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Balance Right in Multiple Sclerosis (BRiMS): preliminary results of a randomised controlled feasibility trial
Author(s): ,
J. Freeman
Affiliations:
School of Health Professions
,
H. Gunn
Affiliations:
School of Health Professions
,
J. Andrade
Affiliations:
School of Psychology, University of Plymouth, Plymouth
,
L. Paul
Affiliations:
Glasgow Caledonian University, Glasgow
,
L. Miller
Affiliations:
NHS Ayrshire and Arran, Irvine
,
K. Stevens
Affiliations:
Medical Statistics Group, Peninsula Schools of Medicine and Dentistry, Plymouth
,
C. Green
Affiliations:
Unversity of Exeter, Exeter
,
P. Ewings
Affiliations:
NIHR Research Design Service, Taunton
,
A. Barton
Affiliations:
NIHR Research Design Service
,
M. Berrow
Affiliations:
Peninsula Clinical Trials Unit, Peninsula Schools of Medicine and Dentistry, Plymouth
,
J. Vickery
Affiliations:
Peninsula Clinical Trials Unit, Peninsula Schools of Medicine and Dentistry, Plymouth
,
B. Marshall
Affiliations:
Service User, Cornwall, United Kingdom
,
J. Marsden
Affiliations:
School of Health Professions
S. Creanor
Affiliations:
Medical Statistics Group, Peninsula Schools of Medicine and Dentistry, Plymouth; Peninsula Clinical Trials Unit, Peninsula Schools of Medicine and Dentistry, Plymouth
ECTRIMS Online Library. Freeman J. Oct 12, 2018; 229111
Jennifer Freeman
Jennifer Freeman
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Abstract: P1271

Type: Poster Sessions

Abstract Category: Therapy - Symptomatic treatment

Purpose: Balance, mobility impairments and falls are common problems for people with 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/ encourage safer mobility. This study aimed to provide the necessary data to inform the conduct and design of a definitive trial.
Methods: Randomised controlled feasibility trial undertaken at four sites across the UK. Eligibility criteria included: diagnosis of secondary progressive MS, EDSS ≥4.0-≤7.0 and self-report of ≥ two falls in the preceding six months. Participants were randomised to BRiMS plus usual care or usual care alone. Assessments were scheduled at baseline, 15 and 27 weeks post-randomisation. Data included measures of feasibility, outcomes proposed for the anticipated definitive trial, measures of adherence and economic data. Telephone interviews with 13 participants and a therapist focus group (n=4) explored acceptability of the programme and trial procedures.
Results: Fifty-six participants (mean age 59.7 years [SD 9.7], 66% female, median EDSS 6.0 [IQR 6.0-6.5]) were recruited in five months; 30 were block randomised to the intervention group. The groups were broadly comparable at baseline, although there were differences in some baseline outcome measures. Ten (18%) participants withdrew, seven from the intervention group. Worsening of MS-related symptoms unconnected to the trial was the most common reason (n=5) for withdrawal. A total of 1215 falls were reported over the 27 week trial period, with substantial variation between individuals (range 0-459). Of these, 126 falls (8%) were reported as injurious. Other outcomes (including measures of mobility, balance and impact of MS) and economics data had completion rates greater than 98% for all those assessed.
Qualitative feedback indicated that trial processes and participant burden were acceptable, and participants highlighted both physical and behavioural changes that they perceived to result from undertaking BRiMS. Patterns of engagement varied, with a range of condition and context-related factors influencing this. Participants and therapists highlighted suggestions to improve the utility and accessibility of BRiMS.
Conclusions: Preliminary evaluation suggests that trial procedures are feasible and acceptable. Further development of BRiMS is required to address logistical issues and enhance user-satisfaction.
Disclosure: This study is funded by the NIHR Health Technology Assessment Programme (14/176/12), United Kingdom. This article presents independent research. The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health.

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