NCT07391553

Brief 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 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.

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
27mo left

Started Oct 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
8 months until next milestone

Study Start

First participant enrolled

October 1, 2026

Expected
1.7 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

July 6, 2026

Status Verified

July 1, 2026

Enrollment Period

1.7 years

First QC Date

January 25, 2026

Last Update Submit

July 1, 2026

Conditions

Keywords

Achilles tendon rupturePhysiotherapyorthopaedicstraumarehabilitation

Outcome Measures

Primary Outcomes (2)

  • 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)

  • 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 (5)

  • Correlation between isokinetic strength and ATRS

    12-15 months post injury

  • Health-related quality of life

    12-15 months post injury

  • Achilles Tendon Resting Angle

    12-15 months post injury

  • Return to sport/activity status

    12-15 months post injury

  • Pre-injury Achilles symptoms

    12-15 months post injury

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:

  • 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

You may not qualify if:

  • 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

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)

October 1, 2026

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

January 1, 2029

Last Updated

July 6, 2026

Record last verified: 2026-07

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