Evaluating the Feasibility of Providing a Newly Developed Multifactorial Falls Prevention Programme for Community-dwelling Patients After Stroke.
Phase: NA
Conditions: Stroke
Sponsor: Curtin University

 
                           
 
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Study Protocol 
 
 
Evaluating the feasibility of providing 
a newly developed multifactorial falls prevention programme 
for community-dwelling patients after stroke. 
 
 
 
 
 
Protocol Version and Date: 1.1_2018-03-05 
  
Short Title: The Fall Monty Activity Programme (FallMAP) Feasibility 
Study 
 
REC Reference: HRE2018-0104 
  
Funder: Curtin University 

 
                           
 
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Protocol Summary 
 
Short title: 
The Fall Monty Activity Program Feasibility Study 
Protocol version: 
 
1.1 
Protocol date:  
2018-03-05 
Chief Investigator: 
 
Dr. Lex D. de Jong 
Sponsor: 
Curtin University 
Funder: 
 
Curtin University 
Study design: 
An exploratory mixed-method phase I feasibility study 
with a pre-post design. 
Study aim: 
 
To evaluate the feasibility of providing a newly 
developed multifactorial falls prevention programme 
(‘the Fall Monty Activity Programme’) for community-
dwelling patients after stroke. 
Specific objectives: 
1) to explore the participants’ and the therapists’ 
experiences (barriers, enablers) on the acceptability 
(e.g. 
appropriateness, 
satisfaction, 
safety), 
implementation (e.g. execution, factors affecting 
implementation ease) and practicality (e.g. ability of 
participants and staff to carry out the interventions) of 
the programme. 
2) to explore whether participating in the programme 
can positively influence the participants’ fear of falling, 
quality of life, balance and mobility and social 
engagement. 
Study population/size: 
10 community-dwelling patients after stroke. 
Study duration: 
 
12 months 

 
                           
 
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2. Plain Language Summary 
Between 45-73% of people who have had a stroke fall over in the months and years 
following their stroke. Falls not only lead to physical harm such as hip fractures, but they may 
also lead to an increased fear of falling and a subsequent downwards spiral of inactivity that 
impedes people to perform their everyday activities (such as walking, household and leisure 
activities). This cascade of problems can lead to reduced social participation and reduced 
quality of life. 
 
Research has shown that exercises for strength and balance can help both older people and 
patients after stroke to get fitter, healthier, improve their balance capacity and help them 
prevent having falls. Other key elements in reducing the risk of falls are home safety 
interventions and falls prevention education. Research has further suggested that ‘safe 
landing’ strategies may help to reduce people’s fear of falling and reduce how seriously and 
how frequently people injure themselves from a fall. All this knowledge from previous 
research has prompted falls prevention researchers from Curtin University to developed a 
new, therapist led exercise and multifactorial falls prevention programme called the Fall 
Monty Activity Programme (FallMAP). This programme aims to aid in functional recovery and 
reduce falls by combining a mix of activities such as falls education, strength and balance 
exercises, and activities that teach people how to get up from the floor and how to fall safely. 
The programme also includes a social activity (morning or afternoon tea) after each session. 
Especially because people with residual impairments following a stroke have an increased 
risk of a fall we have decided to test the feasibility of this programme in a small group of 
people after stroke.  
 
The aim of this study is to evaluate the feasibility of providing the FallMAP to community-
dwelling patients (n = 10) after stroke. We want to explore the participants’ and the 
therapists’ experiences (barriers, enablers) on the acceptability (e.g. appropriateness, 
satisfaction, safety), implementation (e.g. execution, factors affecting implementation ease) 
and practicality (e.g. ability of participants and staff to carry out the interventions) of the 
programme, and explore whether participating in the programme can positively influence the 
participants’ fear of falling, quality of life, balance and mobility and social engagement. 
 
Especially because people with residual impairments following a stroke have an increased 
risk of a fall we have decided to test the feasibility of this programme in a small group of 
people after stroke. This study is a first step in establishing whether the different components 
of the FallMAP are acceptable and practical for both patients after stroke and staff who 
deliver the program. In particular, it is important to evaluate if it is feasible to provide the 
seven combined components as one comprehensive programme. Secondly, we want to 
explore whether participating in the programme can positively influence the participants’ fear 
of falling, quality of life, balance and mobility and social engagement. If this feasibility study 
suggests the programme can work in the clinical setting, then a definitive randomised 
controlled trial will be proposed in order to look at whether the full programme is effective at 
reducing falls in patients after stroke. 

