Skip to content

Research at St Andrews

A self-management programme to reduce falls and improve safe mobility in people with secondary progressive MS: the BRiMS feasibility RCT

Research output: Contribution to journalArticle


Open Access permissions



Hilary Gunn, Jackie Andrade, Lorna Paul, Linda Miller, Siobhan Creanor, Kara Stevens, Colin Green, Paul Ewings, Andrew Barton, Margie Berrow, Jane Vickery, Ben Marshall, John Peter Zajicek, Jennifer Freeman

School/Research organisations


BACKGROUND: Balance, mobility impairments and falls are common problems for people with multiple sclerosis (MS). Our ongoing research has led to the development of Balance Right in MS (BRiMS), a 13-week home- and group-based exercise and education programme intended to improve balance and encourage safer mobility. OBJECTIVE:This feasibility trial aimed to obtain the necessary data and operational experience to finalise the planning of a future definitive multicentre randomised controlled trial. DESIGN:Randomised controlled feasibility trial. Participants were block randomised 1 : 1. Researcher-blinded assessments were scheduled at baseline and at 15 and 27 weeks post randomisation. As is appropriate in a feasibility trial, statistical analyses were descriptive rather than involving formal/inferential comparisons. The qualitative elements utilised template analysis as the chosen analytical framework. SETTING:Four sites across the UK. PARTICIPANTS:Eligibility criteria included having a diagnosis of secondary progressive MS, an Expanded Disability Status Scale (EDSS) score of between ≥ 4.0 and ≤ 7.0 points and a self-report of two or more falls in the preceding 6 months. INTERVENTIONS:Intervention - manualised 13-week education and exercise programme (BRiMS) plus usual care. Comparator - usual care alone. MAIN OUTCOME MEASURES:Trial feasibility, proposed outcomes for the definitive trial (including impact of MS, mobility, quality of life and falls), feasibility of the BRiMS programme (via process evaluation) and economic data. RESULTS:A total of 56 participants (mean age 59.7 years, standard deviation 9.7 years; 66% female; median EDSS score of 6.0 points, interquartile range 6.0-6.5 points) were recruited in 5 months; 30 were block randomised to the intervention group. The demographic and clinical data were broadly comparable at baseline; however, the intervention group scored worse on the majority of baseline outcome measures. Eleven participants (19.6%) withdrew or were lost to follow-up. Worsening of MS-related symptoms unrelated to the trial was the most common reason (n = 5) for withdrawal. Potential primary and secondary outcomes and economic data had completion rates of > 98% for all those assessed. However, the overall return rate for the patient-reported falls diary was 62%. After adjusting for baseline score, the differences between the groups (intervention compared with usual care) at week 27 for the potential primary outcomes were MS Walking Scale (12-item) version 2 -7.7 [95% confidence interval (CI) -17.2 to 1.8], MS Impact Scale (29-item) version 2 (MSIS-29vs2) physical 0.6 (95% CI -7.8 to 9) and MSIS-29vs2 psychological -0.4 (95% CI -9.9 to 9) (negative score indicates improvement). After the removal of one outlier, a total of 715 falls were self-reported over the 27-week trial period, with substantial variation between individuals (range 0-93 falls). Of these 715 falls, 101 (14%) were reported as injurious. Qualitative feedback indicated that trial processes and participant burden were acceptable, and participants highlighted physical and behavioural changes that they perceived to result from undertaking BRiMS. Engagement varied, influenced by a range of condition- and context-related factors. Suggestions to improve the utility and accessibility of BRiMS were highlighted. CONCLUSIONS:The results suggest that the trial procedures are feasible and acceptable, and retention, programme engagement and outcome completion rates were sufficient to satisfy the a priori progression criteria. Challenges were experienced in some areas of data collection, such as completion of daily diaries. FUTURE WORK:Further development of BRiMS is required to address logistical issues and enhance user-satisfaction and adherence. Following this, a definitive trial to assess the clinical effectiveness and cost-effectiveness of the BRiMS intervention is warranted.


Original languageEnglish
Pages (from-to)1-166
JournalHealth Technology Assessment
Issue number27
Publication statusPublished - 1 Jun 2019

Discover related content
Find related publications, people, projects and more using interactive charts.

