Balance Right in Multiple Sclerosis (BRiMS): a feasibility randomised controlled trial of a falls prevention programme

Abstract Background Balance, mobility impairments and falls are problematic for people with multiple sclerosis (MS). The “Balance Right in MS (BRiMS)” intervention, a 13-week home and group-based exercise and education programme, aims to improve balance and minimise falls. This study aimed to evaluate the feasibility of undertaking a multi-centre randomised controlled trial and to collect the necessary data to design a definitive trial. Methods This randomised controlled feasibility study recruited from four United Kingdom NHS clinical neurology services. Patients ≥ 18 years with secondary progressive MS (Expanded Disability Status Scale 4 to 7) reporting more than two falls in the preceding 6 months were recruited. Participants were block-randomised to either a manualised 13-week education and exercise programme (BRiMS) plus usual care, or usual care alone. Feasibility assessment evaluated recruitment and retention rates, adherence to group assignment and data completeness. Proposed outcomes for the definitive trial (including impact of MS, mobility, quality of life and falls) and economic data were collected at baseline, 13 and 27 weeks, and participants completed daily paper falls diaries. Results Fifty-six participants (mean age 59.7 years, 66% female, median EDSS 6.0) were recruited in 5 months; 30 randomised to the intervention group. Ten (18%) participants withdrew, 7 from the intervention group. Two additional participants were lost to follow up at the final assessment point. Completion rates were &gt; 98% for all outcomes apart from the falls diary (return rate 62%). After adjusting for baseline score, mean intervention—usual care between-group differences for the potential primary outcomes at week 27 were MS Walking Scale-12v2: − 7.7 (95% confidence interval [CI] − 17.2 to 1.8) and MS Impact Scale-29v2: physical 0.6 (CI − 7.8 to 9), psychological − 0.4 (CI − 9.9 to 9). In total, 715 falls were reported, rate ratio (intervention:usual care) for falls 0.81 (0.41 to 2.26) and injurious falls 0.44 (0.41 to 2.23). Conclusions Procedures were practical, and retention, programme engagement and outcome completion rates satisfied a priori progression criteria. Challenges were experienced in completion and return of daily falls diaries. Refinement of methods for reporting falls is therefore required, but we consider a full trial to be feasible. Trial registration ISRCTN13587999 Date of registration: 29 September 2016 </jats:sec

Performed and perceived walking ability in relation to the Expanded Disability Status Scale in persons with multiple sclerosis

Background: The severity of walking impairment in persons with multiple sclerosis (pwMS) at different levels on the expanded disability status scale (EDSS) is unclear. Furthermore, it is unclear if the EDSS is differently related to performed- and perceived walking capacity tests. Aims: To quantify walking impairment and perceived impact of MS on walking according to EDSS scores and to examine the relations between these parameters in pwMS. Methods: EDSS was collected by neurologists and walking was assessed by the timed 25 ft walk test (T25FWT), two minute walk test (2MWT), six minute walk test (6MWT) and the 12-item MS walking scale (MSWS-12) in 474 PwMS with mild (EDSS 1–4: n = 200) to moderate (EDSS 4.5–6.5: n = 274) MS. Magnitude of walking impairment was calculated and related to EDSS. Results: Compared to predicted values in healthy controls, walking speed was reduced by 41.5 ± 25.8% in the 6MWT for the total MS group and by 21.8 ± 20.2% and 55.8 ± 19.1% in the mild and moderate MS subgroups, respectively. The EDSS score showed the strongest relationship to the 2MWT and the 6MWT in the total MS group (r = −0.76, p < 0.0001), to the MSWS-12 score in the mild MS group (r = 0.56, p < 0.0001), and to the 2MWT in the moderate MS group (r = −0.50, p < 0.0001). Conclusion: In pwMS (EDSS scores 1–6.5), walking speed is on average reduced by ~40% when compared to predicted values in healthy controls, and impairments are already present at early disease stages, suggesting early initiation of rehabilitation. The 2MWT and 6MWT show the strongest relationship to EDSS, but the MSWS12 identify impairments more gradually at low EDSS scores.Coordination of this study was partially funded via a unrestricted educational grant from Novartis Pharma AG to the European RIMS network for best research and practice in MS rehabilitation. See www.euRIMS.org.multiple sclerosis; EDSS; walking impairment; walking measures; 6MWT; MSWS-1

