Hilary Gunn - Falls in MS: managing complexity and complications

Falls in MS: managing complexity
and complications
Hilary Gunn

Falls in MS- workshop plan
Why do people fall?
What can we do about it?
Our experiences- practicalities and learning
Future opportunities
H Gunn University of Plymouth MS Trust November 2018

Falls in MS
Incidence of falls ranges from 52 to 63%
A significant number of individuals experience multiple falls
Falls are associated with increased risk of injury (HR 4.08 (95%CI 2.21-
7.56)).
Fear of falling (63.5%) and associated activity curtailment (82.6%) is
common
(Peterson 2007, Nilsagard 2007, Bazelier 2012, Gunn 2015)

Complex and complicated?
Complex: consisting of many
different and connected parts.
Complicated: made up of
intricate parts or aspects that
are difficult to understand or
analyse.

Why do people with MS fall?

Falls in MS… a complex problem
Fall risk
Mechanistic Humanistic Contextual

Fall risk
Mechanistic/
physiological

Complexity of falls: ‘disease severity’
Nilsagard 2014

Looking beneath the ‘headlines’: Impairments
in MS and falls risk
Fallers worse than non fallers in all measures,
however:
• Urinary continence issues: OR 2.77 (1.4-5.4)
Spasticity:
Ashworth 1: OR 7.88 (2.16 to 28.8)
Ashworth 2+: OR 2.51 (0.91 to 6.95)
‘Balance’ as measured by the PPA…

Physiological Profile Assessment

Fall risk
Humanistic/
Psychological

Complexity of falls: Relationship of psychological
and physiological risk factors
Gunn et al 2018

Complexity of falls: Relationship of walking
aids and falls in MS
Coote 2013
Unimpaired Mobility Impaired mobility
Aid No Aid Aid No Aid
Also Peterson 2013: Multiple walking aid use and fall
attribution (OR = 3.78, 95% CI =2.09-6.85)

Fall risk
Contextual

Contextual issues

Falls in MS… a complex complicated problem
Fall risk
Mechanistic Humanistic Contextual

Addressing falls in MS….

Addressing falls in MS- opportunities
Humanistic/ contextual:
Awareness of risks and causes of falls
Identify personal attitudes/ behaviours that may be significant
Falls prevention strategies
Planning and falls management
Mechanistic:
Identify and manage specific symptoms that may be an issue
Exercise:
Improve balance/ mobility
Address specific impairments
Reduce risk of falls/ ability to regain balance

Falls management in MS- a complex intervention
MRC definition of a ‘complex intervention’
Takes place in a naturalistic setting
Several:
Components
Behaviours
Possible outcomes
Levels of the healthcare system
Heterogeneous population
Almost always needs tailoring Craig et al 2008

Evidence in MS- physical interventions…
Gunn et al 2015

Evidence- behavioural interventions
Outcomes
Awareness of falls risks
Development of falls management strategies
Confidence to avoid a fall
?? Impact on falls risk/ rate??
Finlayson2009

Our programme and trial

Our ‘complex’ falls intervention: BRiMS
EXERCISE EDUCATION
Goal setting and motivational support

13 week programme
Supportive self-management ethos:
Strong home focus,
Supported by:
Therapist input,
Online/ paper resources and
Periodic group elements
Our ‘complex’ falls intervention: BRiMS

BRiMS trial
Feasibility study n=60 (recruited in blocks of 8-12)
Inclusion criteria:
• Secondary progressive MS
• EDSS ≥ 4.0 ≤ 7.0
• Self-report ≥ 2 falls in the past six months
• Access to a computer or tablet and to the internet.

Outcome group Outcome measure
Trial feasibility Recruitment and retention, safety and adverse events
Feasibility and
performance of:
Potential Primary
Outcomes
MSWS-12 vs2.0
EuroQoL EQ5D-5L
MS Impact Scale-29 vs2.0
Potential
Secondary
Outcomes
Falls frequency and injury rates
Physical Activity (ActivPAL)
2 minute walk test
Mini BEST
Functional reach- forward and lateral
FES-i
Community Participation Indicators
Process Evaluation
Attendance and engagement data
Session fidelity assessment
Participant telephone interviews
Treating Therapist focus group

BRiMS Process evaluation
BRiMS
Process
evaluation
Participant
interviews
Therapist
focus group
Fidelity
assessment
Trial
outcome
measures
Trial
recordsa
Website
usage data
Participant
diary
returns

BRiMS exercise elements
EXERCISE EDUCATION

MS falls prevention- exercise interventions
likely to need to achieve…
❌

So, how did we address this?
Aims of the BRiMS Exercise programme
Implementation of a challenging targeted programme of gait and balance
training will increase mobility and decrease falls
The BRiMS exercise package will enable participants to progress their
exercises and become increasingly self-directed
Group exercise sessions will provide feedback and encourage progression/
support motivation/ enhance adherence/ engagement
The introduction of exercise activity substitution will support people to
adapt the programme to maintain long-term adherence
Succeeding in balance training will increase the individual’s confidence in
balance and safe mobility , and enhance function/ participation

