What Are the Isokinetic Strength Outcomes and Self-reported Functional Outcomes (ATRS) at 12 Months Following Non-surgical Management of Achilles Tendon Rupture Using the SMART Protocol?
Conditions: Achilles Tendon Rupture
Sponsor: Liverpool University Hospitals NHS Foundation Trust

 
 
 
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ClinicalTrials.gov Cover Page 
Official Study Title: What are the isokinetic strength and self-reported functional 
outcomes (ATRS) at 12 months after non-surgical management of Achilles tendon 
rupture using the SMART protocol?  
NCT Number: NCT07391553  
Document: Study Protocol  
Version: 5  
Date: 06 February 2026  
Sponsor: Liverpool University Hospitals NHS Foundation Trust  
Responsible Party: Chief Investigator Jeff Morton 
 
 
 
 
 
 
 
 
 

 
 
 
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Study Acronym: Achilles Tendon Rupture: Patient Outcomes at 12 months 
Full Study title: “What are the isokinetic strength and self-reported functional outcomes (ATRS) at 12 months 
after non-surgical management of Achilles tendon rupture using the SMART protocol?” 
 
Version number and date: Version 5 Date: 06/02/2026 
IRAS Number: 357432 
SPONSORS Number: JRO-0663 
FUNDERS Number: NA 
 

 
 
 
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SIGNATURE PAGE 
The undersigned confirm that the following protocol has been agreed and accepted and that the Chief 
Investigator agrees to conduct the study in compliance with the approved protocol and will adhere to the 
principles outlined in the Declaration of Helsinki, the Liverpool University Hospitals NHS Foundation Trust 
SOPs, and other regulatory requirement. 
I agree to ensure that the confidential information contained in this document will not be used for any other 
purpose other than the evaluation or conduct of the investigation without the prior written consent of the 
Sponsor 
I also confirm that I will make the findings of the study publicly available through publication or other 
dissemination tools without any unnecessary delay and that an honest accurate and transparent account of the 
study will be given; and that any discrepancies from the study as planned in this protocol will be explained. 
 
For and on behalf of Liverpool University Hospitals NHS Foundation Trust 
 
Signature:  
......................................................................................................  
Date: ....../....../...... 
Name (please print): 
......................................................................................................  
 
Position: ...................................................................................................... 
 
 
 
Chief Investigator: 
Signature:  
 
 
 
Date: ....../....../...... 
Name: (please print): Jeff Morton 
 
 
 

 
 
 
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Table of Contents 
1. INTRODUCTION 
 
1.1 BACKGROUND 
 
2. STUDY OBJECTIVES 
 
3. STUDY DESIGN 
 
3.1 STUDY OUTCOME MEASURES 
 
4. PARTICIPANT ENTRY  
4.1 PRE‐REGISTRATION EVALUATIONS  
4.2 INCLUSION CRITERIA 
 
4.3 EXCLUSION CRITERIA 
 
4.4 WITHDRAWAL CRITERIA 
 
5. ADVERSE EVENTS 
 
5.1 DEFINITIONS 
 
5.2 REPORTING PROCEDURES 
 
6. ASSESSMENT AND FOLLOW‐UP 
 
7. STATISTICS AND DATA ANALYSIS 
 
8. REGULATORY ISSUES  
8.1 ETHICS APPROVAL  
8.2 CONSENT 
 
8.3 CONFIDENTIALITY 
 
8.4 INDEMNITY  
8.5 SPONSOR 
 
8.6 FUNDING 
 
MAIN SPONSOR: 

 
 
 
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FUNDERS:  
8.7 AUDITS AND INSPECTIONS 
9. STUDY MANAGEMENT 
10. END OF STUDY 
11. ARCHIVING 
12. PUBLICATION POLICY 
13. REFERENCES 
14. APPENDICES 
REC reference: 
KEY STUDY CONTACTS 
Chief Investigator 
Jeff Morton 
Tel: 0151 5293335 
Email: jeff.morton@liverpoolft.nhs.uk  
Study Co-ordinator 
Raymond Healy 
Tel: 0151 5293335 
Email: raymond.healy@liverpoolft.nhs.uk 
Sponsor 
Heather Rogers   
R&I Governance Manager 
Research Governance Committee Chair 
Liverpool University Hospitals NHS Foundation Trust 
Prescot St  
Liverpool  
Tel: 0151 706 3702 
Email: RGT@RLBUHT.nhs.uk  
 
Joint-sponsor(s)/co-sponsor(s)  
N/a 
Funder(s) 
N/a 
Key Protocol Contributors 
Raymond Healy 
Phone: 0151 529 3335 
Email: raymond.healy@liverpoolft.nhs.uk 

