A Backwards Walking Programme Following Hip and Knee Arthroplasty: A Feasibility Pilot Study
Phase: NA
Conditions: Hip Osteoarthritis, Knee Osteoarthritis, Hip Arthroplasty, Knee Arthroplasty
Sponsor: Oxford University Hospitals NHS Trust

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Study Title:  A Backwards Walking Programme following Hip and Knee Arthroplasty: A Feasibility Pilot 
Study 
Ethics Ref: 20/SC/0078 
IRAS Project ID:  
Date and Version No: 18/03/2020 v1.2 
 
Chief Investigator: 
Mrs Martha Batting 
Physiotherapy Research Unit 
Nuffield Orthopaedic Centre 
Windmill Road 
Headington 
OX3 7HE 
Phone: 01865 737526 
Email: Martha.batting@ouh.nhs.uk 
Investigators:  
Professor Karen Barker 
Physiotherapy Research Unit and Nuffield Department of Orthopaedics, 
Rheumatology and Musculoskeletal Sciences 
 
Sponsor:  
Oxford University Hospitals NHS Foundation Trust  
Funder: 
Physiotherapy Research Unit, Nuffield Orthopaedic Centre 
Chief Investigator Signature:   
 
 
Confidentiality Statement 
This document contains confidential information that must not be disclosed to anyone other than the 
Sponsor, the Investigator Team, HRA, host organisation, and members of the Research Ethics Committee, 
unless authorised to do so

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TABLE OF CONTENTS 
 
1. 
KEY CONTACTS ........................................................................................................................ 4 
2. 
LAY SUMMARY ........................................................................................................................ 4 
3. 
SYNOPSIS ................................................................................................................................ 5 
4. 
ABBREVIATIONS....................................................................................................................... 6 
5. 
BACKGROUND AND RATIONALE................................................................................................ 6 
6. 
OBJECTIVES AND OUTCOME MEASURES.................................................................................... 8 
7. 
STUDY DESIGN ......................................................................................................................... 9 
8. 
PARTICIPANT IDENTIFICATION .................................................................................................. 9 
8.1. 
Study Participants............................................................................................................. 9 
8.2. 
Inclusion Criteria .............................................................................................................. 9 
8.3. 
Exclusion Criteria .............................................................................................................. 9 
9. 
PROTOCOL PROCEDURES ........................................................................................................10 
9.1. 
Recruitment ....................................................................................................................10 
9.2. 
Screening and Eligibility Assessment .................................................................................11 
9.3. 
Informed Consent............................................................................................................11 
9.4. 
Randomisation ................................................................................................................11 
9.5. 
Blinding and code-breaking ..............................................................................................12 
9.6. 
Description of study intervention(s), comparators and study procedures (clinical)...............12 
9.6.1. 
Description of study intervention(s) ..............................................................................12 
9.6.2. 
Description of comparator(s) ........................................................................................13 
9.7. 
Baseline Assessments ......................................................................................................13 
9.8. 
Subsequent Visits ............................................................................................................15 
9.9. 
Sample Handling..............................................................................................................15 
9.10. 
Early Discontinuation/Withdrawal of Participants..............................................................16 
9.11. 
Definition of End of Study ................................................................................................16 
10. 
SAFETY REPORTING.................................................................................................................16 
10.1. 
Definition of Serious Adverse Events.................................................................................17 
10.2. 
Reporting Procedures for Serious Adverse Events..............................................................17 
11. 
STATISTICS AND ANALYSIS .......................................................................................................17 
11.1. 
Statistical Analysis Plan (SAP) ...........................................................................................17 
11.2. 
Description of the Statistical Methods ..............................................................................17 

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11.3. 
Sample Size Determination ..............................................................................................18 
12. 
DATA MANAGEMENT ..............................................................................................................18 
12.1. 
Source Data.....................................................................................................................18 
12.2. 
Access to Data .................................................................................................................19 
12.3. 
Data Recording and Record Keeping .................................................................................19 
13. 
QUALITY ASSURANCE PROCEDURES .........................................................................................19 
13.1. 
Risk assessment...............................................................................................................20 
13.2. 
Study monitoring .............................................................................................................20 
13.3. 
Study Committees ...........................................................................................................20 
14. 
PROTOCOL DEVIATIONS ..........................................................................................................20 
15. 
SERIOUS BREACHES.................................................................................................................20 
16. 
ETHICAL AND REGULATORY CONSIDERATIONS .........................................................................20 
16.1. 
Declaration of Helsinki .....................................................................................................21 
16.2. 
Guidelines for Good Clinical Practice.................................................................................21 
16.3. 
Approvals........................................................................................................................21 
16.4. 
Other Ethical Considerations ............................................................................................21 
16.5. 
Reporting ........................................................................................................................21 
16.6. 
Participant Confidentiality................................................................................................21 
16.7. 
Expenses and Benefits .....................................................................................................22 
17. 
FINANCE AND INSURANCE.......................................................................................................22 
17.1. 
Funding...........................................................................................................................22 
17.2. 
Insurance ........................................................................................................................22 
17.3. 
Contractual arrangements................................................................................................22 
18. 
PUBLICATION POLICY ..............................................................................................................22 
19. 
DEVELOPMENT OF A NEW PRODUCT/ PROCESS OR THE GENERATION OF INTELLECTUAL 
PROPERTY .........................................................................................................................................23 
20. 
ARCHIVING .............................................................................................................................23 
21. 
REFERENCES ...........................................................................................................................24 
22. 
Appendix 1 .............................................................................................................................26 
 
