NCT07391553

Brief Summary

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. The injury and associated disability have a significant impact on patient quality of life and healthcare services. Achilles tendon ruptures are increasingly common, particularly among middle-aged recreational athletes, with an incidence estimated at 18 per 100,000 person-years. The Swansea Morriston Achilles Rupture Treatment (SMART) protocol represents a structured, progressive approach to non-operative rehabilitation. It emphasizes early mobilization, protected weight-bearing, and a gradual return to sport or high-level function through targeted strength and neuromuscular training. 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 in this patient group. 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. A secondary aim of the study is to examine the relationship between isokinetic strength scores and self reported functional recovery scores using the ATRS questionnaire. Participants will attend one 60-90 minute visit to complete a short questionnaire and perform a safe, clinic-based ankle strength test using an isokinetic machine; the test feels like pushing against a footplate, similar to resisted ankle movements. The results of these tests will be collected and analysed. The study will help to gain further insight into patient recovery from this injury.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
115

participants targeted

Target at P50-P75 for all trials

Timeline
32mo left

Started Jun 2026

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 6, 2026

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2028

7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2029

Last Updated

March 3, 2026

Status Verified

February 1, 2026

Enrollment Period

2 years

First QC Date

January 25, 2026

Last Update Submit

February 27, 2026

Conditions

Keywords

Achilles tendon rupturePhysiotherapyorthopaedicstraumarehabilitation

Outcome Measures

Primary Outcomes (4)

  • Peak Plantarflexion Torque (Nm)

    Maximum rotational force produced by the plantarflexor muscles during an isokinetic concentric contraction, measured using an isokinetic dynamometer. This measure reflects calf muscle strength and tendon function following non-surgical Achilles tendon rupture management.

    12-15 months post-injury (single study visit)

  • Peak Plantarflexion Torque Normalized to Bodyweight (Nm/kg)

    Peak plantarflexion torque adjusted for each participant's bodyweight. Normalisation allows strength comparisons between individuals of different body sizes and provides a more functional evaluation of recovery.

    12-15 months post-injury (single study visit)

  • Limb Symmetry Index (LSI) for Peak Torque (%)

    Ratio of injured limb peak plantarflexion torque to the uninjured limb, expressed as a percentage. An LSI ≥90% is typically considered indicative of satisfactory recovery.

    12-15 months post-injury (single study visit)

  • 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)

Secondary Outcomes (1)

  • Correlation Between Isokinetic Strength Measures and Achilles Tendon Total Rupture Score

    12-15 months post-injury (single study visit)

Study Arms (1)

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

Interventions

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.

Non-Surgically Managed Achilles Tendon Rupture Cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Adults aged 18 years or older at the time of recruitment.
  • Confirmed diagnosis of Achilles tendon rupture, diagnosed clinically and recorded within the NHS database.
  • Injury managed non-surgically using the SMART (Swansea Morriston Achilles Rupture Treatment) protocol.
  • months post-injury at the time of assessment.
  • Able and willing to provide informed written consent to participate in the study.

You may not qualify if:

  • Unable to provide informed consent.
  • Previous surgical repair of the Achilles tendon or documented re-rupture.
  • Presence of a neuromuscular disorder affecting lower limb strength or function.
  • Did not follow the SMART protocol for non-surgical management.
  • History of Achilles tendinopathy or rupture in the contralateral (uninjured) leg.
  • Unable to tolerate isokinetic strength testing due to pain, discomfort, or other medical reasons.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Broadgreen Hospital Physiotherapy department

Liverpool, Merseyside, L14 3LB, United Kingdom

Location

Aintree University Hospital Therapies department

Liverpool, Merseyside, L9 7 AL, United Kingdom

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

  • Jeff Morton, BSc. (Hons) Physiotherapy

    Liverpool University Hospitals NHS Foundation Trust

    STUDY CHAIR

Central Study Contacts

Raymond Healy, BSc. (Hons) Physiotherapy

CONTACT

Jeff Morton, BSc. (Hons) Physiotherapy

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Physiotherapist

Study Record Dates

First Submitted

January 25, 2026

First Posted

February 6, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

January 1, 2029

Last Updated

March 3, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

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

Locations