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

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. TRIAL REGISTRATION: Current Controlled Trials ISRCTN13587999. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 27. See the NIHR Journals Library website for further project information.

People with secondary progressive multiple sclerosis (SPMS) often have problems with walking and balance, which lead them to fall. Undertaking exercise and learning about falls prevention could help reduce injury risk and improve mobility. We developed a mobility, balance and falls programme called Balance Right in MS (BRiMS). Before testing its effectiveness in a large-scale trial, we needed to conduct a small-scale version of the trial. We asked people with SPMS who had balance and mobility problems to be assigned by chance to undertake the BRiMS programme plus their usual care, or to continue with usual care only. Questionnaires were used to ask people about their mobility, falls and quality of life, and we measured their balance and activity levels. We interviewed participants about BRiMS and being in the trial, and collected information about costs. Fifty-six people entered the trial from three areas of the south-west and from Ayrshire. At completion of the study we were able to review 44 people. The key measures were completed by 98% of those we assessed, but only around half (62%) of the diaries detailing falls were returned. As this was a feasibility trial, the numbers were too small for us to look at differences between the groups. Participants liked the BRiMS programme; some did a lot of exercise and learning activities, but most did not manage the amount we asked them to do. People reported feeling a little overwhelmed by the educational content of BRiMS, and that this should be reduced in future. They told us that they felt that their balance had improved and that they fell less frequently after the BRiMS programme. Our assessment of the trial methods we used showed that it would be possible to conduct a full-scale trial using this design, but that we need to adapt the BRiMS programme further to make it more user-friendly.

Does the use of Nintendo Wii SportsTM improve arm function? Trial of WiiTM in Stroke: a randomized controlled trial and economics analysis.

OBJECTIVE: The Trial of Wii™ in Stroke investigated the efficacy of using the Nintendo Wii Sports™ (WiiTM) to improve affected arm function after stroke. DESIGN: Multicentre, pragmatic, parallel group, randomized controlled trial. SETTING: Home-based rehabilitation. SUBJECTS: A total of 240 participants aged 24-90 years with arm weakness following a stroke within the previous six months. INTERVENTION: Participants were randomly assigned to exercise daily for six weeks using the WiiTM or arm exercises at home. MAIN MEASURES: Primary outcome was change in the affected arm function at six weeks follow-up using the Action Research Arm Test. Secondary outcomes included occupational performance, quality of life, arm function at six months and a cost effectiveness analysis. RESULTS: The study was completed by 209 participants (87.1%). There was no significant difference in the primary outcome of affected arm function at six weeks follow-up (mean difference -1.7, 95% CI -3.9 to 0.5, p = 0.12) and no significant difference in secondary outcomes, including occupational performance, quality of life or arm function at six months, between the two groups. No serious adverse events related to the study treatment were reported. The cost effectiveness analysis showed that the WiiTM was more expensive than arm exercises £1106 (SD 1656) vs. £730 (SD 829) (probability 0.866). CONCLUSION: The trial showed that the WiiTM was not superior to arm exercises in home-based rehabilitation for stroke survivors with arm weakness. The WiiTM was well tolerated but more expensive than arm exercises.

Does the use of Nintendo Wii Sports™ improve arm function and is it acceptable to patients after stroke? Publication of the Protocol of the Trial of Wii™ in Stroke - TWIST.

INTRODUCTION: Many stroke patients experience loss of arm function requiring rehabilitation, which is expensive, repetitive, and does not always translate into "real life." Nintendo Wii Sports™ (Wii™) may offer task-specific training that is repetitive and motivating. The Trial of Wii™ in Stroke (TWIST) is designed to investigate feasibility, efficacy, and acceptability using Wii™ to improve affected arm function for patients after stroke. METHOD: This is a randomized controlled trial (RCT), incorporating a qualitative study and health economics analysis that compares playing Wii™ versus arm exercises in patients receiving standard rehabilitation in a home setting within 6 months of stroke with a motor deficit of less than 5 on the MRC (Medical Research Council) scale (arm). In this study, we expect to randomize 240 participants. OUTCOME MEASURES: Primary outcome is change in affected arm function at 6 weeks follow-up in intervention and control group using the Action Research Arm Test. Secondary outcomes include occupational performance using the Canadian Occupational Performance Measure, quality of life using the Stroke Impact Scale, cost effectiveness analysis, and a qualitative study investigating factors that influence use of Wii™ for patients and carers. CONCLUSION: TWIST is the first UK RCT assessing the feasibility, cost effectiveness, and acceptability of Wii™ in stroke rehabilitation. The trial has been registered with ISRCTN 06807619 and UK CRN 11030. Results of the study will be published after completion of study in August 2014.