 
 

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1. KEY CONTACTS 
 
Chief Investigator 
Martha Batting 
Physiotherapy Research Unit, 
Nuffield Orthopaedic Centre 
Windmill Road, 
Headington, 
Oxford, 
OX37HE 
01865 737526 
Email: Martha.batting@ouh.nhs.uk 
 
Sponsor 
Oxford University Hospitals NHS Foundation Trust 
Funder(s) 
Physiotherapy Research Unit, Nuffield Orthopaedic Centre 
Statistician 
N/A 
2. LAY SUMMARY  
 
Backwards walking has been shown to improve balance and walking in patients who have knee 
Osteoarthritis. We don’t know if these benefits may also be seen after surgery with patients who have 
had a hip or knee replacement because of Osteoarthritis. This study will look to see if it is possible to 
conduct a bigger study into how effective backwards walking may be after joint replacement. Patients 
who come to the Nuffield Orthopaedic Centre in Oxford for a hip or knee replacement will be invited.  
They will be placed into one of two groups at random: a group where they have a course of 
physiotherapy plus a backwards walking programme or a group where they have a course of 
physiotherapy. The physiotherapy will last for 12 weeks and those who take part will take part in two 
study assessments. The first will be before any treatment and patients will complete five measures and 
also be issued with a simple tick box diary to complete over the 12 weeks. The second assessment will be 
after the treatment and will involve the same 5 measures and the diaries will be collected in. Participants 
at this assessment will also be asked if they would like to take part in an interview for the study. This is to 
see what the patients thought of the study. During the study the researcher will record things like how 
many patients say ‘yes’ to the study and how many participants drop out of the treatment to understand 
if a bigger study could take place.  
 
 
 
 

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3. SYNOPSIS 
Study Title 
A Backwards Walking Programme following Hip and Knee Arthroplasty: A 
Feasibility Pilot Study 
Internal ref. no. / short 
title 
Backwards Walking in patients following Knee and Hip Replacement 
Study registration 
 
Sponsor  
Oxford University Hospitals NHS Foundation Trust 
Funder  
N/A   
Study Design 
Mixed methods feasibility pilot study  
Study Participants 
Men and women who have undergone hip or knee arthroplasty  
Sample Size 
40 participants/ 20 per group 
Planned Study Period 
12 months total length/ individual participant involvement 3 months  
 
Planned Recruitment 
period 
01/03/2020 to 01/09/2020 
 
Objectives 
Outcome Measures 
Time point(s) 
Primary 
 
To test the 
procedures and 
processes of the 
trial and to 
estimate 
parameters for the 
main trial sample 
size calculation 
• 
Berg Balance Scale 
• 
Participant 
recruitment 
figures 
• 
Participant 
retention 
figures 
• 
Number 
of 
protocol 
violations  
• 
BW programme diary 
• 
Qualitative interviews 
Baseline and 3 
months 
Secondary 
 
To examine the 
consistency of the 
effects of the 
backwards walking 
programme on falls 
risk, balance, 
strength and gait 
speed following hip 
and knee joint 
arthroplasty  
• 
Four Square Step Test 
• 
2 minute walk test 
• 
30 second stand test 
• 
Activities-specific Balance 
confidence scale 
• 
Falls diary 
Baseline and 3 
months 
Intervention(s) 
A 12 week backward walking programme alongside a standard course of 
physiotherapy 
Comparator 
Standard course of physiotherapy   
 
 
 

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4. ABBREVIATIONS 
 
CI 
Chief Investigator 
CRF 
Case Report Form 
CTRG 
Clinical Trials & Research Governance, University of Oxford 
GCP 
Good Clinical Practice 
GP 
General Practitioner 
HRA 
Health Research Authority 
ICF 
Informed Consent Form 
NHS 
National Health Service 
RES 
Research Ethics Service 
OXTREC 
Oxford Tropical Research Ethics Committee 
PI 
Principal Investigator 
PIL 
Participant/ Patient Information Leaflet 
R&D 
NHS Trust R&D Department 
REC 
Research Ethics Committee 
SOP 
Standard Operating Procedure 
 