 
 
 
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Daniel Scarffe 
Phone: 0151 529 3335 
Email: daniel.scarffe@liverpoolft.nhs.uk 
 
Jeff Morton 
Phone: 0151 529 335 
Email: jeff.morton@liverpoolft.nhs.uk 
 
Evie Barclay 
Phone: 0151 529 3335 
Email: evie.barclay@liverpoolft.nhs.uk 
 
Michael Boyes 
Phone: 0151-706-3747 
Email: Michael.Boyes@liverpoolft.nhs.uk 
 
Committees 
n/a 
 
 
 
 
 
 
 
 
 
STUDY SUMMARY 
Study Title 
What are the isokinetic strength outcomes and self-
reported functional outcomes (ATRS) at 12 months 
following non-surgical management of Achilles tendon 
rupture using the SMART protocol? 

 
 
 
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Internal ref. no. (or short title) 
Achilles Tendon Rupture patient outcomes at 12 months 
Study Design 
Cross-sectional observational 
Study Participants 
A convenience sample of Achilles tendon rupture 
patients, managed in the orthopaedic department of 
Liverpool University Hospital NHS Foundation Trust will 
be recruited. 
Participants will be invited to attend Aintree University 
Hospital or Broadgreen Hospital and asked to complete 
the ATRS outcome measure to gain insight into the self-
perceived functional recovery from their Achilles tendon 
rupture injury after 12 months. Following a standardised 
warm up, they will complete isokinetic dynamometry 
testing where the outcomes of peak torque, work 
performed and Limb Symmetry Index will be recorded. 
Planned Size of Sample (if 
applicable) 
115 
Follow up duration (if applicable) 
Not applicable 
Planned Study Period 
2 years and 6 months 
Research Question/Aim(s) 
 
1. To determine the recovery of plantarflexor 
strength for NHS patients at 12 months after 
sustaining an Achilles tendon rupture injury, 
having been managed using the Swansea 
Morriston Achilles Rupture Treatment protocol. 
2. To determine the self-reported functional 
outcomes of NHS patients at 12 months after 
sustaining an Achilles tendon rupture injury, 
having been managed using the Swansea 
Morriston Achilles Rupture Treatment protocol. 
3. To investigate the relationship between ATRS 
scores and isokinetic strength scores for patients 
who have sustained an Achilles tendon rupture, 
managed with the SMART protocol after 12 
months. 
GLOSSARY OF ABBREVIATIONS 
AE  
Adverse event  
ATR 
Achilles tendon rupture 
CI  
Chief Investigator  
CRF  
Case Report Form  
HRA  
Health Research Authority  

 
 
 
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ICMJE  
The International Committee of Medical Journal Editors  
LUHFT 
Liverpool University Hospitals Foundation Trust 
NHS  
National Health Service  
NRES  
National Research Ethics Service  
PI  
Principal Investigator  
PIS  
Participant/ Patient Information Sheet  
REC  
Research Ethics Committee  
SAE  
Serious Adverse Event  
SMART 
Swansea Morriston Achilles Rupture Treatment 
UHLG 
University Hospitals of Liverpool Group 
 
KEYWORDS 
Achilles tendon rupture, Physiotherapy, orthopaedics, trauma, rehabilitation 
 
 
 

 
 
 
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STUDY FLOW CHART 
 

 
 
 
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1. INTRODUCTION 
1.1 BACKGROUND 
The Achilles tendon is the strongest and largest tendon in the human body, playing a critical role in 
plantarflexion and facilitating activities such as walking, running, and jumping. However, it is also the most 
frequently ruptured tendon (9). The injury and associated disability have a significant impact on patient quality 
of life and healthcare services (5). Achilles tendon ruptures are increasingly common, particularly among 
middle-aged recreational athletes, with an incidence estimated at 18 per 100,000 person-years (1,3).  
Historically, operative repair was considered the gold standard due to concerns regarding re-rupture risk and 
return to function; however, recent high-quality evidence suggests that non-surgical management may yield 
comparable outcomes when functional rehabilitation protocols are applied appropriately (3–5). 
The Swansea Morriston Achilles Rupture Treatment (SMART) protocol represents a structured, progressive 
approach to non-operative rehabilitation. It emphasizes early mobilisation, protected weight-bearing, and a 
gradual return to sport or high-level function through targeted strength and neuromuscular training (3). While 
short-term outcomes of non-surgical protocols have demonstrated promising results, there remains limited 
high-quality data on long-term isokinetic strength and patient-reported functional outcomes beyond six 
months (7). 
 