 
                           
 
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3. Protocol contacts   
 
Chief Investigator (CI): 
Dr. Lex D. de Jong, Research Fellow 
School of Physiotherapy and Exercise Science 
Faculty of Health Sciences 
Curtin University 
Telephone: +61 8 9266 1861. Email: Lex.deJong@curtin.edu.au  
The CI (Lex D. de Jong) (PhD, MSc PT, BASc PT) is a Research Fellow with over 15 years of clinical experience 
and experience of managing and organising quantitative and qualitative research projects. The PI has ample 
experience in designing trials, preparing ethics applications and trial registration, training assessors and clinical 
staff in administering assessments and interventions, preparing standard operating procedures, case report 
forms, day-to-day trial management, planning and performance of baseline and follow-up actions, financial 
control, data management, data analysis, and preparing manuscripts for publication. In the past two years the CI 
has taken four qualitative courses and has led two mixed-method research studies which included activities such 
as organising and moderating focus groups, performing in-depth interviews, and performing qualitative data 
analysis using thematic analyses. 
 
Co-investigator 1: 
Associate Professor Anne-Marie Hill 
School of Physiotherapy and Exercise Science 
Faculty of Health Sciences 
Curtin University 
Telephone: +61 8 9266 4104. Email: Anne-Marie.Hill@curtin.edu.au  
The CI (Anne-Marie Hill) (PhD, B App Sc; M Sc; Grad Cert.Uni. Cert) is an Associate Professor who previously 
held an NHMRC Early Career Fellowship in the area of falls prevention. She is currently leading falls prevention 
projects in community, residential care and post joint replacement populations. She has worked extensively in 
health department hospitals and has extensive clinical (gerontological physiotherapy) and education experience, 
is a member of the WA Health Department Falls External Advisory Group and is conducting two falls prevention 
trials in WA, sited within WA Health Department settings. She has PhD students working in this area and also 
works with clinical staff in WA to assist in translation of falls prevention evidence into practice. She is experienced 
at leading large randomised trials in WA (currently CIA of a NHMRC funded RCT being conducted in WA) and 
has conducted extended qualitative and quantitative studies. 
 
Co-investigator 2: 
Professor Keith Hill 
School of Physiotherapy and Exercise Science 
Faculty of Health Sciences 
Curtin University 
Telephone: +61 8 9266 3618. Email: Keith.Hill@curtin.edu.au 

 
                           
 
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Co-investigator 3: 
Associate Professor Christopher Etherton-Beer 
Western Australian Centre for Health and Ageing 
The University of Western Australia 
Telephone: +61 8 9224 2750. Email: christopher.etherton-beer@uwa.edu.au 
 
Co-investigator 4: 
 
Dr. Jacqueline Francis-Coad 
School of Physiotherapy 
The University of Notre Dame Australia 
Telephone: +61 8 9433 0187. Email: Jacqui.Francis-Coad@nd.edu.au 
 
Co-investigator 5: 
 
Ms. Elizabeth Bell 
School of Physiotherapy and Exercise Science 
Faculty of Health Sciences 
Curtin University 
Telephone: +61 8 9266 3678. Email: E.Bell@curtin.edu.au 
 
Co-investigator 6: 
 
Ms. Liz Bainbridge 
School of Physiotherapy and Exercise Science 
Faculty of Health Sciences 
Curtin University 
Telephone: +61 8 9266 3623. Email: L.Bainbridge@curtin.edu.au 
 

 
                           