5. BACKGROUND AND RATIONALE 
In recent years the number of elective hip and knee joint arthroplasties has been steadily increasing with 
the National Joint Registry reporting 97,792 primary hip replacements and 102,944 primary knee 
replacements were carried out in the year 2018 alone1. Older patients who have undergone a Total Hip 
Arthroplasty (THA) or Total Knee Arthroplasty (TKA) or Uni-compartmental Knee Arthroplasty (UKA) are 
known to be at an increased risk of falls. Studies have reported an incidence rate of falls of up to 40%2 
following TKA and 36% post THA3 whereas the prevalence of falls for community dwelling older adults is 
28%4.  This increase in risk of falls for patients following joint arthroplasty is thought to be present due to 
the reduction in joint proprioception and a short term increase in pain alongside a reduction in muscle 
strength2,5. These factors in combination with hospital admission itself predispose those older adults who 
are likely to have less physical reserves than their younger counterparts to falls 6.  
Falls have a multifactorial aetiology and there are several physiotherapy interventions developed to help 
target these contributing factors including gait re-education and strength and balance training7. 
However, the majority of conventional physiotherapy programmes currently fail to include a backwards 

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walking (BW) element to improve balance and decrease the risk of falls. The ability to take multi 
directional protective steps when exposed to forward, backward and lateral perturbations can decrease 
your risk of falls. However to effectively sustain balance, steps must be appropriately directed, timed, 
and executed to arrest the motion of the body’s centre of mass by altering the base of support 8. Without 
practice of BW patients following joint arthroplasty with their known reduction in strength and 
proprioception are less likely to be able to take a protective backwards step to prevent falls.  
BW is a form of closed kinetic chain exercise which is known to be more functional, safe and effective 
than open kinetic chain exercises due to the reduced compressive forces at the patellofemoral joint 9. 
Compared to forward walking, lower limb muscle activity during backward walking is greater due to the 
higher recruitment of motor units10. In addition, BW has been seen to increase cardio-pulmonary 
demand11 helping to improve the cardiovascular fitness of patients. The absence of visual cues also 
increases the spatial and temporal gait parameters12. BW does not require any specific equipment thus is 
a cost effective and easy mode of rehabilitation. Additionally once it has been completed under 
supervision a BW programme can be continued as part of a home exercise programme. Taking into 
consideration all of these factors BW could form an important functional and strengthening role in the 
rehabilitation of patients post THA and TKA/UKA.  
There have been a number of studies looking at BW for different musculoskeletal conditions. A recent 
literature review and meta-analysis concluded that although there was sufficient evidence to 
recommend a BW programme as part of a rehabilitation programme for patients with knee 
osteoarthritis, other conditions still required further evidence 13. Patients following hip and knee 
arthroplasty differ from the populations with knee OA as they have greater strength deficits 14 and lower 
activity levels post operatively15 making them more at risk of falls.  To date there are no randomised 
controlled trials (RCT) looking at a BW programme for this population. It is therefore pertinent that we 
look at the effectiveness of BW post hip and knee arthroplasty in reducing the risk of falls and improving 
balance and physical function in a RCT. This feasibility pilot will be the first step to delivering the RCT and 
will test the procedures and acceptability of a BW programme for patients following THR/TKA/UKA.  
 
 
 
 

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6. OBJECTIVES AND OUTCOME MEASURES 
 
Objectives 
Outcome Measures  
Timepoint(s) 
of 
evaluation of this 
outcome measure 
(if applicable) 
Primary Objective 
To test the procedures and 
processes of the trial and to 
estimate parameters for the main 
trial sample size calculation  
• 
Berg Balance Scale (BBS) (to calculate 
sample size) – Static and dynamic 
balance activities of varying difficulty 
are performed to provide a measure of 
falls risk and balance  
• 
Participant recruitment figures 
• 
Participant retention figures 
• 
Randomisation acceptability 
• 
Number of protocol violations from 
fidelity checks 
• 
BW programme diary to provide a 
measure of adherence  
• 
Participant safety through recording 
any falls and injuries whilst completing 
the BW programme 
• 
Qualitative interviews to determine 
acceptability 
of 
intervention 
and 
delivery 
with 
participants 
and 
physiotherapists 
Baseline 
and 
3 
months 
Secondary Objectives 
To examine the consistency of the 
effects of the backwards walking 
programme on falls risk, balance, 
strength and gait speed following 
hip and knee joint arthroplasty 
• 
Four Square Step Test (FSST)- a test of 
dynamic balance that clinically 
assesses a person’s ability to step over 
objects forward, sideways, and 
backwards 
• 
2 minute walk test (2MWT)- assesses 
walking distance  
• 
30 second chair rise test - assesses sit 
to stand ability and provides a 
measure of lower limb strength and 
dynamic balance. 
• 
Activities-specific Balance confidence 
scale (ABC) - self-reported measure 
of confidence in performing 
various ambulatory activities without 
falling 
• 
Falls diary - records the frequency of 
falls 
Baseline 
and 
3 
months 

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7. STUDY DESIGN 
This study is a mixed methods design. The quantitative study will be a randomised single blinded design.  
Up to 40 participants will be recruited from a single site at the Nuffield Orthopaedic Centre in Oxford. 
After recruitment baseline outcome measures will be taken. Block randomisation will then be used to 
balance stratification factors (hip or knee arthroplasty) into either the intervention or control group. The 
participant will receive their physiotherapy intervention or control at the Nuffield Orthopaedic Centre 
which will last up to 12 weeks. Once the first 5 participants randomised into the intervention arm have 
been recruited the study will be halted whilst all adverse event data is collected to ensure participants 
have not fallen when completing the intervention. If the study team is happy the intervention is not 
causing any adverse events, then the next five participants will be recruited and again the study will halt 
whilst their adverse event data is collected. This will continue until all 20 participants for the intervention 
group are recruited. Outcome measures will be repeated at 12 weeks once the treatment has ceased. 
This will be the final data collection point for the study.  
 