1.2 RATIONALE FOR CURRENT STUDY 
This study aims to evaluate isokinetic plantarflexor strength and self-reported functional outcomes at 12 
months following non-surgical management of Achilles tendon ruptures using the SMART rehabilitation 
protocol. By assessing both objective and subjective recovery metrics, we aim to contribute to the growing 
evidence base for evidence-informed, conservative Achilles tendon rehabilitation. 
Isokinetic strength testing offers a validated objective method to assess plantarflexor function and limb 
symmetry (2). When combined with validated patient-reported outcome measures such as the Achilles Tendon 
Total Rupture Score (ATRS) (6), this dual assessment may provide a comprehensive picture of recovery after 12 
months. Understanding these long-term outcomes is essential to guide rehabilitation progression, inform 
return-to-sport decisions, and support patient-centred care in non-operatively managed populations. 
Research question: 
What are the isokinetic strength outcomes and self-reported functional outcomes (ATRS) at 12 months 
following non-surgical management of Achilles tendon rupture using the SMART protocol? 
 
Hypothesis: 

 
 
 
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1. Patients with Achilles tendon ruptures managed non-surgically using the SMART protocol will 
demonstrate incomplete recovery of plantarflexor strength. This hypothesis will be tested by 
measuring plantarflexor strength using isokinetic dynamometry. Comparison will be made by testing 
the non-injured limb of the participating subjects. 
 
2. Patients with Achilles tendon ruptures managed non-surgically using the SMART protocol will report 
suboptimal functional outcomes at 12 months post-injury. This hypothesis will be tested by using the 
Achilles Tendon Total Rupture Score (ATRS) outcome measure. 
 
Secondary hypothesis: 
There will be a positive correlation between isokinetic plantarflexor strength and ATRS scores at 12 months 
post-injury. 
1.3 Scientific Review 
This protocol underwent independent scientific peer review by Professor Lyndon Mason (Consultant Foot & 
Ankle Surgeon), who evaluated the study design, methodology, and scientific validity. No concerns were raised 
regarding the protocol content. 
 
 
2. STUDY OBJECTIVES 
Primary: 
To evaluate plantarflexor muscle strength recovery in patients 12 months after non-surgical management of 
Achilles tendon ruptures using the SMART rehabilitation protocol, as measured by isokinetic dynamometry. 
To assess self-reported functional outcomes at 12 months post-injury using the Achilles Tendon Total Rupture 
Score (ATRS). 
Secondary: 
To explore the relationship between isokinetic strength measures and self-reported functional outcomes (i.e., 
correlation between LSI and ATRS). 
3. STUDY DESIGN 
This is a double-center, cross-sectional observational study conducted at Aintree University Hospital and 

 
 
 
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Broadgreen Hospital, targeting patients 12-15-month post-injury. To address the research question, we will 
invite patients for an optional one-off testing session 12-15 months following their Achilles tendon rupture 
injury. We will collect and analyse measures of plantarflexor muscle strength using isokinetic dynamometry and 
get patients to complete the ATRS outcome measure to gain insight into their functional recovery. Patients 
identified as eligible according to the protocol inclusion and exclusion criteria will be invited to participate in 
the study through informed written consent so that their clinical measurements can be used as research data 
for analysis. 
Isokinetic plantarflexor strength testing will be conducted using the Humac®/Norm dynamometer at 12-15 
months post-injury in line with usual care. All assessments will be performed by trained clinicians to ensure 
consistency across testing sessions. Participants will be instructed to refrain from vigorous lower limb activity 
for at least 24 hours prior to testing. 
A standardised warm-up will be completed, consisting of five minutes gentle cycling on a static exercise bike at 
a self-selected pace which will aim to increase heart rate and breathing rate whilst still being able to maintain a 
conversation. 
Following this, participants will be semi-reclined in the dynamometer chair with the knee flexed to 90°, as 
measured manually with a goniometer. The protocol for testing will be completed in accordance to the 
manufacturers advice. In brief, the ankle joint will be aligned with the axis of rotation of the dynamometer, 
typically corresponding to the lateral malleolus. Participants will be asked to wear flat soled shoes to minimise 
movement of the heel during the test. The foot will then be securely strapped to the footplate to minimize 
accessory movements, and the trunk, pelvis, and thigh will be stabilized using padded straps. Plantigrade of the 
ankle will be used to determine the ‘neutral’ position, with ranges of testing extending from 15° dorsiflexion 
through to 40° plantarflexion. 
Testing will consist of five maximal-effort concentric plantarflexion contractions at an angular velocity of 90°/s, 
five maximal-effort concentric plantarflexion contractions at an angular velocity of 30°/s, preceded by 7 sub-
maximal familiarisation repetitions. The uninvolved limb will be tested initially, followed by the involved limb. 
This set up and process has been previously investigated and demonstrated to be reliable for measures of peak 
torque (PT) and to a lesser degree, but still demonstrating moderate reliability, peak torque values relative to 
body weight (PT:BW) (Al Uzri et al, 2017) 
Outcome measures collected from the dynamometer will include peak plantarflexion torque (Nm), peak 
plantarflexion torque normalised to bodyweight (Nm/kg). A PT Limb Symmetry Index (LSI) will be calculated as 
(injured limb peak torque / uninjured limb peak torque) × 100 as an internal control measure to judge recovery 
of plantarflexor strength. PT:BW values will also be analysed as an external control measure in order to allow 
for comparison to other published findings in the literature. Testing will be discontinued if participants report 
pain or discomfort during the assessment. If coefficient variation exceeds 10%, the patient will be invited to 
perform the test again after a 15-minute rest period. 
 
