Abstract
BackgroundBalance, 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.MethodsThis 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.ResultsFifty-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).ConclusionsProcedures 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.Trial registrationISRCTN13587999Date of registration: 29 September 2016
Highlights
Balance, mobility impairments and falls are problematic for people with multiple sclerosis (MS)
(iii)What are the implications of the feasibility findings on the design of the main study? The findings indicate that a large-scale trial is feasible; refinement of falls reporting methods and development of Balance Right in MS (BRiMS) programme delivery methods are recommended prior to progressing further
Recruitment Of the 232 subjects screened over 5 months, 44 declined and a further 20 were deemed ineligible on screening, leaving 56 consented participants
Summary
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. Multiple sclerosis (MS) is an incurable, unpredictable but typically progressive, life-long, neurological condition, affecting approximately 100,000 people in the UK (UK) [1]. It is the most common cause of neurological disability in young adults. Rehabilitation interventions which improve balance and mobility, and decrease the risk of falls, may slow this deterioration, providing a persuasive argument for ensuring this should be a clinical priority
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