 
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4. Background  
Annually, 15 million people worldwide - and 377,000 Australians - suffer a stroke.(1),(2) A 
stroke can cause muscle weakness, sensory loss, reduced attention, and abnormalities of 
vision and spatial awareness.(3) These impairments in body functions pose a significant 
challenge to maintaining balance and can impact on recovering functional activities (such as 
gait) and preventing falls. Patients after stroke have a very high risk of falling, with incidence 
rates reported to be as high as 45-73% in the chronic phase post-stroke.(4);(5),(6),(7) Due to 
ageing of the population and improvements in post stroke life expectancy the societal impact 
of falls after stroke is growing,(8) for both patients and their carers.(9) Falls not only lead to 
physical harm such as hip fractures,(10) but they may also lead to an increased fear of 
falling(11) and a subsequent downwards spiral of inactivity that can put people closer to or 
below the critical ‘thresholds’ of performance necessary for everyday activities.(12) This 
cascade of problems leads to reduced social participation,(13) and reduced quality of life. 
Exercise as a single intervention is a well established evidence based approach to falls 
prevention in community-dwelling older people(14) and to improving balance capacity in 
patients after stroke.(15) Multifactorial approaches (which typically include group and home-
based exercise programs, home safety interventions and Tai Chi exercises) can also reduce 
the rate of falls(16) in the general older population, but are underexplored(17) in patients 
after stroke. Because all people with residual impairments following a stroke are considered 
at increased risk of a fall(4) and stroke survival has increased,(8) more research in this 
population is urgently needed.(17) 
 
Exercise interventions targeted on strength and dynamic balance which have evidence for 
effective use within falls prevention services are the group based Falls Management 
Exercise (FaME)(18) programme and the Otago home exercise programme.(19) Recent 
systematic reviews and meta-analyses have further provided some preliminary evidence that 
innovative gamified exercises (‘virtual reality’,‘Exergames’) can improve balance and falls risk 
factors after stroke.(20) However, although it has been established that regular participation 
in physical activities and exercise is integral to reduce the risk of falls,(21),(22) other key 
elements are falls prevention education,(23) and providing a home falls hazard 
evaluation.(24),(25) Patients after stroke also value inclusion of a social element.(26),(27) A 
novel approach would be to include safe landing/falling techniques as a component to a 
multifactorial approach as a means to teach individuals how to fall in such a manner to 
reduce injury.(28) Research has suggested that falls involve a predictable series of 
responses which facilitate safe landing,(29) and that fall-related impact forces can be 
reduced by appropriate volitional arrest strategies.(30) To date, research into such safe 
landing/falls technique strategies has only included older subjects on one occasion.(31) 
Adding this latter component to a multifactorial falls prevention intervention may help to 
further reduce the fear of falling and reduce how seriously and how frequently older people or 
people after stroke injure themselves from a fall. Research is warranted to verify the 
effectiveness and suitability of these strategies for at-risk populations.(28) 
 
The Fall Monty Activity Programme (FallMAP) is a novel therapist led exercise and 
multifactorial falls prevention programme recently designed by the falls prevention research 
team at Curtin University specifically for use in patients after stroke to aid in functional 

 
                           
 
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recovery and reduce falls. The programme includes four interventions that are based on best 
available evidence (i.e. falls prevention education, FaME group based exercise programme, 
Otago home exercise programme, and a home falls hazard evaluation) and three 
components that have not previously been investigated as part of multifactorial falls 
prevention approach (i.e. Exergames, safe landing/falls technique training - which includes 
teaching people how to move if on the floor and how to safely get up from the floor-, and a 
social activity undertaken after the exercise sessions). This programme aims to increase falls 
prevention knowledge, increase strength and balance, evaluate home falls hazards, teach 
individuals how to land safely in case of a fall, how to move on the floor and how to get up 
again. The delivery mode of the programme provides participants an opportunity to train and 
socially interact with support from a small group of peers. Feasibility of delivering this 
multifactorial programme requires investigation. 
 
5. Study Aims and Objectives 
Study Aim 
The aim of this research project is to evaluate the feasibility of providing a newly developed 
multifactorial falls prevention programme for community-dwelling patients (n = 10) after 
stroke. 
 
Study Objectives 
1) to explore the participants’ and the therapists’ experiences (barriers, enablers) on the 
acceptability (e.g. appropriateness, satisfaction, safety), implementation (e.g. execution, 
factors affecting implementation ease) and practicality (e.g. ability of participants and staff to 
carry out the interventions) of the programme,  
2) to explore whether participating in the programme can positively influence the participants’ 
fear of falling, quality of life, balance and mobility and social engagement. 
 
