Gunn H, Stevens K N, Creanor S, Andrade J, Paul L, Miller L, Green C, Ewings P, Barton A, Berrow M, Vickery J, Marshall B, Zajicek J, Freeman J A
Faculty of Health, School of Health Professions, Peninsula Allied Health Centre, University of Plymouth, Derriford Road, Plymouth, PL6 8BH, England.
Faculty of Health, Medical Statistics Group, Room N15, Plymouth Science Park, Plymouth, PL6 8BX, England.
Pilot Feasibility Stud. 2021 Jan 4;7(1):2. doi: 10.1186/s40814-020-00732-9.
Balance, mobility impairments and falls are problematic for people with multiple sclerosis (MS). The "Balance Right in MS (BRiMS)" intervention, a 13-week home and group-based exercise and education programme, aims to improve balance and minimise falls. This study aimed to evaluate the feasibility of undertaking a multi-centre randomised controlled trial and to collect the necessary data to design a definitive trial.
This randomised controlled feasibility study recruited from four United Kingdom NHS clinical neurology services. Patients ≥ 18 years with secondary progressive MS (Expanded Disability Status Scale 4 to 7) reporting more than two falls in the preceding 6 months were recruited. Participants were block-randomised to either a manualised 13-week education and exercise programme (BRiMS) plus usual care, or usual care alone. Feasibility assessment evaluated recruitment and retention rates, adherence to group assignment and data completeness. Proposed outcomes for the definitive trial (including impact of MS, mobility, quality of life and falls) and economic data were collected at baseline, 13 and 27 weeks, and participants completed daily paper falls diaries.
Fifty-six participants (mean age 59.7 years, 66% female, median EDSS 6.0) were recruited in 5 months; 30 randomised to the intervention group. Ten (18%) participants withdrew, 7 from the intervention group. Two additional participants were lost to follow up at the final assessment point. Completion rates were > 98% for all outcomes apart from the falls diary (return rate 62%). After adjusting for baseline score, mean intervention-usual care between-group differences for the potential primary outcomes at week 27 were MS Walking Scale-12v2: - 7.7 (95% confidence interval [CI] - 17.2 to 1.8) and MS Impact Scale-29v2: physical 0.6 (CI - 7.8 to 9), psychological - 0.4 (CI - 9.9 to 9). In total, 715 falls were reported, rate ratio (intervention:usual care) for falls 0.81 (0.41 to 2.26) and injurious falls 0.44 (0.41 to 2.23).
Procedures were practical, and retention, programme engagement and outcome completion rates satisfied a priori progression criteria. Challenges were experienced in completion and return of daily falls diaries. Refinement of methods for reporting falls is therefore required, but we consider a full trial to be feasible.
ISRCTN13587999 Date of registration: 29 September 2016.
平衡能力、行动能力受损以及跌倒对于多发性硬化症（MS）患者而言是个难题。“MS平衡康复计划（BRiMS）”干预措施是一项为期13周的家庭及小组式运动与教育项目，旨在改善平衡能力并尽量减少跌倒。本研究旨在评估开展一项多中心随机对照试验的可行性，并收集必要数据以设计一项确定性试验。
这项随机对照可行性研究从英国国民健康服务体系（NHS）的四个临床神经科服务机构招募患者。招募年龄≥18岁、患有继发进展型MS（扩展残疾状态量表评分为4至7）且报告在过去6个月内跌倒超过两次的患者。参与者被整群随机分为两组，一组接受为期13周的标准化教育与运动项目（BRiMS）加常规护理，另一组仅接受常规护理。可行性评估包括招募和保留率、对分组分配的依从性以及数据完整性。在基线、第13周和第27周收集确定性试验的拟议结果（包括MS的影响、行动能力、生活质量和跌倒情况）以及经济数据，参与者需完成每日纸质跌倒日记。
在5个月内招募了56名参与者（平均年龄59.7岁，66%为女性，EDSS中位数为6.0）；30名被随机分配至干预组。10名（18%）参与者退出，其中7名来自干预组。在最终评估点，另有2名参与者失访。除跌倒日记外（回收率62%），所有结果的完成率均>98%。在对基线分数进行调整后，第27周时两组间潜在主要结果的平均干预组与常规护理组差异为：MS步行量表 - 12v2：-7.7（95%置信区间[CI] - 17.2至1.8），MS影响量表 - 29v2：身体方面0.6（CI - 7.8至9），心理方面 - 0.4（CI - 9.9至9）。总共报告了715次跌倒，跌倒的率比（干预组：常规护理组）为0.81（0.41至2.26），受伤跌倒的率比为0.44（0.41至2.23）。
研究程序切实可行，保留率、项目参与度和结果完成率均满足预先设定的进展标准。在每日跌倒日记的完成和回收方面遇到了挑战。因此需要改进跌倒报告方法，但我们认为全面试验是可行的。
ISRCTN13587999 注册日期：2016年9月29日。