Is the impact of fatigue related to walking capacity and perceived ability in persons with multiple sclerosis? A multicenter study

Background The relationship between fatigue impact and walking capacity and perceived ability in patients with multiple sclerosis (MS) is inconclusive in the existing literature. A better understanding might guide new treatment avenues for fatigue and/or walking capacity in patients with MS. Objective To investigate the relationship between the subjective impact of fatigue and objective walking capacity as well as subjective walking ability in MS patients. Methods A cross-sectional multicenter study design was applied. Ambulatory MS patients (n = 189, age: 47.6 ± 10.5 years; gender: 115/74 women/men; Expanded Disability Status Scale (EDSS): 4.1 ± 1.8 [range: 0–6.5]) were tested at 11 sites. Objective tests of walking capacity included short walking tests (Timed 25-Foot Walk (T25FW), 10-Metre Walk Test (10mWT) at usual and fastest speed and the timed up and go (TUG)), and long walking tests (2- and 6-Minute Walk Tests (MWT). Subjective walking ability was tested applying the Multiple Sclerosis Walking Scale-12 (MSWS-12). Fatigue impact was measured by the self-reported modified fatigue impact scale (MFIS) consisting of a total score (MFIStotal) and three subscales (MFISphysical, MFIScognitive and MFISpsychosocial). Uni- and multivariate regression analysis were performed to evaluate the relation between walking and fatigue impact. Results MFIStotal was negatively related with long (6MWT, r = −0.14, p = 0.05) and short composite (TUG, r = −0.22, p = 0.003) walking measures. MFISphysical showed a significant albeit weak relationship to walking speed in all walking capacity tests (r = −0.22 to −0.33, p < .0001), which persisted in the multivariate linear regression analysis. Subjective walking ability (MSWS-12) was related to MFIStotal (r = 0.49, p < 0.0001), as well as to all other subscales of MFIS (r = 0.24–0.63, p < 0.001), showing stronger relationships than objective measures of walking. Conclusions The physical impact of fatigue is weakly related to objective walking capacity, while general, physical, cognitive and psychosocial fatigue impact are weakly to moderately related to subjective walking ability, when analysed in a large heterogeneous sample of MS patients.All data-collecting centers (REVAL Rehabilitation Research Center, Diepenbeek (Belgium; n = 30 subjects); Rehabilitation and MS Center Overpelt, Overpelt (Belgium; n = 10); National MS Center, Melsbroek (Belgium; n = 17); Centre Neurologique et de Readaptation Fonctionelle, Fraiture-en-Condroz (Belgium; n = 16); Department of Rehabilitation, Third Faculty of Medicine, Charles University and Faculty Hospital Royal Vineyard (Czech Republic; n = 35); MS Centers of Haslev and Ry, Haslev and Ry (Denmark; n = 27); West-Tallinn Central Hospital, Tallinn (Estonia; n = 10); Masku Neurological Rehabilitation Center, Masku (Finland; n = 19); Hospital de Dia de Barcelona, Barcelona (Spain; n = 15); The Mellen Center for MS Treatment and Research, Cleveland (OH, USA; n = 10)) are thanked for their effort. Heiko Maamagi is acknowledged for his effort during the data-collection process. Domien Gijbels, who coordinated most of the data collection, is acknowledged for his effort during the study. KR thanks for grant support 260388/SVV/2017 and Progress Q35. Finally, the RIMS network (www.eurims.org) is acknowledged for facilitating inter European consultation and testing.Fatigue; Walking capacity; Multiple sclerosi