Duration – 2 years and 6 months 

 
 
 
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Number of subjects: 115 
3.1 STUDY OUTCOME MEASURES 
The primary aim of this study is to assess the recovery of plantarflexor strength and self-reported functional 
outcomes in patients 12 months following non-surgical management of Achilles tendon rupture using the 
SMART protocol. To achieve this, both objective and subjective outcome measures will be collected during a 
single testing session. 
 
 
Primary Outcome Measures 
1. Isokinetic Plantarflexor Strength 
o 
Peak Torque (Nm) - The maximum rotational force produced by the plantarflexor muscles 
during an isokinetic contraction, measured in Newton-meters (Nm). This is a direct measure of 
muscle strength. In the context of Achilles tendon recovery, it reflects the ability of the calf 
muscles (gastrocnemius and soleus) to generate force through the tendon. 
o 
Peak Torque normalised to bodyweight (Nm/kg) - This metric adjusts for individual differences 
in body size, allowing for more accurate comparisons between participants. It is particularly 
useful in evaluating whether strength levels are appropriate relative to the individual's mass 
and functional demands. 
o 
Limb Symmetry Index (LSI) - This is a ratio comparing the performance of the injured limb to 
the uninjured limb, expressed as a percentage. A LSI ≥90% is considered indicative of 
satisfactory recovery (12). 
2. Achilles Tendon Total Rupture Score (ATRS) 
o 
A validated, self-reported questionnaire assessing symptoms and functional limitations related 
to Achilles tendon rupture. The ATRS consists of 10 items scored from 0 to 10, with a maximum 
score of 100 indicating full recovery. (7) 
Secondary Outcome Measures 
• 
Correlation between ATRS and Isokinetic Strength 
The relationship between subjective functional recovery (ATRS) and objective strength metrics (peak 
torque and LSI) will be assessed using Pearson’s correlation coefficient, assuming normal distribution 
of both variables. If normality assumptions are violated, Spearman’s rank correlation will be used as a 
non-parametric alternative. Normality will be tested using the Shapiro-Wilk test prior to correlation 

 
 
 
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analysis. 
Clinical Relevance 
These outcome measures were selected to provide a comprehensive view of recovery. Isokinetic testing offers 
a reliable and reproducible method for quantifying muscle performance, while the ATRS captures the patient’s 
perspective on their functional status. Together, these measures will help determine whether conservative 
management via the SMART protocol results in satisfactory recovery at 12 months post-injury. 
 
4. PARTICIPANT ENTRY 
4.1 PRE‐REGISTRATION EVALUATIONS 
Participants having sustained an Achilles tendon rupture will be identified using an existing database at 
Liverpool University Hospitals. Routinely, this injury is diagnosed clinically (6). This will take place at Aintree 
University Hospital and Broadgreen Hospital. 
4.2 Participant identification 
Participants will be identified by members of the research team. Participants meeting the inclusion criteria of 
the research protocol will be recruited by direct invitation. Potential participants will be initially screened via 
face-to-face interview to confirm eligibility. Once signed consent is obtained in writing, participants will 
proceed to be tested at Aintree University Hospital or Broadgreen Hospital. Potential participants will not be 
identified through Patient Identification Centres or recruited by publicity, posters, leaflets, adverts or 
websites. Muscle strength measures are taken routinely as part of the patient’s rehabilitation program. The 
study seeks to obtain informed consent from the patients so that the clinical data collected can be used as 
research.  
 