The qualitative element of the study will involve semi structured interviews. This will take place after the 
participants have completed their 12 week follow up and physiotherapists have completed the 
intervention delivery. We will interview to a point of theoretical saturation16, and anticipate that up to 10 
participants and 5 physiotherapists will allow us to develop useful themes.  
8. PARTICIPANT IDENTIFICATION 
 
8.1. Study Participants 
 
Patients who have undergone either hip or knee arthroplasty will be eligible for inclusion if they meet 
the following criteria: 
8.2. Inclusion Criteria 
 
• 
Men and women aged 65 or older 
• 
Participant is willing and able to give informed consent for participation in the study. 
• 
Participants who have received a primary unilateral hip or knee arthroplasty due to osteoarthritis  
8.3. Exclusion Criteria 
 

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• 
Post-operative weight bearing restrictions  
• 
Post-operative complications such as infection, a deep vein thrombosis or pulmonary embolism, 
or failure of the wound to heal.   
• 
Inability to undertake a backwards walking programme due to conditions such as severe 
cardiovascular or pulmonary disease (New York Heart Association III-IV). 
• 
Severe dementia or communication difficulties that would prevent completion of study 
assessments. 
• 
Any neurological condition. 
• 
Further planned treatment on the same or contralateral hip or knee within next 6 months 
• 
Registered as visually impaired  
9. PROTOCOL PROCEDURES  
9.1. Recruitment 
 
Patients who have had a hip or knee replacement at the Nuffield Orthopaedic Centre in Oxford attend a 
6 week post discharge clinic appointment. These patients will be screened for eligibility by their direct 
care team (Nuffield Orthopaedic Centre Physiotherapists). They will be introduced to the study by either 
a letter in the post from their direct care team (which will be sent alongside their clinic appointment 
letter) with information about the study and invitation letter and reply slip, or they will be introduced to 
the study and given the study information by their direct care team during their routine clinical 
appointment. Patients will be given ample time to consider taking part in the study. If they express an 
interest in the study the investigator will review the study details and answer any questions they may 
have. They will then be screened for eligibility and those who meet the criteria will take part in the study. 
If they agree to take part an appointment will be made to obtain consent and record baseline data and 
outcome measures with a trial research clinician at the Nuffield Orthopaedic Centre. Once patients have 
completed their baseline assessment they will be randomised according to the procedure set out below.  
Those who do not wish to take part will be asked if they can provide a reason for declining so that 
recruitment onto the trial can be analysed. The trial research clinician will also record the number of 
responders to the study information. As detailed in the study design section after the first 5 participants 
have been recruited to the intervention arm the study will stop whilst adverse event data is collected to 
ensure participants are not falling during the intervention. Providing this is not the case the study will 
resume and continue to stop and evaluate adverse event data for every 5 participants in the intervention 
arm.  

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9.2. Screening and Eligibility Assessment 
 
The maximum time between screening and randomisation will be 2 months. During the screening 
process no exceptions will be made regarding eligibility and each participant must satisfy all the 
approved inclusion and exclusion criteria stated in section 8.  
The healthcare professional that carried out the clinic appointment will screen the participant using the 
criteria provided. This will involve reviewing the patients’ medical notes. 
 
9.3. Informed Consent 
 
Informed consent will be taken by an experienced physiotherapy researcher who has completed specific 
training in taking consent including Good Clinical Practice Training and has experience taking consent for 
participating in physiotherapy research.  
The participant must personally sign and date the latest approved version of the Informed Consent form 
before any study specific procedures are performed. 
Written and verbal versions of the Participant Information and Informed Consent will be presented to 
the participants detailing no less than: the exact nature of the study; what it will involve for the 
participant; the implications and constraints of the protocol; the known side effects and any risks 
involved in taking part. It will be clearly stated that the participant is free to withdraw from the study at 
any time for any reason without prejudice to future care, without affecting their legal rights, and with no 
obligation to give the reason for withdrawal. 
The participant will be allowed as much time as wished to consider the information, and the opportunity 
to question the Investigator, their GP or other independent parties to decide whether they will 
participate in the study. Written Informed Consent will then be obtained by means of participant dated 
signature and dated signature of the person who presented and obtained the Informed Consent. A copy 
of the signed Informed Consent will be given to the participant. The original signed form will be retained 
at the study site. 
9.4. Randomisation 
 
Participants will be randomised once informed consent has been gained. A randomisation list will be 
generated using the web-based randomisation system Sealed Envelope17 by an independent researcher 

