Achilles Tendon Rupture Patient Outcomes at 12 Months (ATR-12)

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?

Achilles tendon rupture is a common injury that can significantly impact strength, function, and quality of life. While non-surgical management using structured rehabilitation protocols such as the Swansea Morriston Achilles Rupture Treatment (SMART) protocol is increasingly adopted, there is limited evidence on long-term recovery outcomes, particularly beyond six months.

This study aims to evaluate recovery at 12-15 months following non-surgical management of Achilles tendon rupture in an NHS population. Participants will attend a single study visit during which plantarflexor muscle strength will be assessed using isokinetic dynamometry, and patient-reported outcomes will be collected using the Achilles Tendon Total Rupture Score (ATRS) and EQ-5D-5L questionnaire. Achilles Tendon Resting Angle (ATRA) will also be measured to provide an estimate of tendon elongation.

The primary objectives are to quantify plantarflexor strength recovery and self-reported functional outcomes. Secondary analyses will explore associations between strength, tendon elongation, quality of life, return to sport, and pre-injury symptoms.

This cross-sectional observational study will recruit adult patients managed non-surgically with the SMART protocol from Liverpool University Hospitals NHS Foundation Trust. Findings will provide clinically relevant data on long-term recovery following conservative treatment and may inform rehabilitation strategies and return-to-activity decision-making.

Study Overview

• Status: Not yet recruiting
• Conditions: Achilles Tendon Rupture
• Intervention / Treatment: Other: Non-Surgical Management Using the SMART Protocol

Detailed Description

This study is a cross-sectional observational investigation designed to evaluate objective and patient-reported recovery outcomes following non-surgical management of Achilles tendon rupture using the Swansea Morriston Achilles Rupture Treatment (SMART) rehabilitation protocol. The study is conducted within a National Health Service (NHS) setting at Liverpool University Hospitals NHS Foundation Trust.

Participants will be identified from an established clinical database of patients who have sustained an Achilles tendon rupture and completed non-operative rehabilitation. Eligible individuals will be invited to attend a single assessment session at 12-15 months post-injury. This time point has been selected to reflect longer-term recovery, as previous literature has predominantly focused on early and mid-term outcomes.

Study Procedures and Data Collection During the study visit, participants will undergo a comprehensive assessment including objective, clinical, and patient-reported measures. Isokinetic dynamometry will be used to quantify plantarflexor muscle performance under controlled conditions. Testing will be standardised, including participant positioning, joint alignment, range of motion, and angular velocities. Outcome variables will include peak torque and torque relative to body mass, allowing both within-participant and between-participant comparisons.

Achilles tendon structural characteristics will be assessed indirectly using the Achilles Tendon Resting Angle (ATRA), a clinically applicable proxy for tendon elongation. Measurements will be taken bilaterally using a standardised protocol with repeated trials to improve reliability, and side-to-side differences will be calculated.

Participants will also complete validated patient-reported outcome measures to capture functional status and general health. Additional contextual variables, including return-to-sport status and pre-injury Achilles symptoms, will be recorded to enable exploratory subgroup analyses.

Data Management and Quality Assurance All study data will be recorded using a structured case report form and stored within a secure, NHS-hosted electronic data capture system (REDCap). Data will be pseudonymised at the point of entry, with each participant assigned a unique study identifier. Identifiable information will be stored separately from research data and accessible only to authorised study personnel.

Data quality will be maintained through predefined validation rules within the data capture system, including range checks and logical consistency checks across related variables. Regular data monitoring will be conducted by the research team to ensure completeness and accuracy. Source data verification may be undertaken by comparing selected data fields against original clinical records where necessary.

A data dictionary will be maintained to define all study variables, including measurement units, coding structures, and allowable ranges. Standard Operating Procedures (SOPs) will guide all aspects of study conduct, including participant identification, data collection, data entry, and data storage, ensuring consistency across sites.

Sample Size Justification The sample size has been determined based on statistical considerations for detecting meaningful differences in strength between limbs as well as associations between objective and patient-reported outcomes. Allowance has been made for incomplete data to ensure adequate statistical power for primary analyses.

Statistical Analysis Plan Data analysis will be conducted using established statistical software. Continuous variables will be assessed for normality and summarised using appropriate descriptive statistics. Associations between variables will be explored using correlation analyses, with parametric or non-parametric methods applied as appropriate. Comparative analyses may be performed for exploratory subgroup comparisons (e.g., return to sport categories or presence of pre-injury symptoms).

All analyses will be interpreted within the context of an observational study design, and findings will be considered hypothesis-generating.

Handling of Missing Data Missing data will be assessed to determine patterns and potential sources (e.g., non-response, incomplete testing). Where feasible, analyses will be conducted using available data without imputation. The extent and impact of missing data will be reported transparently, and sensitivity analyses may be undertaken if appropriate.

Study Oversight and Governance The study is conducted in accordance with Good Clinical Practice (GCP), the Declaration of Helsinki, and NHS research governance frameworks. All study personnel are trained in study procedures to ensure standardisation. Data handling complies with the UK General Data Protection Regulation (GDPR) and Data Protection Act 2018.