So, how did we do it?
BRiMS Exercise programme
Exercise menu- Choice of exercises for therapists to select from
Six activity categories- aiming to achieve 120 minutes practise each
week
Sit- stand
activities
Stepping
activities
Standing
balance
Walking Reaching
Height
changes

Delivery of exercise elements

Simple ways to increase challenge…

Specificity: making exercise count…
Target specific issues….
• Make use of existing (free)
resources…

Duration: Supporting engagement
The input needs to be given in such a way that we enjoy it; we remember it or we
have prompts to remember it, and we go away and we do it. So that is, whether
it’s a group or individual, those rules must apply because the only way it’s going
to work is with the time, motivation and energy that we find to put into it.
NG3MS16 Verbal comment (Gunn et al 2018)

Results: Implementation of exercise elements
Source Data
Therapist contact
sheets
Therapists carried out 142 online reviews of exercise
programmes (average 5 per participant)
Therapist focus
group
T1: 'I thought the web-based exercises were wonderful, I thought
they were a really brilliant resource’
T3: I think from the BRiMS exercise menu if it tied up more easily
with the [online] site that would be more helpful
Adverse event
data
No serious adverse event reports related to participation in
programme activitiesH Gunn University of Plymouth MS Trust November 2018

N (%) Weeks attempted 12 Weeks
Exercise time per week (minutes)
Mean (SD) 78.2 (70.8) 48.9 (44.7)
Median (LQ - UQ) 68.4 (21.3 - 119.3) 35.5 (8.4 - 96.3)
[min - max] [0 - 357] [0 - 126.6]
Mean exercise per week (minutes) n (%)
At least 120 6 (22.2) 3 (11.1)
100 - 119 4 (14.8) 3 (11.1)
80 - 99 2 (7.4)
60 - 79 4 (14.8) 1 (3.7)
40-59 3 (11.1) 3 (11.1)

Source Data
Participant
interviews
P8: One of the good things is that it is very flexible, so if you wanted to do
it anytime in the day you could do it….You put the person in the control and
that’s a very good feeling as well as opposed to ‘you must show up on
Monday morning at nine o’clock to do this’. Whatever day you were having
you chose the time to do it.
“I didn’t use that so much, no I didn’t no”.
P: “The therapist gave me a paper print out and she showed me the
exercises.. when she visited, so I had all of those and that’s what I used.…I
was able to do it far better than I would have been trying to watch a video.
It just doesn’t work for me, I’m sure it works for most, well lots of people, but
it doesn’t, I need to have it there and be able to keep looking at it.”H Gunn University of Plymouth MS Trust November 2018

Results: independent practice/ progression
Source Data
Participant/
therapist
interviews
P5: I never got back. So I think it would have been much better to start with
just a few small things, build up. My exercises were never changed so I
never felt I was progressing.
T2: They seemed to feel quite confident with experimenting a little bit with
their exercise without having to refer back to the video, and with that came
the fact that they weren’t logging in so much and because they weren’t
logging in so much they then weren’t logging how much exercise they were
doing. So even though they were telling me via emails that they were
exercising, and when they came back to the class they were exercising,
actually I couldn’t witness that on the web-based logins.

Outcomes: exercise/ balance/ falls
P4: I’m just really pleased that I was on the programme. The exercises have all
helped…… Unbelievably because you know turning my head and not getting
dizzy and going over, that, I mean it just amazed me that such a simple thing
and doing it regularly worked. … I was very surprised in a really good way over
that.
P13: So I definitely think it has helped and the exercises that you do are
tailored for you anyway, so I thought it was becoming apparent, it was visual
to me when I was filling in the diaries. That I was, I was improving, my balance
was improving and even a little improvement can have a huge impact you
know because you are a little bit more confident

Outcomes: falls
Falls Injurious Falls
BRiMS
(N = 30)
Usual Care
(N = 25)
BRiMS
(N = 30)
Usual Care
(N = 25)
Rate (falls PPY) 21.9 27.0 2.2 4.9
Rate Ratio (95%
Confidence Interval)
0.81 (0.41 to 2.26) 0.44 (0.41 to 2.23)

Variable Time point
Difference between allocated groups (BRiMS + usual care – usual care)
Mean (95% CI)
Unadjusted Adjusted
2MWT
Baseline
Wk 15 1.4 (-15 to 17.9) 0.3 (-9.4 to 10)
Wk 27 -1.3 (-19.9 to 17.2) -2.2 (-14.6 to 10.2)
MiniBEST
Baseline
Wk 15 1.7 (-1.9 to 5.3) 2.6 (-0.1 to 5.4)
Wk 27 0.5 (-3.2 to 4.2) 1.2 (-1.2 to 3.6)
Forward FRT
Baseline
Wk 15 4.7 (0.6 to 8.8) 2.7 (-0.3 to 5.7)
Wk 27 2.5 (-1.9 to 6.9) 1 (-2.7 to 4.6)
Mobility/ Balance outcomes