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at the study site who is not part of the study team. Randomisation will be stratified by arthroplasty type. 
Permuted block randomisation will be used to ensure the strata are balanced between the groups. The 
independent researcher will then follow the sequence list generated to write each individual allocation in 
an opaque sealed envelope which will be labelled on the outside in number order from 1-20 with each 
stratum beside it (knee or hip arthroplasty). When a participant has completed the baseline study 
assessment a second independent researcher will take the opaque sealed envelope in number sequence, 
based on the participant’s type of arthroplasty, to determine that participant’s treatment allocation. This 
treatment allocation will then be passed onto the treating physiotherapist via a referral form and the 
participant will be informed of their group allocation when they attend their physiotherapy sessions. The 
second independent researcher will also complete a randomisation log to document each participant’s 
allocation.   
9.5. Blinding and code-breaking 
 
The trial research clinician who is completing the study assessments will remain blinded to the 
participant allocation and will not be involved in any part of the randomisation procedure to ensure that 
they are not able to bias the group allocation. Due to the nature of the intervention it is not possible to 
blind the participant or treating clinician.  
As participants and treating clinicians are not blinded to the treatment allocation it is not necessary to 
have a code-breaking procedure.  
9.6. Description of study intervention(s), comparators and study procedures (clinical) 
9.6.1. Description of study intervention(s)  
 This group will undertake a routine course of one to one out-patient physiotherapy which will include a 
BW programme. The BW programme will be prescribed by a physiotherapist and the participant will 
carry it out, along with other prescribed exercises, in their own home. Aside from the BW programme 
the physiotherapy treatments offered in the initial and review sessions will not be restricted but will be 
recorded in treatment logs. Each participant will initially be prescribed a 5 minute BW programme to be 
completed once a day. Participants will score the intensity of their backwards walking based on the 
BORG rating of perceived exertion scale. The aim will be for participants to be working at the light to 
somewhat hard level on the scale (11-14) (see appendix 1). The length of the BW programme and 
intensity will be progressed or regressed as deemed appropriate by the treating clinician with the aim for 
patients to achieve at least 10 minutes of BW every day of the week by the end of the programme.  The 

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programme will be issued for completion over the course of 12 weeks and up to four review 
appointments will be made with the participant to monitor the BW programme and other prescribed 
exercises. To promote adherence a BW programme diary will be issued to participants to complete each 
time they carry out the programme in their own homes.  
The intervention was developed in line with the MRC developing complex intervention guidelines 18. The 
guidelines state a three stage process should be used to develop interventions including identifying 
existing evidence, identifying and developing theory and modelling process and outcomes. The initial 
stage of identifying evidence was conducted by reviewing a recent literature review which appraised 11 
studies with a backwards walking programme for musculoskeletal conditions13. The studies ran over no 
more than 4 weeks and each session lasted between 5 to 10 minutes. From this we surmised that as 
these patients would have recently had joint replacement surgery they may struggle with the intensity of 
a 10 minute programme used in other musculoskeletal conditions. It was determined therefore that 
initially the sessions should start at 5 minutes and that the treating therapists should clinically reason 
when to progress each participant up to the maximum 10 minute BW programme. All the studies were 
conducted in a supervised environment with some participants returning daily to complete the BW 
programme under supervision. This was not deemed feasible in an NHS setting where clinical resources 
are limited and so along with consultation from clinical specialists it was determined that the programme 
should initially be prescribed by a physiotherapist and once the patient could complete this safely this 
should be issued for completion at home over 12 weeks. This formed the identifying and developing 
theory process. The final stage is modelling and outcomes which will be tested in this feasibility pilot 
study.  
9.6.2. Description of comparator(s)  
 
This group will undertake a routine course of one to one out-patient physiotherapy over 12 weeks. To 
allow comparison between the two groups the control group will also have up to four review 
appointments where their home exercise programme can be progressed or regressed. The 
physiotherapy treatments will not be restricted (apart from no BW programme) to allow for a pragmatic 
approach based on the treating clinician’s clinical judgement, however their content will be recorded on 
treatment logs.   
9.7. Baseline Assessments 
 