View graph of relations

Related by author

  1. Simvastatin as a neuroprotective treatment for Parkinson's disease (PD STAT): protocol for a double-blind, randomised, placebo-controlled futility study

    Carroll, C. B., Webb, D., Stevens, K. N., Vickery, J., Eyre, V., Ball, S., Wyse, R., Webber, M., Foggo, A., Zajicek, J., Whone, A. & Creanor, S., 7 Oct 2019, In : BMJ Open. 9, 10, 11 p., e029740.

    Research output: Contribution to journalArticle

  2. Assessment of a home-based standing frame programme in people with progressive multiple sclerosis (SUMS): a pragmatic, multi-centre, randomised, controlled trial and cost-effectiveness analysis

    Freeman, J. A., Hendrie, W., Jarrett, L., Hawton, A., Barton, A., Dennett, R., Jones, B., Zajicek, J. P. & Creanor, S., 1 Aug 2019, In : Lancet Neurology. 18, 8, p. 736-747

    Research output: Contribution to journalArticle

  3. Machine-learning based identification of undiagnosed dementia in primary care: a feasibility study

    Jammeh, E. A., Carroll, C. B., Pearson, S. W., Escudero, J., Anastasiou, A., Zhao, P., Chenore, T., Zajicek, J. & Ifeachor, E., 12 Jun 2018, In : BJGP Open. 2, 2, 13 p., bjgpopen18X101589.

    Research output: Contribution to journalArticle

  4. Improving the quality of cognitive screening assessments: ACEmobile, an iPad-based version of the Addenbrooke's Cognitive Examination-III

    Newman, C. G. J., Bevins, A. D., Zajicek, J. P., Hodges, J. R., Vuillermoz, E., Dickenson, J. M., Kelly, D. S., Brown, S. & Noad, R. F., 2018, In : Alzheimer's & Dementia: Diagnosis, Assessment & Disease Monitoring. 10, p. 182-187 6 p.

    Research output: Contribution to journalArticle

  5. 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 secondary progressive multiple sclerosis: a protocol for a feasibility randomised controlled trial

    Gunn, H., Andrade, J., Paul, L., Miller, L., Creanor, S., Green, C., Marsden, J., Ewings, P., Berrow, M., Vickery, J., Barton, A., Marshall, B., Zajicek, J. & Freeman, J. A., 27 Jul 2017, In : Pilot and Feasibility Studies. 4, 12 p., 26.

    Research output: Contribution to journalArticle

Related by journal

  1. What works to increase attendance for diabetic retinopathy screening? An evidence synthesis and economic analysis

    Lawrenson, J. G., Graham-Rowe, E., Lorencatto, F., Rice, S., Bunce, C., Francis, J. J., Burr, J. M., Aluko, P., Vale, L., Peto, T., Presseau, J., Ivers, N. M. & Grimshaw, J. M., Jun 2018, In : Health Technology Assessment. 22, 29, 160 p.

    Research output: Contribution to journalArticle

  2. Modifying Alcohol Consumption to Reduce Obesity (MACRO): development and feasibility trial of a complex community-based intervention for men

    Crombie, I., Cunningham, K., Irvine, L., Williams, B., Sniehotta, F. F., Norrie, J., Melson, A., Jones, C., Briggs, A., Rice, P., Achison, M., McKenzie, A., Dimova, E. & Slane, P. W., Apr 2017, In : Health Technology Assessment. 21, 19, 149 p.

    Research output: Contribution to journalArticle

  3. The use of fibrin sealant during non-emergency surgery: a systematic review of the evidence of benefits and harms

    Edwards, S. J., Crawford, F., van Velthoven, M. H., Berardi, A., Osei-Assibey, G., Bacelar, M., Salih, F. & Wakefield, V., Jan 2017, In : Health Technology Assessment. 20, 94, 252 p.

    Research output: Contribution to journalReview article

  4. A randomised placebo-controlled trial of oral and topical antibiotics for children with clinically infected eczema in the community: the ChildRen with Eczema, Antibiotic Management (CREAM) study

    Francis, N. A., Ridd, M. J., Thomas-Jones, E., Shepherd, V., Butler, C. C., Hood, K., Huang, C., Addison, K., Longo, M., Marwick, C., Wootton, M., Howe, R., Roberts, A., Haq, M. I., Madhok, V., Sullivan, F. & CREAM team, Mar 2016, In : Health Technology Assessment. 20, 19, p. i-xxiv, 1-84

    Research output: Contribution to journalArticle

ID: 263135904