• Study Type: Observational
• Enrollment (Estimated): 115

Contacts and Locations

• Study Contact: Name: Raymond Healy, BSc. (Hons) Physiotherapy; Phone Number: 0151 529 3335; Email: raymond.healy@liverpoolft.nhs.uk
• Study Contact Backup: Name: Jeff Morton, Bsc. (Hons) Physiotherapy; Phone Number: 0151 706 2760; Email: jeff.morton@liverpoolft.nhs.uk

Study Locations

• United Kingdom
  • Merseyside
    • Liverpool, Merseyside, United Kingdom, L14 3LB
      • Broadgreen Hospital Physiotherapy department
      • Contact: Raymond Healy, BSc. (Hons) Physiotherapy; Phone Number: 0151 529 3335; Email: raymond.healy@liverpoolft.nhs.uk
      • Contact: Jeff Morton, Bsc. (Hons) Physiotherapy; Phone Number: 0151 706 2760; Email: jeff.morton@liverpoolft.nhs.uk
    • Liverpool, Merseyside, United Kingdom, L9 7 AL
      • Aintree University Hospital Therapies department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adults who previously sustained an Achilles tendon rupture and were treated non-surgically using the SMART rehabilitation protocol within Liverpool University Hospitals NHS Foundation Trust. Eligible participants are identified from an existing clinical database and represent patients 12-15 months post-injury who completed standard physiotherapy rehabilitation. All participants are drawn from routine NHS orthopaedic and physiotherapy services at Aintree and Broadgreen Hospitals.

Description

Inclusion Criteria:

Aged 18 years or older at the time of recruitment

• Have a confirmed diagnosis of Achilles tendon rupture, diagnosed clinically and recorded within the NHS clinical database
• Have been managed non-surgically using the SMART (Swansea Morriston Achilles Rupture Treatment) rehabilitation protocol
• Be between 12 and 15 months post-injury at the time of study assessment
• Be able and willing to provide written informed consent to participate in the study

Exclusion Criteria:

• Unable to provide informed consent
• Have previously undergone surgical repair of the Achilles tendon or experienced a re-rupture
• Have a neuromuscular or neurological condition that could affect lower limb strength or function
• Did not follow the SMART rehabilitation protocol for non-surgical management
• Have a history of Achilles tendinopathy or rupture in the contralateral (uninjured) limb
• Are unable to tolerate isokinetic strength testing due to pain, discomfort, or other medical reasons

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Non-Surgically Managed Achilles Tendon Rupture Cohort; Adults who sustained an Achilles tendon rupture and were managed non-surgically using the SMART rehabilitation protocol within Liverpool University Hospitals NHS Foundation Trust. All participants are 12-15 months post-injury at the time of assessment.	Other: Non-Surgical Management Using the SMART Protocol; Participants previously received standard non-surgical treatment for Achilles tendon rupture following the SMART (Swansea Morriston Achilles Rupture Treatment) functional rehabilitation protocol as part of routine NHS care. No interventions are assigned as part of this study; all data are collected at a single follow-up visit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Achilles Tendon Total Rupture Score	A validated patient-reported outcome measure assessing symptoms and functional limitations following Achilles tendon rupture. Scores range from 0 to 100, with higher scores indicating better perceived recovery.	12-15 months post-injury (single study visit)
Isokinetic plantarflexor strength	Peak torque (Nm): the maximum force produced by the calf muscles during a contraction; Peak torque normalised to bodyweight (Nm/kg): to allow comparison between individuals of different body sizes; Limb Symmetry Index (LSI): the strength of the injured limb expressed as a percentage of the uninjured limb	12-15 months post-injury (single study visit)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between isokinetic strength and ATRS	The relationship between subjective functional recovery (ATRS) and objective strength measures (peak torque and Limb Symmetry Index) will be assessed using Pearson's correlation coefficient, assuming normal distribution of the data. If normality assumptions are not met, Spearman's rank correlation coefficient will be used. Normality will be assessed using the Shapiro-Wilk test.	12-15 months post injury
Health-related quality of life	Health-related quality of life will be assessed using the EQ-5D-5L questionnaire, including both index scores and visual analogue scale (VAS) scores. These will be described using appropriate descriptive statistics.	12-15 months post injury
Achilles Tendon Resting Angle	The Achilles Tendon Resting Angle will be measured in both limbs. Side-to-side differences will be calculated and described to provide an indication of tendon elongation	12-15 months post injury
Return to sport/activity status	Participants will be categorised based on their return to activity: Return to same level and frequency; Return to same level at reduced frequency; Return to a lower level; No return to sport These categories will be described using descriptive statistics and used for exploratory comparisons of outcomes.	12-15 months post injury
Pre-injury Achilles symptoms	The presence and duration of Achilles pain prior to rupture will be recorded and summarised descriptively. Exploratory comparisons may be performed to assess whether pre-injury symptoms are associated with differences in recovery outcomes.	12-15 months post injury

Collaborators and Investigators

• Sponsor: Liverpool University Hospitals NHS Foundation Trust
• Investigators: Study Chair: Jeff Morton, BSc. (Hons) Physiotherapy, Liverpool University Hospitals NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): January 1, 2029

Study Registration Dates

• First Submitted: January 25, 2026
• First Submitted That Met QC Criteria: February 2, 2026
• First Posted (Actual): February 6, 2026

Study Record Updates

• Last Update Posted (Actual): July 6, 2026
• Last Update Submitted That Met QC Criteria: July 1, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: trauma; rehabilitation; Physiotherapy; Achilles tendon rupture; orthopaedics
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: JRO-0663 (Other Identifier: LIVERPOOL HEALTH PARTNERS JOINT RESEARCH OFFICE); IRAS ID: 357432 (Other Identifier: Health Research Authority)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared. Only aggregated, anonymised results will be published. This is consistent with participant consent and NHS data governance requirements

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No