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After written informed consent is taken, the baseline assessment measurements will commence. The 
research clinician will take general demographic information, relevant medical history, falls history, type 
of arthroplasty and height and weight. They will then carry out the following physical measures: 
BBS – The BBS is a validated measure of balance for patients with osteoarthritis with normative data for 
post hip and knee replacement available19.  The participant is asked to complete fourteen different 
balance test including sit to stand, stand to sit, unsupported standing, unsupported sitting, transfers, 
standing with eyes closed, standing with feet together, reaching forward, picking up an object from the 
floor, turning to look behind, 360 degree turn, step onto stool, tandem stance and single leg stance. Each 
task is marked out from 0 to 4 with 4 being the best score. The test is totalled out of 56 with higher 
scores indicating lower falls risk. 
FSST -  This clinical test is a valid and reliable measure of dynamic balance in older adults20.  The 
participant is timed during multi-directional stepping into four different quadrants separated by walking 
sticks. The participant will step forward over a stick, step to the right sideways over a stick, step 
backwards over a stick and step to the left sideways over a stick; the sequence will immediately be 
repeated in reverse. The participant will start over if he/she touches a stick with his/her foot or if it is 
completed in the wrong sequence. The total time taken to complete this test will be recorded. 
2MWT – Provides a measure of gait speed and distance21. The participant will walk 20-metre laps for two 
minutes. The distance completed during the two minutes will be recorded to provide a measure of 
endurance. Assistive devices can be used but must be consistent between testing.  
30s Chair rise test – This is a validated clinical measure of lower body strength and dynamic balance 
which is recommended as one of the best physical performance tests following joint arthroplasty by 
OARSI22. The participant is asked to sit in a straight back chair of 17” seat height without arms. From the 
sitting position, the participant stands up completely up so hips and knees are fully extended, then 
completely back down, so that the bottom fully touches the seat. This is repeated for 30 seconds and the 
participant should not use their hands to get up. If the participant is unable to do this they are allowed to 
place their hands on their knees or use their regular mobility aid to rise from the chair and this is 
recorded as an adapted score.  
Following the collection of the physical outcome measures the participants will be asked to complete the 
ABC questionnaire. This provides a measure of balance confidence whilst performing certain tasks and is 
a 16 item self-report measure. Each question is scored out of 100 with 0 representing no confidence and 
100 representing total confidence. The average of all scores is used to provide a final score and 
normative data is available for older adults23.  

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At the end of the assessment the participant will be issued with a falls diary to complete for the 3 
months whilst they are taking part in the study. For those randomised to the intervention arm a diary of 
adherence to the BW programme will also be issued at the initial physiotherapy appointment.  
9.8. Subsequent Visits 
 
As this is a feasibility pilot study the main aims are not to assess the effectiveness of the intervention but 
to trial the acceptability and feasibility of the study protocol and pilot its delivery at the Nuffield 
Orthopaedic Centre in Oxford. For this reason the main assessments for the study relate to recruitment, 
retention and acceptability. The research clinician will therefore collect data throughout the trial on the 
number of patients screened, the number that consented, the reason for not consenting, the number of 
drop outs, the availability of the outcome measure data and the standard deviation of the BBS in order 
to estimate the sample size. The acceptability of the intervention will be measured through collection of 
the BW programme diary which will provide a measure of adherence. Participants will also be invited to 
take part in an interview to determine the study acceptability.  
Fidelity checks 
Fidelity checks will be made by a member of the study team who is not blinded to treatment allocation 
to ensure adherence to the study protocol from the recruiting and treating clinicians. These will take 
place mid-way through study recruitment once approximately 20 participants have been randomised.  
12 week follow up 
Participants will be followed up at 12 weeks for the final assessment. Participants will be asked to return 
to the physiotherapy clinic or where possible this appointment will tie in with their final physiotherapy 
appointment at 12 weeks. The outcome measure assessments will be the same as at baseline and the 
research clinician will ensure they collect in the falls diary and if applicable BW programme diary.  
Qualitative interviews 
Patients taking part in the study, and treating clinicians, will be invited to take part at the in a semi-
structured interview to determine if the study procedures and trial design were acceptable to 
participants. This will take place after the participants have completed their 12 week follow up and 
physiotherapists have completed the intervention delivery.  
9.9. Sample Handling  

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No samples will be taken.  
9.10. 
Early Discontinuation/Withdrawal of Participants 
 
Each participant has the right to withdraw from the study at any time.  In addition, the Chief Investigator 
(CI) may discontinue a participant from the study interventions at any time if the investigator considers it 
necessary for any reason including:  
• 
Ineligibility (either arising during the study or retrospectively having been overlooked at 
screening) 
• 
A significant protocol deviation  
• 
A significant non-compliance with treatment regimen or study requirements  
• 
An adverse event which requires discontinuation of the study intervention or results in inability 
to continue to comply with trial procedures  
It will be the sole responsibility of the CI to determine whether investigator-led discontinuation occurs or 
not.   
The treating clinician may withdraw a participant from the study if they feel it would not be clinically 
appropriate for them to continue.  
If the participant has withdrawn from study treatment then they will be encouraged to continue with the 
follow-up.  
Participants who wish to withdraw consent for the study or whose participation from the trial is 
discontinued will have de-identifiable data collected up to the point of that withdrawal of consent, 
included in the analyses, unless the participant specifically asks for all data collected to be destroyed. The 
participant will not contribute further data to the trial and the withdrawal CRF will be completed which 
documents the level of withdrawal. The reason for withdrawal will also be recorded. Participants who 
withdraw once they have been randomised will not be replaced. 
9.11. 
Definition of End of Study 
 
The end of study is the point at which all the study data has been entered and queries resolved. 
10. SAFETY REPORTING  