BRiMS education elements
EXERCISE EDUCATION

Aims of BRiMS education programme
The BRiMS home packages and group sessions will support
participants to identify their personal fall risk factors
Developing individual plans to reduce fall risk factors will enable
participants to modify activities to improve safe mobility and will
improve confidence/ self-efficacy
Identifying barriers and facilitators for fall prevention plan enactment
will support long term adoption of the plans

BRiMS education activities
• Approaches
• Goal setting and (self) monitoring
• Engendering a supported self-
management approach
• Supporting peer interaction and
learning

Delivery of education elements

Education activities- examples
• Falls stories
• Fall photos
• Individual and Peer learning
• Self-assessment activities- Environment, symptom management etc- with
signposting/ discussion
• Action planning and review

Engagement with online education activities
Education package log in and completion rate
Total number of logins
Median (LQ – UQ) 5 (4 - 13)
[Min – Max] [0 - 85]
Completion rates N (%)
 Home package 1 (week 1) 16 (53.3)
 Home package 2 (weeks 2-4) 12 (40.0)
 Home package 3 (weeks 5-8) 9 (30.0)
 Home package 4 (weeks 9-13) 7 (23.3)H Gunn University of Plymouth MS Trust November 2018

Attendance at group sessions
Group N % randomised
1 (Week 4) 23 76.7
2 (Week 8) 10 33.3
3 (Week 13) 13 43.3

Education activities
P9: there was a big booklet the yellow pages, I think. I couldn’t begin
by reading all that stuff, there were too many words and too
complicated.
P5: I found the [education] exercises… but then I’m an ex primary
school teacher, we did them with primary school children. I did find
that difficult to do exercises like that.
P13: There were parts of the manual I really thought were important
in there for me and those were the bits that were throwing things
back at you ‘what about this and how do you do this and do you feel
about that’ and I thought ‘I should know that’, but actually writing it
down… ‘oh I did this today’, kind of ‘how was it for you’?

Experiences: Group sessions
Participant interview:
But yeah it was good because it’s always good in a group, you get so much
from other people, so actually doing the exercises and discussing where we
were with parts of the project
Therapist Focus Group:
T2: they all really liked seeing what each other was up to, and they got lots
of good ideas about what each other was doing,
T1: what really surprised me was how hard the previous [group] non-
attender had worked at home because she really thought she was going to
be the one that was furthest behind and really she was furthest ahead
because she had committed so much to the online diary

Process evaluation: Impact of education activities
P8: It makes you more aware. So that’s another positive aspect of it. It makes
you more responsible about what’s going on around you. I can’t just rely on
[my husband] all the time. I have to look after myself as well.
P11: And I have learnt so much from it, about, towards deciding I’d do my
housework on a one day, one room basis. I’ve split it up. I’ve learnt a lot of
things that I wouldn’t have done- you know when I was at work I had to do it
at weekends because now I have split it up I only do what I can do.
I: Having taken part, have made any changes as a result of doing that? Has it
made any impact for you? … P7: No it hasn’t.

Education activities: confidence
Variable Time point
Difference between allocated groups (BRiMS + usual care – usual care)
Mean (95% CI)
Unadjusted Adjusted
FESi
Baseline
Wk 15 -4.2 (-9.4 to 1) -5.1 (-9.8 to -0.4)
Wk 27 -2.9 (-9.2 to 3.4) -3.7 (-8.8 to 1.4)

Goal setting and motivation
EXERCISE EDUCATION

Motivational support
Goal setting
Feedback and progress review
Functional imagery training

Therapist feedback
T1: I think that’s where my skills very quickly ran out because I didn’t
have the, um, background to then be able to counsel them into a
more positive attitude; I think on the whole I felt I needed more help
to present the imagery

So… our findings so far….
This is a complex intervention
Multiple elements are necessary
Flexibility and tailoring is essential
Each element was valued by some- and not so much by others
Impacts were highlighted in the key domains we expected

Key messages
Trial procedures are feasible and acceptable, and retention, programme
engagement and outcome completion rates were sufficient to satisfy our a
priori trial progression criteria.
The likely primary outcome would be the MSWS-12 vs 2.0
Challenges were experienced in some areas of data collection.
Further development of the BRiMS programme is required to address
logistical issues and enhance user-satisfaction and adherence, which will
benefit from ongoing input from both therapists and people with MS.

However….
There are complications
Simplicity, ease of access and reliability are really
important
Significant personal and MS-related factors impacted on
engagement
Strong preferences amongst some participants
Opinions form VERY quickly!

Thank you for listening
Acknowledgements:
Prof Jenny Freeman
BRiMS project team: Jackie Andrade, Lorna
Paul, Linda Miller, Siobhan Creanor, Kara
Stevens, Colin Green, Paul Ewings, Andy
Barton, MargieBerrow, Jane Vickery, Ben
Marshall,
Prof Marcia Finlayson
Funding: The BRiMS study is funded by the
NIHR Health Technology Assessment
Programme (14/176/12), United Kingdom.

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