4.3 INCLUSION CRITERIA 
Inclusion Criteria: 
- Adults aged 18 and over 
- Confirmed Achilles tendon rupture 
- Non-surgical management via SMART protocol 
- 12-15 months post-injury 
- Ability to provide informed consent 
 
4.4 EXCLUSION CRITERIA 

 
 
 
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Exclusion Criteria: 
- Unable to provide consent 
- Prior Achilles tendon surgery or re-rupture 
- Neuromuscular disorders 
- Non-adherence to protocol 
- Previous contralateral history of achilles tendinopathy or rupture 
- Participant unable to tolerate IKD testing 
 
4.5 Participant Consent Process 
Informed consent will be gained by members of the research team at the NHS sites. 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 
 • the implications and constraints of the protocol 
 • the potential side effects and any risks involved in taking part 
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 (RH and DS), who are suitably qualified and 
experienced and have been authorised to do so by the NHS trust (LUHFT). A copy of the signed Informed 
consent will be given to the participants. The original signed form will be retained at the study site. 
 
4.5 WITHDRAWAL CRITERIA 
It will be clearly stated in the participant information sheet that the participant is free to withdraw from the 
study at any time for any reason without prejudice or impact on future care, and with no obligation to give the 
reason for withdrawal. The participant will be allowed as much time as required 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. 
4.6 Study Intervention 
This is a single-visit, cross-sectional observational study. Each participant will attend one research appointment 
at approximately 12 months (±3 month) following their Achilles tendon rupture. 
 
Procedures Involved: 

 
 
 
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1. Informed Consent 
o 
Participants will be provided with a Participant Information Sheet (PIS) in advance and will sign 
a consent form before any study procedures begin. 
2. Completion of the Achilles Tendon Total Rupture Score (ATRS) 
o 
A validated, self-reported questionnaire assessing symptoms and functional outcomes related 
to Achilles tendon rupture. 
3. Isokinetic Strength Testing 
o 
Performed using a Human Norm isokinetic dynamometer to assess plantarflexion peak torque 
at 30°/s and 90°/s. 
o 
The test will be performed on both the injured and uninjured side for comparison. 
o 
Results will include peak torque (Nm), Peak Torque normalised to bodyweight (Nm/kg) and 
Limb Symmetry Index (LSI). 
Duration and Number of Visits: 
• 
Number of visits: One 
• 
Total duration: Approximately 60–90 minutes per participant 
Randomisation: 
• 
Not applicable: This is an observational study with no intervention or group allocation. 
Sample Collection, Transport, and Storage: 
• 
No biological samples will be collected. 
• 
There is no collection of blood, tissue, or other bodily fluids. 
• 
As such, no transport or storage of samples is required. 
Data Storage: 
• 
Completed ATRS forms and strength test results will be anonymized and assigned a participant study 
ID. 
• 
Paper forms will be stored in a locked filing cabinets in the physiotherapy department at Aintree 
University Hospital and Broadgreen Hospital. 
• 
Digital data will be stored on a secure, password-protected NHS Trust server. 

 
 
 
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• 
Data will be retained in line with LUHFT research governance guidelines. 
 
 
 
5. ADVERSE EVENTS 
5.1 DEFINITIONS 
No significant issues are expected from the study. The testing procedure involved is performed as part of routine 
care and it not associated with known risks. There are no anticipated additional adverse effects inclusive of pain, 
discomfort, distress, or intrusion brought by participation in this study. The research will be stopped if evidence 
was presented to show that isokinetic calf musculature strength testing should not be used in this cohort due 
to safety reasons. 
5.2 REPORTING PROCEDURES 
Although this is a low-risk, non-interventional observational study, all adverse events (AEs) that occur during 
the study visit will be documented and monitored to ensure participant safety. Any unexpected issues arising 
during isokinetic testing (e.g., pain, discomfort, dizziness) will be recorded in the study file and reviewed by the 
Chief Investigator. 
If an adverse event is deemed to be: related to the study procedures (e.g., isokinetic testing), and unexpected 
(i.e., not anticipated based on routine clinical practice), then it will be reported to the Research Ethics 
Committee (REC) and Sponsor in accordance with Health Research Authority (HRA) guidelines. 
All adverse events will be recorded in the Case Report Form (CRF) and reviewed by the Chief Investigator. 
 
5.2.1 Non serious Adverse Events 
Non-serious adverse events (e.g., transient muscle soreness, mild discomfort) will be recorded in the CRF and 
monitored by the research team. These events will be reviewed periodically to identify any patterns or 
concerns. 
Participants will be advised to report any discomfort or issues experienced during or after testing. If necessary, 
the testing session will be discontinued, and appropriate clinical care will be provided. 
 