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The safety reporting window will start from the time of consent to the point that the participant 
completes the study. The investigator will follow up SAEs until event resolution or stabilisation for 
related events only. 
10.1. 
Definition of Serious Adverse Events 
A serious adverse event is any untoward medical occurrence that: 
• 
results in death 
• 
is life-threatening 
• 
requires inpatient hospitalisation or prolongation of existing hospitalisation 
• 
results in persistent or significant disability/incapacity 
• 
Consists of a congenital anomaly or birth defect. 
Other ‘important medical events’ may also be considered a serious adverse event when, based upon 
appropriate medical judgement, the event may jeopardise the participant and may require medical or 
surgical intervention to prevent one of the outcomes listed above. 
NOTE: The term "life-threatening" in the definition of "serious" refers to an event in which the 
participant 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. 
10.2. 
Reporting Procedures for Serious Adverse Events 
A serious adverse event (SAE) occurring to a participant should be reported to the REC that gave a 
favourable opinion of the study where in the opinion of the Chief Investigator the event was ‘related’ 
(resulted from administration of any of the research procedures) and ‘unexpected’ in relation to those 
procedures. Reports of related and unexpected SAEs should be submitted within 15 working days of the 
Chief Investigator becoming aware of the event, using the HRA report of serious adverse event form (see 
HRA website). 
11. STATISTICS AND ANALYSIS 
11.1. 
Statistical Analysis Plan (SAP) 
 
The plan for the statistical analysis of the study is outlined below. There is not a separate SAP document 
in use for the trial. 
11.2. 
Description of the Statistical Methods  
 

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This is a feasibility pilot RCT, therefore the aim of this study is not to provide a measure of efficacy but to 
determine whether it is possible to run a large scale RCT. Participant demographics will be summarised 
using standard descriptive statistics. The following components will also be analysed: 
• 
The mean and SD of the primary outcome measure the BBS will be analysed to provide a sample 
size calculation for a larger RCT 
• 
Recruitment – The number of recruited participants in the recruitment window, the number of 
participants screened to allow for the recruitment target to be met and the reason for non-entry 
into the trial which will provide realistic expectations of recruitment for a future larger scale 
RCT.  
• 
Randomisation – Is randomisation acceptable to participants in this study? Does randomisation 
create comparable groups?  
• 
Intervention acceptability – Is the intervention acceptable to participants? Do any participants 
fail to complete the intervention? Adherence to the prescribed BW programme will be measure 
through a collection of a diary. These issues will also be explored in more depth as part of the 
qualitative study. 
• 
Retention of participants – Drop outs and wherever possible the reason for drop out will be 
recorded. 
• 
Fidelity - Fidelity checks will be conducted, this will involve observing treatment sessions to 
check adherence to the protocol. 
Qualitative interviews: 
The data from the interviews will be analysed using thematic analysis, using six steps proposed by Braun 
and Clarke transcribing the data, generating initial codes, searching for themes, reviewing themes, 
defining and naming themes and producing the report. Data will be transcribed from the audio 
recordings, whilst initial ideas are recorded. Then data will then be coded, before codes are grouped into 
themes. To aid the process of data analysis NVIVO 10 (or later version) software will be used, this 
computer programme is design for the analysis of qualitative data. It allows the collection, sorting and 
analysing of data from qualitative methods such as interviews.  
11.3. 
Sample Size Determination  
 
The sample size for the feasibility randomised controlled trial will be 40 participants, allowing for 20 
participants per group. Whitehead et al24 suggests that feasibility trials recruit 20 participants per group 
for an 80% powered main trial, assuming a small effect size of 0.1 to 0.3.  
12. DATA MANAGEMENT 
The plan for data management is outlined below. There is not a separate Data Management document in 
use for the study.  
12.1. 
Source Data 

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Source documents are where data are first recorded, and from which participants’ CRF data are 
obtained. These include, but are not limited to, hospital records (from which medical history and 
previous and concurrent medication may be summarised into the CRF), clinical and office charts, 
laboratory and pharmacy records, diaries, microfiches, radiographs, and correspondence. 
CRF entries will be considered source data if the CRF is the site of the original recording (e.g. there is no 
other written or electronic record of data).  All documents will be stored safely in confidential conditions. 
On all study-specific documents, other than the signed consent, the participant will be referred to by the 
study participant number/code, not by name. 
12.2. 
Access to Data 
 
Direct access will be granted to authorised representatives from the Sponsor and host institution for 
monitoring and/or audit of the study to ensure compliance with regulations. 
12.3. 
Data Recording and Record Keeping 
 
All trial data will be entered onto paper CRFs, then entered onto Microsoft Excel 2010 or newer or SPSS 
computer software (SPSS version 26.0 or newer) using password protected files on password protected 
OUH FT computers. Any study documents and data, such as the signed consent form will be stored in a 
lockable secure room in the Physiotherapy Research Unit at the Nuffield Orthopaedic Centre. The 
participants will be identified by a unique study specific participant number in any database. The name 
and any other identifying detail will NOT be included in any trial data electronic file. Qualitative 
transcripts will use pseudo initials and all identifiable information regarding people or place will be 
removed from transcripts. Personal data will be kept for 1 year after the study has finished and the study 
data will be stored on the OUH FT server for 5 years.   
For participants who agree in their Informed Consent to be contacted for future research, the consent 
form will be retained as the basis for retention of details and future approach. Those contact details will 
be held securely, separately from the research data, and kept updated. They will be held for an 
indeterminate period of time.   
13. QUALITY ASSURANCE PROCEDURES 

