Title: Balance Right in Multiple Sclerosis (BRiMS): A guided self-management programme to reduce falls and improve quality of life, balance and mobility in people with Multiple Sclerosis.
Funder: Department of Health and Social Care

Abstract: Background: Impaired mobility is a cardinal feature of Multiple Sclerosis (MS) and is rated by people with MS (pwMS) as their highest priority. By the secondary progressive phase (SPMS), balance, mobility and physical activity levels are significantly compromised; an estimated 70% of people with SPMS (pwSPMS) fall regularly. In the absence of effective disease-modifying drugs, rehabilitation interventions are key. Our ongoing research has systematically developed ‘Balance Right in MS’ (BRiMS), an innovative, manualised 13 week self-management programme tailored to the needs of pwMS, designed to improve safe mobility and minimise falls. It is now critical to assess the programme’s feasibility and proposed evaluation methods prior to a definitive RCT. Aims:Our eventual aim is to assess the clinical and cost effectiveness of BRiMS in pwSPMS by undertaking a powered, multi-centre, assessor-blinded RCT. However uncertainties exist about the optimal parameters for a definitive trial. This feasibility study will provide the necessary data to inform the conduct and finalise the design of a definitive trial. We will test the feasibility of running such a trial, providing estimates of: recruitment; attrition; concordance; baseline scores, standard deviations and completion rates of the measures. We will assess the acceptability of the intervention and of participating in the trial from the participant and health professional perspective, and the process of delivering BRiMS, to finalise a protocol for use in the definitive trial. Methods: We propose a pragmatic multi-centre feasibility RCT with blinded outcome assessment. Sixty ambulant pwSPMS who self-report two or more falls in the past six months will be recruited via national and regional MS registers, NHS clinician caseloads, MS Society/MS Trust newsletters, social networking sites, and MS Society branches. This will test the recruitment strategy for the definitive trial. In this feasibility study sampling will be from two regions (Devon/Cornwall; Ayrshire, Scotland). Eligible participants will undertake a baseline assessment will be undertaken using clinician-rated and patient self-reported measures: QoL, mobility, physical activity levels, falls frequency/injury, fear of falling, motor function, balance and community integration. Participants will then be randomised (1:1) via a web-based system to BRiMS plus usual care (Intervention) or usual clinical care (Control). Intervention participants will participate in two individual and three pre-scheduled group sessions (n~5 per group) addressing physical, behavioural and environmental aspects of mobility and falls management; supplemented by a tailored home based package delivered via a web-based interactive resource. Control participants will receive usual care, which is variable, typically comprising a written exercise programme.The measures will be repeated at 13 weeks (end of intervention) and again at 25 weeks (12 weeks post-intervention). Programme concordance and health related resource use will be determined through questionnaires. BRiMS sessions will be audio-recorded to rate intervention fidelity for a random 25% of sessions, using a Fidelity Checklist. Qualitative work will explore participant and staff experiences, acceptability and utility of BRiMS and willingness to be randomised (patients) or to recruit participants (clinicians). Results will be presented for a feasibility study, primarily to aid planning of the definitive RCT.

Lay abstract: The ability to walk safely, free of falls and fear of falling, is highly valued by people with multiple sclerosis (pwMS) since it impacts directly on their quality of life, productivity and independence. This is challenging for those in the secondary progressive phase, since most people experience significant difficulties with balance and mobility, with approximately 70% falling regularly (26 falls/per person/year). It is therefore unsurprising that interventions aimed at enhancing safe mobility are consistently rated by pwMS as their highest priority. The economic cost of impaired mobility and falls is significant. More than 10% of falls lead to injuries, which impacts on emergency hospital admissions and health and social care services. People lose confidence in their own abilities if they are fearful of falling and many further restrict their daily activities to minimise falls which may cause social isolation and a downward spiral of increasing immobility and accumulation of disability. Effective rehabilitation interventions which aim to address these issues are crucial since medical interventions are limited in their ability to slow down this deterioration. Currently however there is no evidence-based guidance to inform falls management in people with secondary progressive MS, since there are few relevant studies. Over the past five years we have undertaken a series of inter-related research studies which have focused on systematically developing a new evidence-based intervention which is designed to improve safe mobility and reduce falls for pwMS. This programme is called ‘Balance Right in MS’ (BRiMS). Throughout, we have worked very closely with pwMS and health professionals working in this area, so that the programme has relevance to their needs, is practical to implement, and sustainable in terms of NHS service delivery. We have also worked closely with researchers from around the world to ensure the programme is based on the latest available evidence and scientific thinking in this area. Of importance, this is a self management programme, designed to be incorporated into people’s daily lives. It is now critical to assess the delivery of this programme and how to evaluate it. We do not yet know enough to design and undertake a large scale clinical trial and so are conducting first a smaller feasibility study. This will be undertaken in two regions (Devon/Cornwall and Ayrshire) and involve 60 people with secondary progressive MS who have mobility and balance difficulties and who are falling. Participants will be randomly allocated to either the BRiMS programme plus usual care, or usual care alone. Those allocated to the BRiMS intervention will attend a 13 week-therapy led education and exercise programme, comprising three group sessions, two individual sessions and a home based package which will be delivered via an existing interactive web resource. We will measure a wide range of outcomes including quality of life, number of falls, balance, mobility and people's fear of falling, so that we can gain a better understanding of how these outcomes may change. We will also gain an understanding of how many people are suitable for this programme, and their experiences of participating in this study. This is necessary to allow us to proceed more confidently in the future with a larger multi-centre randomised controlled trial which will provide definitive evidence of the effectiveness and cost effectiveness of this programme.

Research activity codes: 3.2 INTERVENTIONS TO ALTER PHYSICAL AND BIOLOGICAL ENVIRONMENTAL RISKS;6.7 PHYSICAL
Health categories: NEUROLOGICAL