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Impact of Achilles Tendon Rupture on the Achilles Tendon and Calf Muscles

NCT05683080 — Completed, 60 participants, University of Leicester

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

RegistryNCT05683080, acronym ARCH
StatusCompleted
Study typeObservational
Enrollment60 (Actual)
SponsorUniversity of Leicester (Other); collaborators: University Hospitals, Leicester
ConditionsAchilles Tendon Rupture
InterventionsRoutine Clinical Care (Other)
Datesstart 2023-05-24, primary completion 2025-05-01, completion 2025-08-01, first posted 2023-01-12, last updated 2026-10-20
Locations1 site in United Kingdom

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-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. 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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Achilles Tendon RuptureOther: Routine Clinical CareIndividuals who have experienced an Achilles tendon rupture and presented to the Achilles tendon rupture clinic.
  • Routine Clinical Care (Other): Participants completing the research study will receive routine clinical care

+Outcome measures

Primary outcomes

  • Change in Ultrasound Tissue Characterisation [Week 0, week 8, week 10, 4 months, 6 months and 12 months]: Imaging of the Achilles Tendon

Secondary outcomes

  • Change in Achilles Tendon Rupture Score [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
  • Change in Hospital Anxiety and Depression Scale [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
  • Change in EuroQol- 5 Dimension -5 Level (EQ5D) [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
  • Change in International Physical Activity Questionnaire [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
  • Change in Tampa Scale for Kinesiophobia [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
  • Change in Pain Catastrophising Scale [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
  • Change in Isometric plantarflexor strength testing [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.
  • Change in Heel Raise Test [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.
  • Change in 36-Item Short Form Survey (SF-36) [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
  • Change in Activity Level [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
  • Change in Sleep Duration [Week 0, week8, week 10, 4 months, 6 months and 12 months]: GENEactiv wrist based accelerometer measuring sleep duration for 7 days
  • Achilles Tendon Resting Angle [12 month]: Measuring the resting angle of the achilles tendon

+Eligibility

Sex: All, ages: 16 Years to any

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

+Locations (1)

FacilityCityCountryStatus
University Hosptial of Leicester NHS TrustLeicester, LeicesterUnited Kingdom

My Notes