Gunn H, Andrade J, Paul L, Miller L, Creanor S, Green C, Marsden J, Ewings P, Berrow M, Vickery J, Barton A, Marshall B, Zajicek J, Freeman J A
Faculty of Health and Human Sciences, School of Health Professions, Plymouth University, Peninsula Allied Health Centre, Derriford Rd, Plymouth, PL6 8BH UK.
Faculty of Health and Human Sciences, School of Psychology, Portland Square Building, Drake Circus Campus, Plymouth, PL4 8AA UK.
Pilot Feasibility Stud. 2017 Jul 27;4:26. doi: 10.1186/s40814-017-0168-1. eCollection 2018.
Impaired mobility is a cardinal feature of multiple sclerosis (MS) and is rated by people with MS as their highest priority. By the secondary progressive phase, balance, mobility and physical activity levels are significantly compromised; an estimated 70% of people with secondary progressive MS fall regularly. Our ongoing research has systematically developed 'Balance Right in MS' (BRiMS), an innovative, manualised 13-week guided self-management programme tailored to the needs of people with MS, designed to improve safe mobility and minimise falls. Our eventual aim is to assess the clinical and cost effectiveness of BRiMS in people with secondary progressive MS by undertaking an appropriately statistically powered, multi-centre, assessor-blinded definitive, randomised controlled trial. This feasibility study will assess the acceptability of the intervention and test the achievability of running such a definitive trial.
METHODS/DESIGN: This is a pragmatic multi-centre feasibility randomised controlled trial with blinded outcome assessment. Sixty ambulant people with secondary progressive MS who self-report two or more falls in the previous 6 months will be randomly allocated (1:1) to either the BRiMS programme plus usual care or to usual care alone. All participants will be assessed at baseline and followed up at 15 weeks and 27 weeks post-randomisation. The outcomes of this feasibility trial include:Feasibility outcomes, including trial recruitment, retention and completionAssessment of the proposed outcome measures for the anticipated definitive trial (including measures of walking, quality of life, falls, balance and activity level)Measures of adherence to the BRiMS programmeData to inform the economic evaluation in a future trialProcess evaluation (assessment of treatment fidelity and qualitative evaluation of participant and treating therapist experience).
The BRiMS intervention aims to address a key concern for MS service users and providers. However, there are several uncertainties which need to be addressed prior to progressing to a full-scale trial, including acceptability of the BRiMS intervention and practicality of the trial procedures. This feasibility trial will provide important insights to resolve these uncertainties and will enable a protocol to be finalised for use in the definitive trial.
ISRCTN13587999.
行动能力受损是多发性硬化症（MS）的主要特征，MS患者将其列为最需优先解决的问题。到继发进展期，平衡能力、行动能力和身体活动水平会受到严重影响；据估计，70%的继发进展型MS患者会经常跌倒。我们正在进行的研究系统地开发了“MS平衡有道”（BRiMS），这是一项创新的、手册化的为期13周的自我管理指导计划，针对MS患者的需求量身定制，旨在改善安全行动能力并尽量减少跌倒。我们最终的目标是通过开展一项具有适当统计学效力、多中心、评估者盲法的确定性随机对照试验，评估BRiMS对继发进展型MS患者的临床和成本效益。这项可行性研究将评估干预措施的可接受性，并测试开展此类确定性试验的可行性。
方法/设计：这是一项实用的多中心可行性随机对照试验，采用盲法评估结果。60名能够行走的继发进展型MS患者，若自我报告在过去6个月内跌倒过两次或更多次，将被随机分配（1:1）至BRiMS计划加常规护理组或仅常规护理组。所有参与者将在基线时接受评估，并在随机分组后的第15周和第27周进行随访。这项可行性试验的结果包括：
可行性结果，包括试验招募、留存率和完成情况
对预期确定性试验的拟议结果测量指标的评估（包括行走、生活质量、跌倒、平衡和活动水平的测量指标）
BRiMS计划的依从性测量指标
为未来试验的经济评估提供信息的数据
过程评估（治疗保真度评估以及对参与者和治疗师体验的定性评估）。
BRiMS干预旨在解决MS服务使用者和提供者的一个关键问题。然而，在开展全面试验之前，有几个不确定因素需要解决，包括BRiMS干预的可接受性和试验程序的实用性。这项可行性试验将为解决这些不确定因素提供重要见解，并将使用于确定性试验的方案最终确定。
ISRCTN13587999