5.2.2 Serious Adverse Events (SAEs)  

 
 
 
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Although unlikely in this study, any Serious Adverse Events (SAEs)—defined as events that result in death, are 
life-threatening, require hospitalisation, or result in significant disability—will be reported to the Sponsor and 
REC if they are: 
• 
Related to the study procedures, and 
• 
Unexpected. 
SAEs will be reported within 24 hours of the research team becoming aware of the event using the appropriate 
SAE reporting form. The Chief Investigator will assess causality and expectedness. All related and unexpected 
SAEs will be reported to the REC within 15 days. 
Contact for SAE reporting: 
• 
Chief Investigator: Jeff Morton 
• 
Email: jeff.morton@liverpoolft.nhs.uk 
• 
Tel: 0151 529 3335 
Sponsor Contact: 
• 
Mrs Heather Rogers 
• 
Email: RGT@liverpoolft.nhs.uk 
• 
Tel: 0151 706 2000 
 
6. ASSESSMENT AND FOLLOW‐UP 
Assessment procedures have been detailed above and as all testing can be completed in a single visit, there is 
no indication for follow up.  
7. STATISTICS AND DATA ANALYSIS 
7.2.1  Size of sample 
Based on a paired t-test comparing isokinetic plantarflexor strength between injured and uninjured limbs, a 
sample size calculation was completed with 80% statistical power and a significance level (alpha) of 0.05 was 
chosen. The analysis determined that 92 participants are required to detect a clinically meaningful difference 
in strength recovery. To account for potential dropouts or incomplete data, we plan to recruit a total of 115 
participants (20% drop out). 
7.2.2  Sampling technique 
This study will employ a convenience sampling strategy. Participants will be identified from a pre-existing 
clinical database of patients who have sustained an Achilles tendon rupture and were managed non-surgically 
using the SMART protocol at Liverpool University Hospitals NHS Foundation Trust. Eligible individuals will be 

 
 
 
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invited to participate in a one-off assessment session 12-15 months post-injury. 
Convenience sampling is appropriate for this observational study due to the specific inclusion criteria and the 
availability of a well-defined patient cohort. This approach allows for efficient recruitment of participants who 
meet the study requirements and have already undergone standardised rehabilitation. While convenience 
sampling may introduce selection bias, the use of objective outcome measures (isokinetic dynamometry) and 
validated patient-reported outcomes (ATRS) helps to mitigate this limitation and ensure data quality. 
The rationale for this sampling strategy aligns with the study’s methodological framework, which aims to 
describe normative recovery outcomes in a real-world NHS setting. The findings will inform clinical practice and 
future research by providing benchmark data for patients managed conservatively following Achilles tendon 
rupture. 
 
8. REGULATORY ISSUES 
8.1 ETHICS APPROVAL 
The Chief Investigator has obtained approval from the Research Ethics Committee and Health Research 
Authority (HRA) approval. The study will be submitted to each proposed research site for Confirmation of 
Capacity and Capability. The study will be conducted in accordance with the recommendations for physicians 
involved in research on human subjects adopted by the 18th World Medical Assembly, Helsinki 1964 and later 
revisions. 
8.2 CONSENT 
Informed consent will be gained by members of the research team at the relevant NHS site. 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 
 • the implications and constraints of the protocol 
 • the potential 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 or impact on future care, and with no obligation to give the reason for withdrawal. The participant will 
be allowed as much time as required 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 (RH & DS), who are suitably qualified and experienced 

 
 
