Standing up in multiple sclerosis (SUMS): A multi-centre randomised controlled trial evaluating the clinical and cost effectiveness of a home-based self-management standing frame programme in people with progressive multiple sclerosis

Background: Severely impaired people with progressive MS spend much of their day sitting. In response, secondary physical and psychosocial complications can occur. Effective self‐management strategies, feasible to implement within people's homes, are needed to improve/maintain mobility and its associated complications. This is challenging, particularly in the latter stages of disease. This study evaluates the use of a home‐based, self‐managed standing frame programme. Methods: A pragmatic, multi‐centre, definitive randomised controlled trial with blinded outcome assessments at baseline, 20 and 36 weeks post baseline and full economic evaluation. Those allocated to the intervention group were asked to stand for a minimum of 30 minutes three times weekly over 20 weeks. The primary clinical outcome was motor function (Amended Motor Club Assessment) and primary economic endpoint was quality‐adjusted life years. Participants recorded adherence to the standing programme in a diary, together with adverse events. Primary Analysis: Intention‐to‐treat approach, utilising analysis of covariance, comparing AMCA scores at week 36 between allocated groups, adjusting for baseline AMCA and stratification factors (baseline EDSS category, geographical region). Results: 140 people with progressive MS (mean [sd]: age 59.1 years [9.4], Expanded Disability Status Scale 7.3 [0.6]; 64% female, 69% secondary progressive, 71% daily wheelchair user) were recruited from eight centres, of whom 12 withdrew. Provisional analysis suggests that the adjusted AMCA at week 36 is statistically significantly higher in the standing frame group (n=61) compared to the control group (n=61) (adjusted betweengroup difference 4.7 [95% confidence interval 1.9 to 7.5]). Discussion: This is the first large scale multi‐centre trial to assess the clinical and cost effectiveness of a home based, self‐managed standing frame programme in people severely impaired by progressive MS. Our provisional results indicate that the standing frame intervention was feasible to implement and resulted in statistically significant benefits in motor function compared to usual care alone.