6. Method 
Study Design 
This is an exploratory mixed-method phase I feasibility study with a pre-post design. 
 
Participants, Sample Size and Eligibility Criteria 
A convenience sample of 10 patients after stroke will be recruited.  
 
Participants are eligible for participation if they 1) are over 50 and more than 6 months post-
stroke, 2) live in the community, 3) have good cognition (MMSE ≥ 25 points) and 4) are able 
to walk at least three times weekly outside their home without hands on supervision (with or 
without the use of a walking aid). Participants will be excluded if they 1) have medical issues 
preventing them from participating in moderate to vigorous strength and balance exercises 

 
                           
 
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and 2) have receptive aphasia impacting on ability to follow instructions and 3) are unable to 
provide informed consent. 
 
Intervention 
The programme delivered during this feasibility study will consist of a total of 12 multifactorial 
falls prevention group exercise sessions. Each session is 90-100 minutes in duration, 
followed by a 20-30 minute social activity (2 hours in total). The sessions will be offered over 
a period of 8 weeks, with one session in one week and two sessions in the next. Each 
session will comprise (a mix of) seven program components of the intervention: 
1) Falls prevention education: Fifteen minutes of each session will be spent on an existing 
educational programme(23) that is framed on the principles of changes to health behaviour. 
This part of the programme is aimed to alert patients to their personal risk of falls, raise their 
knowledge about falls epidemiology and falls prevention. The educational information will be 
aimed specifically at patients after stroke. 
2) FaME group-based exercises for strength and dynamic balance (these include some basic 
Tai Chi exercises). Fifteen minutes of every other training session will be spent on this part of 
the programme.  
3) (Preparing for) home exercises. Selected components of both the FaME group-based 
exercise programme and the Otago home exercise programme will be practised in order to 
prepare participants to perform these at home for 10-20 minutes per day for the duration of 
the intervention. 
4) Interactive, virtual reality gamefied exercises. This part of the program comprises a Kinect-
based Exergame system (http://mirarehab.com/product) which will be used to transform 
existing physical therapy strength and balance exercises into fun video-games. This element 
is to improve enjoyment, and encourage adherence to the exercise component of the 
programme. In groups of two or three, participants will spend 30 minutes using this system 
between them. Each participant’s training time and training level will be tailored to the 
individual, with the aim to gradually increase training impact. 
5) Getting on and off the floor / floorwork / safe landing & falls technique activities. In groups 
of two or three participants, and over 12 sessions in stepwise progression of duration and 
difficulty, 30 minutes per session will be spent on exploring feelings of being balanced and 
off-balance, feelings of falling, and teaching participants how to fall safely, how to move if on 
the floor, and how to safely get up from the floor. A bespoke training programme (as based 
on similar programmes used in stroke rehabilitation) will be used. To ensure safety, all these 
activities/exercises will be tailored to the individual, supervised and guided on a one-to-one 
basis. 
6) Home falls hazard evaluation. Participants will be issued with the Stay on Your Feet® 
Home Safety Checklist (booklet) and they will be asked to make their home and surrounding 
environment safer according to this checklist. Actions taken and barriers addressed will be 
discussed during (one of the) falls prevention education sessions. 
7) A social activity after the exercise session: Participants will be invited to enjoy a (20-
minute) morning/afternoon tea and socially engage with the other participants/therapists after 

 
                           
 
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each session. Peer to peer support activities of sharing and phone contact will be 
encouraged. 
The intervention will be delivered by two qualified and trained health professionals: a 
physiotherapist and a exercise physiologist. They will deliver the programme to 5 participants 
at the time, so in total two groups will be organised. Although all the activities will be 
delivered during a group session, exercises and activities can (and will) be tailored to (and be 
performed at the discretion of) the individual participants where necessary.  
 
The detailed schedule of the FallMAP sessions is presented in Appendix 1. 
 
Setting 
The FallMAP sessions will be delivered in room 201 of the Curtin Health and Wellness 
Centre, Building 404 on the Bentley Campus. The Health and Wellness Centre has easy 
access in terms of public transport, (limited) patient parking and physical access. 
The main research activities will be performed at the School of Physiotherapy and Exercise 
Science, Faculty of Health Sciences, Building 208, room 3508 (CI). 
 
