Achilles Tendon RuptureATR-12NCT07391553
Achilles Tendon Rupture Patient Outcomes at 12 Months
An observational study of Achilles Tendon Rupture, run by Liverpool University Hospitals NHS Foundation Trust at 2 sites in United Kingdom.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Achilles Tendon Rupture
- What is being tested?
- Non-Surgical Management Using the SMART Protocol
- How many people
- 115 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 8 Sep 2026to 1 Jan 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom2 sites, 2 recruiting
- Recruiting
Broadgreen Hospital Physiotherapy department
Liverpool, Merseyside, L14 3LB
Jeff Morton, Bsc. (Hons) Physiotherapy, 0151 706 2760, jeff.morton@liverpoolft.nhs.uk
Raymond Healy, BSc. (Hons) Physiotherapy, 0151 529 3335, raymond.healy@liverpoolft.nhs.uk
- Recruiting
Aintree University Hospital Therapies department
Liverpool, Merseyside, L9 7 AL
Raymond Healy, Bsc. (Hons) Physiotherapy, 0151 529 3335, raymond.healy@liverpoolft.nhs.uk
Jeff Morton, BSc. (Hons) Physiotherapy, 0151 529 3335, jeff.morton@liverpoolft.nhs.uk
About this study
Official 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?
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.
Read more
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.
Read the 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.
- Conditions
- Achilles Tendon Rupture
- Being tested
- Non-Surgical Management Using the SMART Protocol
- Keywords
- Achilles tendon rupture, Physiotherapy, orthopaedics, trauma, rehabilitation
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Surgical Management Using the SMART ProtocolOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Non-Surgical Management Using the SMART Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Isokinetic plantarflexor strength - Peak Torque
Peak plantarflexion torque will be measured using isokinetic dynamometry. Peak torque (Newton metres [Nm]) represents the maximum force generated by the plantarflexor muscles during a maximal voluntary contraction.
Unit of Measure: Newton metres (Nm)
Minimum value: 0 Nm
Maximum value: No fixed maximum value
Higher values indicate: Greater plantarflexor muscle strength (better outcome)
Measured: 12-15 months post-injury (single study visit)
Isokinetic Plantarflexion Strength Normalised to Body Weight
Peak plantarflexion torque normalised to body weight, measured using isokinetic dynamometry. Results are expressed as Newton metres per kilogram (Nm/kg) to facilitate comparison of plantarflexor muscle strength between individuals of different body sizes.
Unit of Measure: Newton metres per kilogram (Nm/kg)
Minimum Value: 0 Nm/kg
Maximum Value: No fixed maximum value
Higher values indicate: Greater plantarflexor muscle strength relative to body weight (better outcome)
Measured: 12-15 months post injury
Isokinetic Plantarflexion Strength Limb Symmetry Index (LSI)
Limb Symmetry Index (LSI) for isokinetic plantarflexion strength. LSI is calculated as the peak torque of the injured limb divided by the peak torque of the uninjured limb and expressed as a percentage. An LSI of 100% indicates equal strength between limbs, while values below 100% indicate a strength deficit in the injured limb.
Unit of Measure: Percent (%)
Minimum Value: 0%
Maximum Value: No fixed maximum value
Higher values indicate: Greater symmetry between injured and uninjured limbs and therefore a better outcome.
Measured: 12-15 months post injury
Achilles Tendon Total Rupture Score
The Achilles Tendon Total Rupture Score (ATRS) is a validated patient-reported outcome measure assessing symptoms, physical activity, and functional limitations following Achilles tendon rupture. Scores range from 0 to 100, with higher scores indicating better perceived recovery and fewer symptoms.
Time Frame: 12-15 months post-injury (single study visit)
Unit of Measure: Points
Minimum Value: 0
Maximum Value: 100
Higher scores indicate: Better outcome (fewer symptoms and greater function)
Lower scores indicate: Worse outcome (more symptoms and greater functional limitation)
Measured: 12-15 months post-injury (single study visit)
Secondary outcomes (7)
Correlation Between Achilles Tendon Total Rupture Score and Peak Plantarflexion Torque
Correlation between subjective recovery measured by the Achilles Tendon Total Rupture Score (ATRS) and objective plantarflexor muscle strength measured as peak plantarflexion torque during isokinetic dynamometry.
