This trial is registered as ISRCTN13587999.
Funding
Funding for this study was provided by the Health Technology Assessment programme of the National Institute for Health Research.
Chapter 1
Introduction
Background
Multiple sclerosis (MS) is an incurable, unpredictable but typically progressive, life-long neurological condition, affecting approximately 100,000 people in the UK.1It is the most common cause of neurological disability
in young adults, with an estimated cost of £1.4B per annum to the NHS and society.2More recently, new
insights into the burden and costs of MS in Europe have demonstrated that, on average, costs are€22,800 in mild,€37,100 in moderate and€57,500 in severe disease (adjusted for purchasing power parity).3Although
most people start with a relapsing–remitting (RR) disease course, approximately two-thirds move to a progressive phase, with a gradual rise in the total percentage of progressive cases as the disease advances.4
At this point, medical interventions are limited and further disease progression is usually inevitable.5People in
this phase, the majority of whom have limited mobility, are often excluded from clinical trials, which tend to focus on the RR stage.6
Balance and falls in multiple sclerosis
Eighty-five per cent of people with MS report gait disturbance as their main problem.7Within approximately
15 years of diagnosis, 50% of people are unable to walk unaided, and over time an estimated 25% are dependent on a wheelchair.8It is, therefore, unsurprising that mobility is a major concern for people with
MS and the health professionals involved in their care, and an area that is consistently highlighted by research, policy and service user fora. Surveys of people with MS consistently rank mobility as their highest priority9and the most important, yet most challenging, daily function.10Furthermore, mobility has been
correlated with employment status, earnings and quality of life (QoL).11,12An important contributor to
difficulties in mobility is impaired balance, which is reported by approximately 75% of people with MS13and
has been shown to be more compromised in people with secondary progressive multiple sclerosis (SPMS) than in those with relapsing–remitting multiple sclerosis (RRMS).14Our own work suggests that falls may be
an early marker of mobility deterioration associated with disease progression.15Rehabilitation interventions
that improve balance and physical activity and decrease the risk of falls may slow this deterioration, providing a persuasive argument for ensuring that optimal physical management is a clinical priority. With only limited medical interventions available for this patient group, such rehabilitation programmes are considered key to the treatment of SPMS but currently lack a robust evidence base.5
Our research,16in line with that of others, demonstrates that, alongside impaired mobility and balance,
falls are a common issue for people with SPMS, who are twice as likely to fall as those with RRMS.17
The evidence shows that approximately 70% of people with MS fall regularly,15at a rate of > 26 falls per
person per year with SPMS.16More than 10% of these falls lead to injuries18and people with MS are three
times more likely to sustain a fracture than the general population.19Falling and fear of falling have a
profound impact on individuals, leading to activity curtailment, social isolation and a downwards spiral of immobility, deconditioning and disability accumulation.20This has significant implications for an individual’s
health, well-being and QoL. Unsurprisingly, 4 out of the 10 research priorities identified by the James Lind MS Priority Setting Partnership relate directly to this area.21This trial has provided an opportunity for
people with SPMS, whose limited mobility often excludes them from clinical trials, to participate in a trial targeting what they themselves consider to be a key concern.
Implications of impaired mobility and falls for society and for health practice
There are substantial economic and social costs related to increasing immobility, impaired balance and falls in people with MS. Costs of health and social care have been shown to increase steeply with increasing disease severity/immobility.2By this stage of the disease, rehabilitation interventions form the mainstay of
treatment and drug therapy options are limited. The mean cost per wheelchair-dependent patient is four to five times higher than that for an ambulatory patient.22This, together with the associated costs of falls
DOI: 10.3310/hta23270 HEALTH TECHNOLOGY ASSESSMENT 2019 VOL. 23 NO. 27
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for those who continue to ambulate, underlines the importance of optimising safe mobility for as long as possible: a key aim of our work. This is particularly relevant given recent evidence that people with MS are living longer, leading to a rising population living with the disease.23This has important implications for
resource provision in the UK and for the NHS, as highlighted in a national audit of neurological services,24
which demonstrated a significant increase in emergency hospital admissions in people with progressive neurological disability, including MS. The importance of mobility and falls is emphasised by their consistent prominence in recent policy documents for long-term neurological conditions.25
An overwhelming proportion of a physiotherapist’s MS caseload comprises people who have balance and mobility impairments, many of whom are falling. Improving balance and mobility in people with SPMS and reducing falls is likely to have a significant impact on QoL and independence. Our recent literature reviews, however, demonstrate that there is a lack of available evidence to support this assertion, although data from mixed samples of patients with RRMS or SPMS are suggestive.5,26Furthermore, professionals and patients
have identified serious problems with the feasibility and sustainability of a traditional weekly outpatient model of programme delivery.27The emphasis on evidence-based practice heavily influences whether or not
interventions are provided, as does local policy. These decisions rely on the availability of robust evidence of clinical effectiveness and cost-effectiveness. Currently, there is minimal evidence-based guidance to inform optimal mobility management and none to inform falls management in people with MS. This paucity of evidence is highlighted in the National Institute for Health and Care Excellence (NICE) clinical guideline 186,25
which nominates the rehabilitation of mobility as one of its five key research recommendations. Although evidence is available for older people and for other neurological conditions, research suggests that translating existing interventions to people with MS is likely to be ineffective.28,29Small, limited-duration
studies have evaluated single elements of MS balance and falls interventions, individually demonstrating short-term improvements in mobility, balance or falls awareness,13,30,31but these elements have not yet been
implemented or evaluated collectively. Moreover, no studies have focused on people with SPMS.