Quantitative data collection 
Participants who are willing and eligible to participate will be invited to undergo a one-hour 
baseline assessment in the week prior to commencement of the FallMAP programme. During 
this assessment eligibility will need to be confirmed. The first test during this baseline 
assessment will be the Standardised Mini-Mental State Examination (SMMSE; see Appendix 
2). Only if the participant meets the criterion of ≥ 25 points on the SMMSE he/she will be 
allowed to continue with the remainder of the baseline assessment. Participants who score 
below 25 points will be informed that they are not eligible to enrol due to scoring below this 
level on the test. The researcher will advise participants to contact their GP to discuss the 
result. The one-hour outcome assessment will take place within one week of completing the 
programme. 
Participant characteristics 
The following participant characteristics will be collected during the baseline assessment: 
age (years), gender (male/female), time post-stroke (months), side of lesion (left/right), type 
of lesion (ischemic/hemorrhagic), self-rated health status (poor, fair, good, very good, 
excellent), the number of different prescribed medications, if the participant has discussed 
falls with their health provider (yes/no), if the participant is undertaking/has undertaken any 
healthy ageing or falls prevention activities (yes/no), recent falls history (fall in the past 12 
months, yes/no; injured as a result of a fall, yes/no), and if the participant is able to stand up 
from the floor without assistance (yes/no). 
Outcome measures 
The following outcome measures will be administered both at the baseline and outcome 
assessment: 
Questionnaires: 

 
                           
 
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1) a bespoke semi-structured survey about the participants’ falls prevention knowledge (11 
true/false/unsure knowledge statements about falls and falls prevention). 
2) the Short Falls-Efficacy Scale-International (FES-I). The FES-I is a validated and reliable 
7-item tool which measures confidence in performing a range of activities of daily living 
without falling. 
3) The European Quality of Life 5 Dimensions Health Questionnaire (EQ-5D-5L)(32) 
measures health based on a descriptive system that defines health in terms of five 
dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. 
4) the Stroke Impact Scale (SIS) assesses stroke-specific quality of life. The SIS is reliable, 
valid and sensitive to change.(33) 
Balance and Mobility tests: 
5) the Functional Ambulation Classification (FAC) classifies functional ambulation in patients 
undergoing physical therapy.(34),(35) 
6) The Berg Balance Test (36) is a psychometrically sound measure of balance impairment 
for use in poststroke assessment. Given the floor and ceiling effects it is recommended that it 
is used in conjunction with other balance measures. 
7) the 4-Square Step Test (37) is a reliable and valid clinical test of dynamic standing 
balance with high sensitivity and specificity. 
8) the 5-Times Sit-to-Stand Test (38) is a functional mobility test that has excellent reliability 
as a measurement tool that correlates with knee flexors muscle strength.(39) (40) 
All assessments will be conducted by an experienced physiotherapist.  
During the intervention period the participants will be monitored for their adherence to the 
group exercise programme (attendance register kept by the therapists). The participants will 
also be asked to keep a record of the time they spend on their home exercise programme, 
and their fall events (with subsequent injuries) during the intervention period (self-reported 
through diary, see Appendix 3). 
 
Quantitative data collection 
During the outcome assessment participants will be individually interviewed about their 
experiences with the programme by an experienced physiotherapist who was not involved in 
delivering the FallMAP sessions. Family members involved with the patient will also be 
invited to consent (see Appendix 4) an interview. The Patient Information Statement for the 
family members can be found in Appendix 5. 
 
Depending on the group a one-hour focus group may be undertaken. The topics guide for the 
interviews can be found in Appendix 6. 
 
Semi-structured individual interviews of up to an hour’s duration each will be held with the 
two staff members (instructors of the FallMAP sessions) within 2 weeks after all intervention 

 
                           
 
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sessions have been completed. The topics guide for these interviews can be found in 
Appendix 7. 
 
 
Study Data and Data Collection Procedures 
The data collected during this study will consist of six paper questionnaires, physical 
(balance and lower limb strength) tests, audio-recordings (in-depth interviews), field notes 
(observations during the exercise classes), an attendance register and self-report diaries 
(home-exercise compliance and falls events). All assessments will take place in the exercise 
venue. 
 
