Achilles Tendon RuptureARCHNCT05683080
Impact of Achilles Tendon Rupture on the Achilles Tendon and Calf Muscles
An observational study of Achilles Tendon Rupture, run by University of Leicester at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Achilles Tendon Rupture
- What is being tested?
- Routine Clinical Care
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 May 2023to 1 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Individuals who have experienced an Achilles Tendon Rupture and attended the Achilles Tendon Rupture Clinic
Who may be able to join
- Able to provide informed consent
- 16 years of age or above
Who cannot join
- Inability to provide informed consent due to cognitive impairment
- Inability to provide informed consent as unable to understand sufficient English
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hosptial of Leicester NHS Trust
Leicester, Leicester, LE1 5WW
About this study
Official title: 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.
Read the 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.
- Conditions
- Achilles Tendon Rupture
- Being tested
- Routine Clinical Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine Clinical CareOther
Participants completing the research study will receive routine clinical care
| Study group | Role | What they receive |
|---|---|---|
| Achilles Tendon Rupture | Individuals who have experienced an Achilles tendon rupture and presented to the Achilles tendon rupture clinic. Receives: Other: Routine Clinical Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Ultrasound Tissue Characterisation
Imaging of the Achilles Tendon
Measured: Week 0, week 8, week 10, 4 months, 6 months and 12 months
Secondary outcomes (12)
Change in Achilles Tendon Rupture Score
Scores are between 0-100 with a higher score indicating less severe limitations
Measured: Week 0, week 8, week 10, 4 months, 6 months and 12 months
Change in Hospital Anxiety and Depression Scale
The two domains (anxiety and depression) provide scores between 0-21 with a higher score indicating higher severity
Measured: Week 0, week 8, week 10, 4 months, 6 months and 12 months
Change in EuroQol- 5 Dimension -5 Level (EQ5D)
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
Measured: Week 0, week 8, week 10, 4 months, 6 months and 12 months
Change in International Physical Activity Questionnaire
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
Measured: Week 0, week 8, week 10, 4 months, 6 months and 12 months
Change in Tampa Scale for Kinesiophobia
The total score of the scale range from 17- 68, where 17 means no kinesiophobia, 68 means severe kinesiophobia
Measured: Week 0, week 8, week 10, 4 months, 6 months and 12 months
Change in Pain Catastrophising Scale
A total score is calculated from 0-54 with a higher score indicating higher pain catastrophising
Measured: Week 0, week 8, week 10, 4 months, 6 months and 12 months
Change in Isometric plantarflexor strength testing
Isometric plantarflexor strength will be tested in plantargrade (neutral position) using the fysiometer.
Measured: Week 0, week 8, week 10, 4 months, 6 months and 12 months
Change in Heel Raise Test
The heel raise test will measure the amount of heel raises and the work completed by the participant in joules.
Measured: Week 0, week8, week 10, 4 months, 6 months and 12 months
Change in 36-Item Short Form Survey (SF-36)
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
Measured: Week 0, week8, week 10, 4 months, 6 months and 12 months
Change in Activity Level
GENEactiv wrist based accelerometer measuring total steps, activity intensity 24 hours data capture for 7 days
Measured: Week 0, week8, week 10, 4 months, 6 months and 12 months
Change in Sleep Duration
GENEactiv wrist based accelerometer measuring sleep duration for 7 days
Measured: Week 0, week8, week 10, 4 months, 6 months and 12 months
Achilles Tendon Resting Angle
Measuring the resting angle of the achilles tendon
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2023
- Study start24 May 2023
- Primary completion1 May 2025
- Study completion1 Aug 2025
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
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leicester
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospitals, Leicester
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05683080
- Sponsor's protocol ID
- 0881
- Acronym
- ARCH
- Status last verified
- Oct 2026
- First submitted
- 10 Nov 2022
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Achilles Tendon Rupture on the Structure and Function of the Achilles Tendon and Plantarflexors: a Longitudinal Cohort Study
- ClinicalTrials.gov ID
- NCT05683080
- Acronym / sponsor ID
- ARCH / 0881
- Conditions
- Achilles Tendon Rupture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of LeicesterUniversity, hospital or other
- Collaborators
- University Hospitals, Leicester
- Study start
- 24 May 2023 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 12 Jan 2023 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Achilles Tendon Rupture | – | Other: Routine Clinical CareIndividuals who have experienced an Achilles tendon rupture and presented to the Achilles tendon rupture clinic. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Individuals who have experienced an Achilles Tendon Rupture and attended the Achilles Tendon Rupture Clinic
Key inclusion criteria (2 listed)
- Able to provide informed consent
- 16 years of age or above
Key exclusion criteria (2 listed)
- Inability to provide informed consent due to cognitive impairment
- Inability to provide informed consent as unable to understand sufficient English
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 |
|---|---|---|
| Routine Clinical CareParticipants completing the research study will receive routine clinical care | Other | Achilles Tendon Rupture |
Primary outcome
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
12 secondary outcomes
Change in Achilles Tendon Rupture Score
Time frame: 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
Change in EuroQol- 5 Dimension -5 Level (EQ5D)
Time frame: 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
Change in Tampa Scale for Kinesiophobia
Time frame: 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
Change in Isometric plantarflexor strength testing
Time frame: 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
Change in 36-Item Short Form Survey (SF-36)
Time frame: 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
Change in Sleep Duration
Time frame: Week 0, week8, week 10, 4 months, 6 months and 12 months
Achilles Tendon Resting Angle
Time frame: 12 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 University of Leicester at 1 site 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Ultrasound Tissue Characterisation (time frame: Week 0, week 8, week 10, 4 months, 6 months and 12 months). 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 20 Oct 2026.