 
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and have been authorized to do so by the lead NHS trust (Liverpool University Hospitals NHS Foundation Trust). 
A copy of the signed Informed Consent will be given to the participants. The original signed form will be retained 
at the study site. 
8.3 CONFIDENTIALITY 
The Chief Investigator will preserve the confidentiality of participants taking part in the study and will 
abide by the Data Protection Act (GDPR 2018).  
The custodians of data at the NHS research site will be the Mr. Raymond Healy and Mr. Daniel Scarffe. The 
confidentiality of personal data of patients participating within the study will be maintained in accordance with 
the NHS Code of Practice for Confidentiality. Personal data will be held within the patient's clinical notes, which 
are securely stored within the appropriate NHS department in manual files and on secured computer servers. 
Access to personal data is restricted to the medical team treating the patient and those authorized by Liverpool 
University Hospital NHS Trust. The data is not transferred outside of the NHS systems that would normally apply 
as part of the care that the patient receives. Personal data held within manual files will be stored in locked 
cabinets. Access to the rooms in which the data is stored is restricted to authorised NHS employees. Personal 
data held in electronic format will be maintained on secure NHS computer servers. Computers are password 
protected and access is restricted to authorised NHS employees. Data generated by the study will be stored on 
NHS computers which are password protected by secured servers. Access to the data on computers is restricted 
by password protection to those within the study team. Data will be pseudoanonymised by the research team 
by removal of the name, address, full post code or any other details that would lead to the identification of the 
patient. Research data will be stored on a password protected database. 
Participant identifiable data will not be accessible to researchers outside of the direct clinical care team and 
those with specific authorisation from Liverpool University Hospitals NHS Foundation Trust. The name and any 
other identifying detail will NOT be included in any study data electronic file. No personal data will be 
disseminated in any format outside the direct care team and NHS data management systems. 
Pseudoanonymised data on hospital computers will be password protected. Archiving for study will be 5 years, 
as per Liverpool University Hospitals NHS Foundation Trust standard operating procedure. 
 
8.4 INDEMNITY 
The Liverpool University Hospitals NHS Foundation Trust will provide NHS Indemnity Cover as the sponsor of 
this study. 
8.5 SPONSOR 
The Liverpool University Hospitals NHS Foundation Trust will act as Sponsor for this study. It is recognised that 
as an employee of the Trust the Chief Investigator has been delegated specific duties, as detailed in the 
Sponsorship Approval letter and the CI agreement. 

 
 
 
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8.6 FUNDING 
There is no external funding for this study. 
8.7 AUDITS 
The study may be subject to risk-based monitoring, inspection and audit by the Liverpool University Hospitals 
NHS Foundation Trust under their remit as sponsor and other regulatory bodies to ensure adherence to GCP 
and the NHS Research Governance Framework for Health and Social Care (2nd edition). 
9. STUDY MANAGEMENT 
The day‐to‐day management of the study will be coordinated by the Principal Investigators at Liverpool University 
Hospitals NHS Foundation Trust. All research data will be securely managed using REDCap (research Electronic 
Data Capture), a secure web-based application designed for data collection in clinical research. REDCap is hosted 
on NHS-approved servers and complies with data protection regulations including UK GDPR.  
Access to the REDCap database will be restricted to authorised study personnel only. Each user will have 
individual login credentials, and audit trails will be maintained to track data entry and modifications. REDCap will 
be used to store pseudoanonymised participant data, including questionnaire responses and isokinetic strength 
testing results. 
This system will ensure high data integrity, secure storage, and efficient management of study data throughout 
the research project. 
The Trust Patient Experience and Engagement Team reviewed the study protocol and provided input into 
participant-facing materials 
 
 
10. END OF STUDY 
The study will be deemed complete when all data collection is completed and the analyses have been fully 
performed, and data has been locked which is anticipated to be after 2 years and 6 months from the start of 
the study. End of study declaration and final study report will be submitted to HRA/REC and sponsor notifying 
them of the conclusion of the study. All data will be held electronically.  
All documents will be archived. Data will be archived for 5 years after the end of the study in line with the 
sponsor’s standard operating procedure on archiving. 
 
 

 
 
 
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11. ARCHIVING 
Data and all appropriate documentation will be stored for 5 years, as per Liverpool University Hospitals NHS 
Foundation Trust standard operating procedures. 
12. PUBLICATION POLICY 
The final study report will be co-authored by the Chief Investigator of the study Jeff Morton and all other 
members of the research team. Authorship of manuscripts produced to disseminate the outcomes of the 
study, including poster and oral presentations at appropriate conferences or as research articles in peer-
reviewed journals will be determined according to The International Committee of Medical Journal Editors 
(ICMJE) recommendations that an author should meet all four of the following criteria to qualify for authorship 
of a manuscript: 
1. Substantial contributions to the conception or design of the work; or the acquisition, analysis, or 
interpretation of data for the work  
2. Drafting the work or revising it critically for important intellectual content  
3. Final approval of the version to be published  
4. Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or 
integrity of any part of the work are appropriately investigated and resolved. 
 
