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

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: Recruiting
• Conditions: Achilles Tendon Rupture
• Intervention / Treatment: Other: Routine Clinical Care

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: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Samuel Briggs-Price; Phone Number: 01162525141; Email: sbp18@leicester.ac.uk

Study Locations

• United Kingdom
  • Leicester, United Kingdom, LE1 5WW
    • Recruiting
    • University Hosptial of Leicester NHS Trust
    • Contact: Sam Briggs
    • Principal Investigator: Seth O'Neill
    • Sub-Investigator: Sam Briggs-Price

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Change in Ultrasound Tissue Characterisation	Imaging of the Achilles Tendon	Week 0, week 8, week 10, 4 months, 6 months and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Achilles Tendon Rupture Score	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	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)	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	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	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	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	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	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)	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	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	GENEactiv wrist based accelerometer measuring sleep duration for 7 days	Week 0, week8, week 10, 4 months, 6 months and 12 months

Collaborators and Investigators

• Sponsor: University of Leicester
• Collaborators: University Hospitals, Leicester

Study record dates

Study Major Dates

• Study Start (Actual): May 24, 2023
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: November 10, 2022
• First Submitted That Met QC Criteria: January 5, 2023
• First Posted (Actual): January 12, 2023

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture
• Other Study ID 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