Impact of Achilles Tendon Ruptures: Cross-Sectional Analysis

January 4, 2023 updated by: University of Leicester

The Impact of Achilles Tendon Rupture on the Structure and Function of the Achilles Tendon and Plantarflexors: a 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Anticipated)

90

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Individuals attending the Achilles tendon rupture clinic following Achilles tendon rupture

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Week 0, week 8, week 10, 4 months, 6 months and 12 months
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.
Week 0, week 8, week 10, 4 months, 6 months and 12 months
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
Week 0, week 8, week 10, 4 months, 6 months and 12 months
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
Week 0, week 8, week 10, 4 months, 6 months and 12 months
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
Week 0, week 8, week 10, 4 months, 6 months and 12 months
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
Week 0, week 8, week 10, 4 months, 6 months and 12 months
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
Week 0, week 8, week 10, 4 months, 6 months and 12 months
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
Week 0, week 8, week 10, 4 months, 6 months and 12 months
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
Week 0, week 8, week 10, 4 months, 6 months and 12 months
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
Week 0, week 8, week 10, 4 months, 6 months and 12 months
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
Week 0, week 8, week 10, 4 months, 6 months and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Leicester

Collaborators

University Hospitals, Leicester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2023

Primary Completion (Anticipated)

May 1, 2024

Study Completion (Anticipated)

August 1, 2024

Study Registration Dates

First Submitted

November 10, 2022

First Submitted That Met QC Criteria

January 4, 2023

First Posted (Estimate)

January 9, 2023

Study Record Updates

Last Update Posted (Estimate)

January 9, 2023

Last Update Submitted That Met QC Criteria

January 4, 2023

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0882

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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