Unit of Measure: Correlation coefficient (r)
Minimum Value: -1
Maximum Value: 1
Interpretation: Values closer to ±1 indicate a stronger relationship between ATRS and peak plantarflexion torque. Values closer to 0 indicate a weaker relationship.
Measured: 12-15 months post injury
Correlation Between Achilles Tendon Total Rupture Score and Plantarflexion Strength Limb Symmetry Index
Correlation between subjective recovery measured by the Achilles Tendon Total Rupture Score (ATRS) and objective plantarflexion strength symmetry measured using the Limb Symmetry Index (LSI).
Time Frame: 12-15 months post-injury (single study visit)
Unit of Measure: Correlation coefficient (r)
Minimum Value: -1
Maximum Value: 1
Interpretation: Values closer to ±1 indicate a stronger relationship between ATRS and Limb Symmetry Index. Values closer to 0 indicate a weaker relationship.
Measured: 12-15 months post injury
Health-related quality of life - EuroQol Five-Dimension Five-Level Questionnaire (EQ-5D-5L) Summed Dimension Score
Health-related quality of life will be assessed using the EuroQol 5-Dimension, 5-Level (EQ-5D-5L) Questionnaire.
The EuroQol Five-Dimension Five-Level Questionnaire (EQ-5D-5L) is a patient-reported measure of health-related quality of life consisting of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated on a five-level scale from no problems to extreme problems.
Minimum value: 5 Maximum value: 25 Direction of scale: Lower scores indicate a better outcome (fewer health problems); higher scores indicate a worse outcome (more severe health problems).
Measured: 12-15 months post injury
Health related quality of life - EuroQol Visual Analogue Scale
The EuroQol Visual Analogue Scale (EQ VAS) is a self-reported measure of overall health status. Participants rate their current health on a vertical visual analogue scale ranging from 0 ("the worst health you can imagine") to 100 ("the best health you can imagine").
Minimum value: 0 Maximum value: 100 Higher scores indicate: Better self-rated health status Lower scores indicate: Worse self-rated health status
Measured: 12-15 months post injury
Achilles Tendon Resting Angle (ATRA)
The Achilles Tendon Resting Angle (ATRA) is a goniometric measure used as an indirect assessment of Achilles tendon elongation. Side-to-side difference in ATRA between the injured and uninjured limbs will be measured in degrees. ATRA does not have fixed minimum or maximum possible values. Higher values indicate less tendon elongation (better outcome), while lower values indicate greater tendon elongation (worse outcome).
Time Frame: 12-15 months post-injury (single study visit)
Unit of Measure: Degrees (°)
Minimum Value: No fixed minimum value
Maximum Value: No fixed maximum value
Higher values indicate: Less tendon elongation (better outcome)
Lower values indicate: Greater tendon elongation (worse outcome)
Measured: 12-15 months post injury
Return to sport/activity status
Return to sport/activity status assessed at follow-up. Participants will be categorised according to their highest level of return to pre-injury sport or physical activity:
Return to same level and frequency Return to same level at reduced frequency Return to a lower level No return to sport/activity
Time Frame: 12-15 months post-injury (single study visit)
Unit of Measure: Category
Minimum Value: No return to sport/activity
Maximum Value: Return to same level and frequency
Higher categories indicate: Greater return to pre-injury sport/activity participation (better outcome)
Measured: 12-15 months post injury
Presence of Pre-Injury Achilles Tendon Symptoms
Description: Presence of Achilles tendon pain or symptoms prior to tendon rupture, assessed by participant self-report. Participants will be classified according to whether Achilles tendon symptoms were present before the rupture.
Time Frame: Assessed at 12-15 months post-injury (single study visit; recall of pre-injury symptoms)
Unit of Measure: Category
Categories:
No pre-injury Achilles symptoms Pre-injury Achilles symptoms present
Interpretation: Presence of pre-injury symptoms may indicate preceding Achilles tendon pathology.
Measured: 12-15 months post injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start8 Sep 2026
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Achilles Tendon RuptureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 115 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liverpool University Hospitals NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Raymond Healy, Liverpool University Hospitals NHS Foundation Trust
- Investigators
- Jeff Morton, BSc. (Hons) Physiotherapy, Study chair, Liverpool University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07391553
- Sponsor's protocol ID
- JRO-0663
- Other IDs
- IRAS ID: 357432, JRO-0663
- Acronym
- ATR-12
- Status last verified
- Sep 2026
- First submitted
- 25 Jan 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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?