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The study may be monitored, or audited in accordance with the current approved protocol, GCP, 
relevant regulations and standard operating procedures.  
13.1. 
Risk assessment  
 
There will be no formal risk assessment plan due to the nature of this small, low risk feasibility pilot 
study.  
13.2. 
Study monitoring  
Not applicable  
13.3. 
Study Committees  
 
There will be no oversight committees since this study is small, logistically simple and low risk. 
14. PROTOCOL DEVIATIONS  
A study related deviation is a departure from the ethically approved study protocol or other study 
document or process (e.g. consent process or administration of study intervention) or from Good Clinical 
Practice (GCP) or any applicable regulatory requirements. Any deviations from the protocol will be 
documented in a protocol deviation form and filed in the study master file. 
15. SERIOUS BREACHES 
A “serious breach” is a breach of the protocol or of the conditions or principles of Good Clinical Practice 
which is likely to affect to a significant degree – 
 (a) the safety or physical or mental integrity of the trial subjects; or 
(b) the scientific value of the research. 
In the event that a serious breach is suspected the Sponsor must be contacted within 1 working day. In 
collaboration with the C.I., the serious breach will be reviewed by the Sponsor and, if appropriate, the 
Sponsor will report it to the approving REC committee and the relevant NHS host organisation within 
seven calendar days.  
16. ETHICAL AND REGULATORY CONSIDERATIONS 

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16.1. 
Declaration of Helsinki 
The Investigator will ensure that this study is conducted in accordance with the principles of the 
Declaration of Helsinki.  
16.2. 
Guidelines for Good Clinical Practice 
The Investigator will ensure that this study is conducted in accordance with relevant regulations and with 
Good Clinical Practice. 
16.3. 
Approvals 
Following Sponsor approval the protocol, informed consent form, participant information sheet will be 
submitted to an appropriate Research Ethics Committee (REC), and HRA (where required) and host 
institutions for written approval. 
The Investigator will submit and, where necessary, obtain approval from the above parties for all 
substantial amendments to the original approved documents. 
16.4. 
Other Ethical Considerations 
 
This study does not involve vulnerable participants or participants who are unable to consent for 
themselves. 
16.5. 
Reporting 
The CI shall submit once a year throughout the study, or on request, an Annual Progress report to the 
REC Committee, HRA (where required) host organisation, Sponsor and funder (where required). In 
addition, an End of Study notification and final report will be submitted to the same parties. 
16.6. 
Participant Confidentiality 
 
The study will comply with the General Data Protection Regulation (GDPR) and Data Protection Act 2018, 
which require data to be de-identified as soon as it is practical to do so. The processing of the personal 
data of participants will be minimised by making use of a unique participant study number only on all 
study documents and any electronic database(s), with the exception of the CRF, where participant initials 
may be added.  All documents will be stored securely and only accessible by study staff and authorised 
personnel. The study staff will safeguard the privacy of participants’ personal data. 

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16.7. 
Expenses and Benefits 
 
Reasonable travel expenses for any visits additional to normal care will be reimbursed on production of 
receipts, or a mileage allowance provided as appropriate. 
17. FINANCE AND INSURANCE 
17.1. 
Funding 
 
The project is funded by the Physiotherapy Research Unit, Nuffield Orthopaedic Centre. The Clinical 
Investigator is in receipt of a preparatory fellowship to cover their salary whilst conducting the study 
from the NIHR Biomedical Research Centre, based at Oxford University Hospitals Trust, Oxford.  
17.2. 
Insurance 
NHS bodies are legally liable for the negligent acts and omissions of their employees. If you are harmed 
whilst taking part in a clinical research study as a result of negligence on the part of a member of the 
study team this liability cover would apply. 
Non-negligent harm is not covered by the NHS indemnity scheme. The Oxford University Hospitals NHS 
Foundation Trust, therefore, cannot agree in advance to pay compensation in these circumstances. 
In exceptional circumstances an ex-gratia payment may be offered. 
17.3. 
Contractual arrangements  
 
Appropriate contractual arrangements will be put in place with all third parties.  
18. PUBLICATION POLICY 
 
The Investigators will be involved in reviewing drafts of the manuscripts, abstracts, press releases and 
any other publications arising from the study.  Authors will acknowledge that the study was supported by 
NIHR Biomedical Research Centre, based at Oxford University Hospitals Trust, Oxford. Authorship will be 
determined in accordance with the ICMJE guidelines and other contributors will be acknowledged. 

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19. DEVELOPMENT OF A NEW PRODUCT/ PROCESS OR THE GENERATION OF INTELLECTUAL 
PROPERTY  
 
Not applicable 
20. ARCHIVING 
 
Identifiable information will be kept for 1 year after the completion of the study. De-identified research 
data and research documents, and any research documents with personal information, such as consent 
forms, will be securely archived within the OUHFT for 5 years.   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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22. Appendix 1