Baseline assessment  
First the participants will be asked to provide written informed consent. Then the assessor (a 
research physiotherapist) will check the participant’s level of cognition (duration: 10 minutes). 
If sufficient for participation (SMMSE ≥25 points) the participant characteristics will be 
collected (duration 10 minutes) followed by the six questionnaires (duration 20 minutes). 
Finally, the three physical tests will be administered (duration 20 minutes). All questionnaires 
and physical tests can be found in Appendix 2. 
 
Outcome assessment 
After the final (12th) FallMAP session each participant will be invited to undergo a one-hour 
outcome assessment. The research physiotherapist will repeat the five questionnaires 
(duration 20 minutes) and the three physical tests (20 minutes). Finally, the in-depth 
interview will take place (duration: 20-30 minutes). 
 
Staff interviews will take place within two weeks of the final FallMAP session. 
 
Screening, Recruitment and Consent Procedures 
Identification and screening of participants 
Participants will be identified and recruited through promotion of the project to out-patients 
from the researchers’ local network and (if needed) promotion through the Council on the 
Ageing 
(COTA 
WA; 
http://www.cotawa.org.au/) 
and 
Injury 
Matters 
(https://injurymatters.org.au/) newsletters. 
Recruitment procedures 
The main method of recruitment consists of handing out information about the study and an 
example of the informed consent form to identified and potentially eligible participants. The 
Participant Information Statement (Appendix 8) and Consent Form (Appendix 9) for the study 
will be available only in English. Following receipt of the information about the study 
participants can contact the CI if they would like to participate. 
 
People in the networks of the researchers can be active physiotherapists that know patients, 
and who may approach patients who they think are eligible to, and might benefit from, 
participation. To avoid the potential for coercion it will be made explicitly clear to these 
‘recruiting’ active physiotherapists that when they hand out the Patient Information Statement 

 
                           
 
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they must explain to each potential participant that they are not obliged to participate, and if 
they choose not to participate or withdraw after the start of participation, their medical care 
and legal rights will not be affected. 
Consent procedures 
Signed consent (Appendix 9) will be sought prior to the baseline assessment, and only when 
the researcher has ensured that the participant has accessed and understood the 
information provided. Each participant will be asked to sign two informed consent forms; one 
will be retained in the Investigator Site File, and one will be provided to the participant. The 
right to refuse or withdraw (from) participation without giving reasons will be respected. 
 

 
                           
 
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7. Statistical Considerations 
As this is a feasibility study the analyses will be primarily descriptive.  
 
Quantitative data analysis 
The quantitative data collected during this study (participant characteristics, participant 
questionnaires, physical tests, compliance, number of fall incidents, data completion) will be 
analysed and presented descriptively in terms of means (standard deviations), medians 
(interquartile ranges) and categories. Data completeness will also be ascertained of the 
instruments and any potential bias in the completion data to inform the choice of instruments 
in a future trial. 
Qualitative data analysis 
All in-depth interviews will be recorded, fully transcribed verbatim, anonymised and coded. 
Transcripts will not be returned to participants for comments or corrections. The analysis will 
be performed using thematic analysis, which is a method for identifying, analysing and 
reporting patterns (‘themes’) within data.(41) Thematic analysis focuses on similarities and 
differences and results in the organisation of the data from codes into (candidate) themes 
(42). The analysis will be performed by two of the authors (LDdJ, JF-C) with all authors 
agreeing the final themes. Quotes illustrating each theme will be identified for use in the 
publication(s). 
 
Assessment of the feasibility to progress to a full trial 
Following the completion of the qualitative interviews the research team members will have a 
discussion about the practicality of the study design, its impact on and acceptability to, both 
patients after stroke and professionals, and the acceptability and applicability of the outcome 
measures for the intervention. The conclusions from this discussion will inform the 
development of a definitive RCT. The progression criteria to judge the feasibility of 
progressing to a full trial are: 
1. ≥70% of the participants complete 9 of the 12 group sessions (compliance) 
2. <10% of serious adverse events (SAEs) deemed due to the intervention. 
 

 
                           
 
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8. Risks and benefits 
Risks 
During this research study the participants will be exposed to balance challenging exercises, 
and exercises that can result in muscular fatigue. Recent research has shown that older 
people are at increased risk of falling following intensive endurance exercise bouts,(43) 
through exercise induced alterations in respiration and muscular fatigue. The same will be 
true for people who have had a stroke. Increased muscular fatigue may exacerbate existing 
gait and balance difficulties, further increasing the risk of falls. It is therefore essential that 
participants are offered a targeted and appropriately balanced exercise programme which is 
gently increased in duration / exercise load. 
 
