Title: A multi-centre randomised controlled trial to assess the effectiveness and cost effectiveness of a home-based self-management standing frame programme in people with progressive MS
Funder: Department of Health and Social Care

Abstract: Background MS is an incurable, unpredictable, progressive, life-long, challenging neurological condition that impacts on every part of a person s life. Affecting approximately 100,000 people in the UK, it is the most common cause of neurological disability in young adults, with diagnosis occurring on average at around age thirty. Within 15 years of diagnosis, approximately 50% of people cannot walk without assistance1 and, over time, 25% are dependent on a wheelchair2. At this stage, balance is usually precarious and most people spend the majority of their day sitting down. This immobility has been shown to lead to secondary complications (e.g. pain, pressure areas, muscle wasting, constipation and psychosocial problems such as depression and isolation) which complicate care and delay rehabilitation. The associated high costs are widely acknowledged, both in economic and quality of life terms. Increasing physical activity can minimise these problems, however this is difficult when disability is severe. Usual physiotherapy comprises short intermittent episodes of face-to-face intervention; long-term maintenance therapy is limited due to resource restrictions. Regular supported standing using frames is a self-management option, with some data to support its acceptability, feasibility and efficacy in people severely impaired with progressive MS, both as part of a short3 and longer term4 home-based, health maintenance programme. More robust evidence is required as the studies to date are limited in number and methodological rigor5. Study Aims: We aim to:- 1) Assess the clinical and cost effectiveness of a home-based standing frame programme in improving motor function and quality of life in people severely impaired by progressive MS; 2) Assess the effectiveness of the standing frame intervention in improving balance, muscle strength, joint and muscle range, spasms, respiratory, bladder and bowel function and number of falls; 3) Explore the subjective experience of using a standing frame within the home as part of daily life from the perspective of people with MS and their carers. Study Design and Methods: A pragmatic multi-centred randomised controlled trial with blinded outcome assessment will be adopted. 140 people severely impaired with progressive MS will be recruited from two English regions; Devon/Cornwall and East Anglia. Participants will be randomised to either a home-based standing self-management programme along with their usual care (intervention) or usual care alone (control). Intervention participants will receive two home-based, one-hour therapy sessions, followed by 6 telephone consultations (~15 minutes/call), supported by user-friendly information leaflets and DVD s. They will be encouraged to stand in the frame for 30 minutes, three times per week, over the 20 week period. Throughout this time the Control group will receive &ldquo;usual care&rdquo;. In both groups outcomes will be measured at baseline, immediately post-intervention (20 weeks) and at follow-up (16 weeks post-intervention i.e. week 36). Outcomes include: motor function, lower limb muscle and joint range and muscle strength, balance, spasms, respiratory, bladder/bowel function and quality of life. These will be measured using clinically oriented, validated measures. A full economic evaluation will assess the cost effectiveness of this standing programme. The subjective experiences of using a standing frame within the home as part of daily life will be explored qualitatively in a sub-group of 10 intervention participants and 10 carers. This study will provide scientifically robust results regarding the standing frame intervention. If shown to be clinically and cost effective, the evidence provided will be suitable for development of recommendations for a health service delivery model which could be implemented across the UK. Recommendations would include guidance on implementation costs, evaluation tools for monitoring safety, tolerability and effectiveness, and the role of carers. It would provide clinicians and service users with clear guidance for the use of this self-management strategy.

Lay abstract: Standing upright is highly valued by most individuals, both psychologically (e.g. enabling eye to eye interaction) and physiologically (e.g. maintaining muscle strength). Standing frames are commonly used by people with spinal cord injury (SCI) who are unable to stand unaided. These frames provide support to enable even severely disabled patients to stand safely. Regular use has been shown to minimise the physical complications arising from prolonged immobility and increase feelings of well-being. Like those with SCI, many people with severe Multiple Sclerosis (MS) cannot stand independently, often developing disabling complications as a result of immobility. Two pilot studies have demonstrated that such people can obtain similar benefits to those with SCI by using a standing frame. However, in many areas frames are not issued due to limited scientific evidence. This study will provide robust evidence about their efficacy. Many people with MS develop severe walking problems and consequently spend much of their day sitting down. The associated secondary problems (e.g. pressure sores, contractures, muscle wasting) impact on quality of life and result in increased healthcare needs. These problems can be minimised if physical activity is increased. However, without easy access to a frame people must travel to a rehabilitation/MS centre to stand, often incurring expensive travel costs. Using a standing frame at home may offer a solution which reduces the economic and social costs for the patient and NHS. Our study involves 140 severely physically impaired people with MS. Participants will be randomly allocated to either a home-based, self-management standing programme (with advice and support) along with their usual care or to usual care alone. Participants will be asked to stand 3 times weekly over 20 weeks. A range of outcomes, including motor function and balance, will be measured at intervals throughout the study and compared between the two groups.

Research activity codes: 7.1 INDIVIDUAL CARE NEEDS
Health categories: NEUROLOGICAL