Impact of Achilles Tendon Rupture on the Achilles Tendon and Calf Muscles (ARCH)

August 27, 2025 updated by: University of Leicester

The Impact of Achilles Tendon Rupture on the Structure and Function of the Achilles Tendon and Plantarflexors: a Longitudinal Cohort Study

The aim of this study is to measure the recovery following Achilles tendon rupture. The investigators will use an ultrasound scan to look at the Achilles tendon, they will complete calf strength tests and use questionnaires to measure how individuals are managing in everyday life. The investigators will take these measurements when participants first arrive to the Achilles tendon rupture clinic, after 8 weeks, 10 weeks, 4 months, 6 months and 1 year.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study will measure the recovery of participants following Achilles tendon rupture. Measurements will be completed following Achilles tendon rupture, after 8 weeks, 10 weeks, 4 months, 6 months and 1 year. The measurements include an ultrasound tissue characterisation scan, isometric (static) strength test and heel raise test. In addition questionnaires will be completed by participants at each time point. Questionnaires include the Achilles Tendon Rupture Score, Hospital Anxiety and Depression Scale, EQ5D (a health related quality of life measure), International Physical Activity Questionnaire, Tampa Scale for Kinesiophobia and the Pain Catastrophising Scale.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United Kingdom
    • Leicester
      • Leicester, Leicester, United Kingdom, LE1 5WW
        • University Hosptial of Leicester NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Individuals who have experienced an Achilles Tendon Rupture and attended the Achilles Tendon Rupture Clinic

Description

Inclusion Criteria:

  • Able to provide informed consent
  • 16 years of age or above

Exclusion Criteria:

  • Inability to provide informed consent due to cognitive impairment
  • Inability to provide informed consent as unable to understand sufficient English

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Achilles Tendon Rupture
Individuals who have experienced an Achilles tendon rupture and presented to the Achilles tendon rupture clinic.
Other: Routine Clinical Care
Participants completing the research study will receive routine clinical care

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Ultrasound Tissue Characterisation
Time Frame: Week 0, week 8, week 10, 4 months, 6 months and 12 months
Imaging of the Achilles Tendon
Week 0, week 8, week 10, 4 months, 6 months and 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Achilles Tendon Rupture Score
Time Frame: Week 0, week 8, week 10, 4 months, 6 months and 12 months
Scores are between 0-100 with a higher score indicating less severe limitations
Week 0, week 8, week 10, 4 months, 6 months and 12 months
Change in Hospital Anxiety and Depression Scale
Time Frame: Week 0, week 8, week 10, 4 months, 6 months and 12 months
The two domains (anxiety and depression) provide scores between 0-21 with a higher score indicating higher severity
Week 0, week 8, week 10, 4 months, 6 months and 12 months
Change in EuroQol- 5 Dimension -5 Level (EQ5D)
Time Frame: Week 0, week 8, week 10, 4 months, 6 months and 12 months
An index score is produced which is calculated using the UK index score reference. The thermometer score is between 0-100 with a higher score indicating better perceived health
Week 0, week 8, week 10, 4 months, 6 months and 12 months
Change in International Physical Activity Questionnaire
Time Frame: Week 0, week 8, week 10, 4 months, 6 months and 12 months
Results can be reported in categories (low activity levels, moderate activity levels or high activity levels) or MET minutes representing the amount of energy expended carrying out physical activity. Higher METs indicate higher levels of physical activity
Week 0, week 8, week 10, 4 months, 6 months and 12 months
Change in Tampa Scale for Kinesiophobia
Time Frame: Week 0, week 8, week 10, 4 months, 6 months and 12 months
The total score of the scale range from 17- 68, where 17 means no kinesiophobia, 68 means severe kinesiophobia
Week 0, week 8, week 10, 4 months, 6 months and 12 months
Change in Pain Catastrophising Scale
Time Frame: Week 0, week 8, week 10, 4 months, 6 months and 12 months
A total score is calculated from 0-54 with a higher score indicating higher pain catastrophising
Week 0, week 8, week 10, 4 months, 6 months and 12 months
Change in Isometric plantarflexor strength testing
Time Frame: Week 0, week 8, week 10, 4 months, 6 months and 12 months
Isometric plantarflexor strength will be tested in plantargrade (neutral position) using the fysiometer.
Week 0, week 8, week 10, 4 months, 6 months and 12 months
Change in Heel Raise Test
Time Frame: Week 0, week8, week 10, 4 months, 6 months and 12 months
The heel raise test will measure the amount of heel raises and the work completed by the participant in joules.
Week 0, week8, week 10, 4 months, 6 months and 12 months
Change in 36-Item Short Form Survey (SF-36)
Time Frame: Week 0, week8, week 10, 4 months, 6 months and 12 months
SF-36 measures eight domains of health status: physical functioning (10 items); physical role limitations (four items); bodily pain (two items); general health perceptions (five items); energy/vitality (four items); social functioning (two items); emotional role limitations (three items) and mental health (five items). Higher scores indicate higher quality of life
Week 0, week8, week 10, 4 months, 6 months and 12 months
Change in Activity Level
Time Frame: Week 0, week8, week 10, 4 months, 6 months and 12 months
GENEactiv wrist based accelerometer measuring total steps, activity intensity 24 hours data capture for 7 days
Week 0, week8, week 10, 4 months, 6 months and 12 months
Change in Sleep Duration
Time Frame: Week 0, week8, week 10, 4 months, 6 months and 12 months
GENEactiv wrist based accelerometer measuring sleep duration for 7 days
Week 0, week8, week 10, 4 months, 6 months and 12 months
Achilles Tendon Resting Angle
Time Frame: 12 month
Measuring the resting angle of the achilles tendon
12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Leicester

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University Hospitals, Leicester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 24, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 10, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 12, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 4, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 0881

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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