cognition, physical activity, and fall rates measured prospectively for 6 months after post-testing. Additionally, the extent to which cognitive functioning influences response to intervention will be examined. Backward walking training may be an innovative intervention to address balance impairments and falls in persons with MS.

查看原文
分享 分享
微信好友 朋友圈 QQ好友 复制链接
本刊更多论文
一项随机对照试验的研究方案,比较后向行走和前向行走训练对多发性硬化症患者平衡能力的影响:TRAIN-MS 试验。
平衡障碍和意外跌倒是多发性硬化症患者(PwMS)普遍面临的挑战,严重影响了他们的生活质量。虽然运动已被证明是改善多发性硬化症患者行动能力和功能的有效干预措施,但目前的运动方法主要强调向前行走(FW)和平衡训练,对平衡和跌倒率的改善效果不一。后退步行(BW)已成为一种很有前景的干预方式,可提高行动能力和力量成果;但仍存在很大差距。具体来说,人们对倒走干预在静态、预期和反应平衡、平衡信心、跌倒和认知等方面的效果了解有限。这项随机对照试验旨在确定为期 8 周的后向步行训练(TRAIN-BW)与前向步行训练(TRAIN-FW)相比的可行性、可接受性和影响。90名自述行走功能障碍或在过去6个月中≥2次跌倒的多发性硬化症患者将按性别和疾病严重程度随机分入TRAIN-BW或TRAIN-FW干预组。坚持率和保留率将用于确定可行性,客户满意度问卷将用于评估可接受性。主要结果包括静态平衡、预期平衡和反应平衡。次要结果包括行走速度、对平衡的信心、对跌倒的担忧、认知能力、体育锻炼以及在测试后 6 个月内的跌倒率。此外,还将研究认知功能对干预反应的影响程度。后退行走训练可能是解决多发性硬化症患者平衡障碍和跌倒问题的创新干预措施。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
求助全文
约1分钟内获得全文 去求助
来源期刊
CiteScore
3.70
自引率
4.50%
发文量
281
审稿时长
44 days
期刊介绍: Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.
期刊最新文献
Design and implementation of a Type-2 hybrid, prospective randomized trial of opioid agonist therapies integration into primary care clinics in Ukraine The clinical and cost effectiveness of internet-delivered self-help Acceptance and Commitment Therapy for family carers of people with dementia (iACT4CARERS): Study protocol for a randomised controlled trial with ethnically diverse family carers Editorial Board Enhancing clinical drug trial monitoring with blockchain technology Methods to characterize lactate turnover in aging and Alzheimer's disease; The LEAN study
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
现在去查看 取消
×
提示
确定
0
微信
客服QQ
Book学术公众号 扫码关注我们
反馈
×
意见反馈
请填写您的意见或建议
请填写您的手机或邮箱
已复制链接
已复制链接
快去分享给好友吧!
我知道了
×
扫码分享
扫码分享
Book学术官方微信
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术
文献互助 智能选刊 最新文献 互助须知 联系我们:info@booksci.cn
Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。
Copyright © 2023 Book学术 All rights reserved.
ghs 京公网安备 11010802042870号 京ICP备2023020795号-1