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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05683080
Acronym
ARCH
Enrollment
60
Registered
2023-01-12
Start date
2023-05-24
Completion date
2025-08-01
Last updated
2025-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Achilles Tendon Rupture

Brief 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.

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.

Interventions

Participants completing the research study will receive routine clinical care

Sponsors

University Hospitals, Leicester
CollaboratorOTHER
University of Leicester
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Ultrasound Tissue CharacterisationWeek 0, week 8, week 10, 4 months, 6 months and 12 monthsImaging of the Achilles Tendon

Secondary

MeasureTime frameDescription
Change in Hospital Anxiety and Depression ScaleWeek 0, week 8, week 10, 4 months, 6 months and 12 monthsThe 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 monthsAn 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 QuestionnaireWeek 0, week 8, week 10, 4 months, 6 months and 12 monthsResults 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 KinesiophobiaWeek 0, week 8, week 10, 4 months, 6 months and 12 monthsThe total score of the scale range from 17- 68, where 17 means no kinesiophobia, 68 means severe kinesiophobia
Change in Pain Catastrophising ScaleWeek 0, week 8, week 10, 4 months, 6 months and 12 monthsA total score is calculated from 0-54 with a higher score indicating higher pain catastrophising
Change in Achilles Tendon Rupture ScoreWeek 0, week 8, week 10, 4 months, 6 months and 12 monthsScores are between 0-100 with a higher score indicating less severe limitations
Change in Heel Raise TestWeek 0, week8, week 10, 4 months, 6 months and 12 monthsThe 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 monthsSF-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 LevelWeek 0, week8, week 10, 4 months, 6 months and 12 monthsGENEactiv wrist based accelerometer measuring total steps, activity intensity 24 hours data capture for 7 days
Change in Sleep DurationWeek 0, week8, week 10, 4 months, 6 months and 12 monthsGENEactiv wrist based accelerometer measuring sleep duration for 7 days
Achilles Tendon Resting Angle12 monthMeasuring the resting angle of the achilles tendon
Change in Isometric plantarflexor strength testingWeek 0, week 8, week 10, 4 months, 6 months and 12 monthsIsometric plantarflexor strength will be tested in plantargrade (neutral position) using the fysiometer.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026