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Completed

NCT Number: NCT05676632

Impact of Achilles Tendon Ruptures: Cross-Sectional Analysis

This project will assess the clinical outcomes of individuals completing rehabilitation for their Achilles tendon rupture at the University Hospitals of Leicester. Patients attending the Achilles tendon rupture clinic or rehabilitation classes will be asked to complete ultrasound imaging, strength testing and questionnaires. This will provide an insight into the rehabilitation outcomes of a broad range of patients at each rehabilitation timepoint.

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Key information

Conditions

Achilles Tendon Rupture

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hosptial of Leicester NHS Trust

Leicester, LE1 5WW, United Kingdom

About this study

This study will measure the recovery of participants following Achilles tendon rupture. Measurements will capture individual participants at each rehabilitation time point following Achilles tendon rupture. These time points include following rupture (week 0), 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Routine Clinical Care

Other

All participants attending the Achilles Tendon Rupture clinic will receive usual clinical care

Primary outcomes

  1. Ultrasound Tissue Characterisation

    Time frame: Week 0

    Imaging of the Achilles Tendon

  2. Ultrasound Tissue Characterisation

    Time frame: week 8

    Imaging of the Achilles Tendon

  3. Ultrasound Tissue Characterisation

    Time frame: week 10

    Imaging of the Achilles Tendon

  4. Ultrasound Tissue Characterisation

    Time frame: 4 months

    Imaging of the Achilles Tendon

  5. Ultrasound Tissue Characterisation

    Time frame: 6 months

    Imaging of the Achilles Tendon

  6. Ultrasound Tissue Characterisation

    Time frame: 12 months

    Imaging of the Achilles Tendon

Secondary outcomes

  1. 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.

  2. Heel Raise Test

    Time frame: Week 0, week 8, 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.

  3. Achilles Tendon Rupture Score (ATRS)

    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

  4. EuroQol- 5 Dimension - 5 Level (EQ-5D-5L)

    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

  5. Tampa Scale of Kinesiophobia (TSK)

    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

  6. Hospital Anxiety and Depression Scale (HADS)

    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

  7. International Physical Activity Questionnaire - Short Form (IPAQ-SF)

    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

  8. Pain Catastrophizing Scale (PCS)

    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

  9. 36-Item Short Form Survey (SF-36)

    Time frame: Week 0, week 8, 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

  10. Accelerometer

    Time frame: Week 0, week 8, 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

  11. Accelerometer

    Time frame: Week 0, week 8, week 10, 4 months, 6 months and 12 months

    GENEactiv wrist based accelerometer measuring sleep duration for 7 days

Sponsors and collaborators

Lead sponsor

University of Leicester

Other

Collaborators

  • University Hospitals, Leicester

Registry information

Official study title

The Impact of Achilles Tendon Rupture on the Structure and Function of the Achilles Tendon and Plantarflexors: a Cross Sectional Analysis

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 9, 2023
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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