- ClinicalTrials.gov ID
- NCT07391553
- Acronym / sponsor ID
- ATR-12 / JRO-0663
- Conditions
- Achilles Tendon Rupture
- Keywords
- Achilles tendon rupture, Physiotherapy, orthopaedics, trauma, rehabilitation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 115 participants (estimated)
- Lead sponsor
- Liverpool University Hospitals NHS Foundation TrustOther government
- Study start
- 8 Sep 2026 (actual)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 6 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-Surgically Managed Achilles Tendon Rupture Cohort | – | Other: Non-Surgical Management Using the SMART ProtocolAdults 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-Surgical Management Using the SMART ProtocolParticipants 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. | Other | Non-Surgically Managed Achilles Tendon Rupture Cohort |
Primary outcome
Isokinetic plantarflexor strength - Peak Torque
Time frame: 12-15 months post-injury (single study visit)
Peak plantarflexion torque will be measured using isokinetic dynamometry. Peak torque (Newton metres [Nm]) represents the maximum force generated by the plantarflexor muscles during a maximal voluntary contraction. Unit of Measure: Newton metres (Nm) Minimum value: 0 Nm Maximum value: No fixed maximum value Higher values indicate: Greater plantarflexor muscle strength (better outcome)
Isokinetic Plantarflexion Strength Normalised to Body Weight
Time frame: 12-15 months post injury
Peak plantarflexion torque normalised to body weight, measured using isokinetic dynamometry. Results are expressed as Newton metres per kilogram (Nm/kg) to facilitate comparison of plantarflexor muscle strength between individuals of different body sizes. Unit of Measure: Newton metres per kilogram (Nm/kg) Minimum Value: 0 Nm/kg Maximum Value: No fixed maximum value Higher values indicate: Greater plantarflexor muscle strength relative to body weight (better outcome)
Isokinetic Plantarflexion Strength Limb Symmetry Index (LSI)
Time frame: 12-15 months post injury
Limb Symmetry Index (LSI) for isokinetic plantarflexion strength. LSI is calculated as the peak torque of the injured limb divided by the peak torque of the uninjured limb and expressed as a percentage. An LSI of 100% indicates equal strength between limbs, while values below 100% indicate a strength deficit in the injured limb. Unit of Measure: Percent (%) Minimum Value: 0% Maximum Value: No fixed maximum value Higher values indicate: Greater symmetry between injured and uninjured limbs and therefore a better outcome.
Achilles Tendon Total Rupture Score
Time frame: 12-15 months post-injury (single study visit)
The Achilles Tendon Total Rupture Score (ATRS) is a validated patient-reported outcome measure assessing symptoms, physical activity, and functional limitations following Achilles tendon rupture. Scores range from 0 to 100, with higher scores indicating better perceived recovery and fewer symptoms. Time Frame: 12-15 months post-injury (single study visit) Unit of Measure: Points Minimum Value: 0 Maximum Value: 100 Higher scores indicate: Better outcome (fewer symptoms and greater function) Lower scores indicate: Worse outcome (more symptoms and greater functional limitation)
7 secondary outcomes
Correlation Between Achilles Tendon Total Rupture Score and Peak Plantarflexion Torque
Time frame: 12-15 months post injury
Correlation Between Achilles Tendon Total Rupture Score and Plantarflexion Strength Limb Symmetry Index
Time frame: 12-15 months post injury
Health-related quality of life - EuroQol Five-Dimension Five-Level Questionnaire (EQ-5D-5L) Summed Dimension Score
Time frame: 12-15 months post injury
Health related quality of life - EuroQol Visual Analogue Scale
Time frame: 12-15 months post injury
Achilles Tendon Resting Angle (ATRA)
Time frame: 12-15 months post injury
Return to sport/activity status
Time frame: 12-15 months post injury
Presence of Pre-Injury Achilles Tendon Symptoms
Time frame: 12-15 months post injury
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: No. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jeff Morton, BSc. (Hons) Physiotherapy study chair
Liverpool University Hospitals NHS Foundation Trust
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Achilles Tendon Rupture, run by Liverpool University Hospitals NHS Foundation Trust at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Raymond Healy, BSc. (Hons) Physiotherapy (0151 529 3335, raymond.healy@liverpoolft.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Isokinetic plantarflexor strength - Peak Torque (time frame: 12-15 months post-injury (single study visit)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.