Benefits  
In the longer term, participating in this study may have positive impacts on the participants’ 
gait and balance, both physically but also psychologically, in terms of increasing confidence 
and lessening fear of falling which may have resulted in the adoption of falls risk behaviour, 
such as abnormal gait and postural balance and slower walking speeds. This study will add 
to an emerging body of work that is using fear of falling as assessed by a widely validated 
cross cultural tool (the Falls Efficacy Scale-International) to address the gap in knowledge of 
how to manage fear of falling successfully in patients after stroke. Participating in this study 
may further raise awareness amongst the participants of their risk of falling, and may 
motivate them to continue performing healthy ageing activities that are also good for falls 
prevention after the study. A potential third benefit for participants of this study is that it will 
enable them to draw on the existing knowledge about how older adults have low levels of 
self-perceived risk of falls and generally lack the willingness to take up existing falls 
prevention strategies. 
 
Withdrawal of participants 
Participants have the right to withdraw from the study at any time for any reason, and without 
giving a reason. Should a participant decide to withdraw from the study, he/she will be asked 
if they would be happy for the reason for the decision to withdraw to be recorded. The 
investigator also reserves the right to withdraw participants from the study in the event of 
inter-current illness, adverse events (AE), serious adverse events (SAE), or if it is judged that 
it is in the participant’s best interests. 

 
                           
 
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9. Adverse Events Reporting 
For the purpose of this study, an adverse event (AE) is defined as any untoward medical 
occurrence in a participant to whom the study procedure or intervention has been 
administered, including occurrences which are not necessarily caused by or related to that 
intervention. An AE, therefore, does not necessarily have a causal relationship with the 
intervention. Medical conditions/diseases present before starting the intervention are only 
considered adverse events if they worsen after having started participating in the 
intervention. An AE that is not listed in the study protocol as an expected occurrence in the 
circumstances of this study is being considered an unexpected AE. 
 
As described in the risks paragraph above, expected adverse events during participation in 
this study include the following: 
- slips, trips and falls and its consequences: cuts and abrasions, soft tissue injury, fracture. 
- muscular/joint pain associated with the above or with increased physical activity. 
 
All AEs judged by the reporting exercise instructor as having reasonable causal relationship 
to a study procedure or the intervention qualifies as a ‘related AE’. The expression 
“reasonable causal relationship” means to convey in general that there is evidence or 
argument to suggest a causal relationship. An assignment of causality should be made by 
the exercise instructor responsible for conducting the FallMAP sessions using the definitions 
in the table below. All AEs judged as having a reasonable suspected causal relationship to a 
study procedure or the intervention (i.e. definitely, probably or possibly related) are 
considered to be related AEs. If required, the opinion of the participant’s own GP will be 
sought. In the case of discrepant views on causality between the investigator and others, all 
parties will discuss the case. In the event that no agreement is made, Curtin University’s 
HREC will be informed of both points of view. 
 
Relationship 
Description 
Unrelated 
There is no evidence of any causal relationship 
Unlikely 
There is little evidence to suggest there is a causal relationship (e.g. the 
event did not occur within a reasonable time after administration of the 
study procedure).  There is another reasonable explanation for the event 
(e.g. the participant’s clinical condition, other concomitant treatment). 
Possible 
There is some evidence to suggest a causal relationship (e.g. because 
the event occurs within a reasonable time after administration of the 
study procedure).  However, the influence of other factors may have 
contributed to the event (e.g. the participant’s clinical condition, other 
concomitant treatments). 
Probable 
There is evidence to suggest a causal relationship and the influence of 
other factors is unlikely. 
Definitely 
There is clear evidence to suggest a causal relationship and other 
possible contributing factors can be ruled out. 
Not 
assessable 
There is insufficient or incomplete evidence to make a clinical judgement 
of the causal relationship. 
 