 
 
 
 
 
 
 

 
 
 
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13. REFERENCES 
APA-Formatted Reference List: 
1. Brumann, M., Baumbach, S. F., Mutschler, W., & Polzer, H. (2014). Accelerated rehabilitation following 
Achilles tendon repair after acute rupture—Development of an evidence-based treatment protocol. 
Foot & Ankle International, 35(6), 607–614. https://doi.org/10.1177/1071100714528807 
 
2. Chester, R., Costa, M. L., Shepstone, L., & Donell, S. T. (2003). Reliability of isokinetic dynamometry in 
assessing plantarflexion torque following Achilles tendon rupture. Foot & ankle international, 24(12), 
909–915. https://doi.org/10.1177/107110070302401207 
 
3. Hutchison, A. M., Topliss, C., Beard, D., Evans, R. M., & Williams, P. (2015). The treatment of a rupture 
of the Achilles tendon using a dedicated management programme. The Bone & Joint Journal, 97(4), 
510-515. 
 
 
4. Huttunen, T. T., Kannus, P., Rolf, C., Felländer-Tsai, L., & Mattila, V. M. (2014). Acute Achilles tendon 
ruptures: Incidence of injury and surgery in Finland between 1997 and 2011. The American Journal of 
Sports Medicine, 42(10), 2419–2423. https://doi.org/10.1177/0363546514540599 
 
5. Khan, R.J.K., Fick, D., Keogh, A., Crawford, J., Brammar, T., & Parker, M. (2005). Treatment of acute 
Achilles tendon ruptures: a meta-analysis of randomized, controlled trials. The Journal of Bone and Joint 
Surgery-American Volume, 87(10), 2202-2210. https://doi.org/10.2106/JBJS.D.02049 
 
6. Maffulli, N., Waterston, S. W., Squair, J., Reaper, J., & Douglas, A. S. (1999). Changing incidence of 
Achilles tendon rupture in Scotland: A 15-year study. Clinical Journal of Sport Medicine, 9(3), 157–160. 
https://doi.org/10.1097/00042752-199907000-00006 
 
7. Nilsson-Helander, K., Thomeé, R., Silbernagel, K. G., Thomeé, P., Faxén, E., Eriksson, B. I., & Karlsson, J. 
(2007). The Achilles tendon Total Rupture Score (ATRS): Development and validation. The American 
Journal of Sports Medicine, 35(3), 421–426. https://doi.org/10.1177/0363546506294856 
 
8. Nilsson, N., Nilsson Helander, K., Hamrin Senorski, E., Holm, A., Karlsson, J., Svensson, M., & Westin, O. 

 
 
 
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(2020). The economic cost and patient-reported outcomes of chronic Achilles tendon ruptures. Journal 
of Experimental Orthopaedics, 7, 1-6. 
 
 
9. Olsson, N., Silbernagel, K. G., Eriksson, B. I., Sansone, M., Nilsson-Helander, K., Thomeé, R., & Karlsson, 
J. (2013). Stable surgical repair with accelerated rehabilitation versus nonoperative treatment for acute 
Achilles tendon ruptures: A randomized controlled study. The American Journal of Sports Medicine, 
41(12), 2867–2876. https://doi.org/10.1177/0363546513502301 
 
10. Silbernagel, K. G., Steele, R., & Manal, K. (2012). Deficits in heel-rise height and Achilles tendon 
elongation occur in patients recovering from an Achilles tendon rupture. The American Journal of 
Sports Medicine, 40(7), 1564–1571. https://doi.org/10.1177/0363546512447926 
 
11. Soroceanu, A., Sidhwa, F., Aarabi, S., Kaufman, A., & Glazebrook, M. (2012). Surgical versus nonsurgical 
treatment of acute Achilles tendon rupture: A meta-analysis of randomized trials. The Journal of Bone 
and Joint Surgery. American Volume, 94(23), 2136–2143. https://doi.org/10.2106/JBJS.K.00917 
 
12. Sukanen, M., Auranen, A., Mattila, K. T., & Laine, H. (2021). Early predictors of recovery from 
nonoperatively treated Achilles tendon rupture: 1-year follow-up study. Scandinavian Journal of 
Medicine & Science in Sports, 31(3), 603–611. https://doi.org/10.1111/sms.14700 
 
 
13. Thevendran, G., Sarraf, K. M., Patel, N. K., Sadri, A., & Rosenfeld, P. (2013). The ruptured Achilles 
tendon: a current overview from biology of rupture to treatment. Musculoskeletal surgery, 97, 9-20. 
 
14.  Willits, K., Amendola, A., Bryant, D., Mohtadi, N., Giffin, J. R., Fowler, P., Kean, C. O., Kirkley, A., & 
Jenkins, P. (2010). Operative versus nonoperative treatment of acute Achilles tendon ruptures: A 
multicenter randomized trial using accelerated functional rehabilitation. The Journal of Bone and Joint 
Surgery. American Volume, 92(17), 2767–2775. https://doi.org/10.2106/JBJS.I.01401