 
                           
 
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Any untoward occurrence (whether expected or not) that results in death, is life-threatening 
(refers to an event in which the subject was at risk of death at the time of the event; it does 
not refer to an event which hypothetically might have caused death if it were more severe), 
requires hospitalisation, results in persistent or significant disability or incapacity or is 
otherwise considered medically significant by the participant’s own GP is considered a 
Serious Adverse Event (SAE). SAEs exclude any pre-planned hospitalisations not 
associated with clinical deterioration, routine treatment or monitoring of the studied indication 
not associated with any deterioration in condition, or elective or scheduled treatment for pre-
existing conditions that did not worsen during the study. 
 
AE/SAE Reporting 
Before the start of each FallMAP session, participants will be asked whether they have 
experienced any AEs or SAEs. Any AEs or SAEs reported on the falls diaries will also be 
assessed. All reported AEs and SAEs will be recorded in the patient’s case report form and 
assessed for causality and seriousness. For safety reasons, the CI (LDdJ) and the exercise 
instructors will discuss any recorded related AEs and SAEs reported by the exercise 
instructors during the sessions or as reported by the participants during their 12 weeks of 
participation. All related AEs and SAEs will be reported to all investigators and Curtin’s 
Human Research Ethics Committee (HREC) by the CI within five working days of their 
occurence. The research team will monitor any trends in related AEs and SAEs and bring the 
programme to a close, should this be deemed necessary. 
 
To reduce the possibility of AEs and SAEs during the project the exercise deliverers 
(physiotherapist) will be qualified to deliver exercise programs to older people and ensure the 
exercises undertaken by the exercise participants are safe and clearly understood. 
 
 
10. Risk Management 
Any incident (including falls) of a participant during their visit to the Health and Wellness 
Centre (including the FallMAP exercise sessions) will be handled in accordance with the 
general emergency procedures of the venue (see Appendix 10). This procedure is in line with 
Curtin 
University’s 
Incident 
and 
Hazard 
Reporting 
procedure: 
(https://healthandsafety.curtin.edu.au/event_and_hazard/index.cfm). 
 
 

 
                           
 
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11. Data Handling & Record Keeping 
The information collected during this research study will be mainly re-identifiable (coded). 
The audio-recordings of the interviews will be transcribed and the transcripts will 
subsequently be anonymised. As such the qualitative data is non-identifiable (anonymous).  
 
Any information collected will be treated as confidential and used only in this study unless 
otherwise specified. All source data relating to consented study participants will be stored 
and processed in line with Curtin University requirements. All source data held in paper form 
(Case Report Forms) will be scanned and securely stored in a locked filing cabinet in the 
research office at Curtin University as soon as possible after data collection. 
 
Scans of the paper versions of data will be saved on Curtin University’s R-drive. These data 
will also be entered into a computer spreadsheet, and backed up, on Curtin University’s R-
drive. Only the CI and will have access to this secure area. All source data held in audio-form 
(in-depth interviews with participants and staff) will be uploaded to Curtin University’s R-drive 
as soon as the PI is back at their work base. Copies held on the audio recorders will be 
deleted as soon as they are uploaded successfully. All copies of audio recordings will be 
destroyed once they are successfully transcribed, anonymised and backed up. All qualitative 
data will be stored on Curtin University’s R-drive to which only the PI and CI will have 
access. 
 
All data and consent forms collected during this study will be kept under secure conditions at 
Curtin University for 25 years after the research has ended and then it will be destroyed. 
 
12. Ethics & Regulatory Issues 
The conduct of this study will be in accordance with the recommendations as described in 
the National Statement on Ethical Conduct in Research (2007, updated May 2015). 
Favourable ethical opinion from the Human Research Ethics Office (HREC) of Curtin 
University approval will be sought prior to commencement of the study. Information sheets 
will be provided to all eligible subjects and written informed consent obtained prior to any 
study procedures.  
Confidentiality 
Personal data will be regarded as strictly confidential. To preserve anonymity, any data 
leaving the site will identify participants by their initials and a unique study identification code 
only. All study records will be kept at Curtin University in a locked filing cabinet with restricted 
access. 
Study Report / Publications 
The data will be the property of the CI. Publication will be the responsibility of the CI. It is 
planned to publish this study in peer review articles and to present data at national and 
international meetings. Individuals will not be identified from any publication. Participants will 
be informed about the study, including a lay summary of the results. 

 
                           
 
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