Impact of Achilles Tendon Ruptures: Cross-Sectional Analysis

Sponsor
University of Leicester (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05676632
Collaborator
University Hospitals, Leicester (Other)
90
15

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Routine Clinical Care

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 Design

Study Type:
Observational
Anticipated Enrollment :
90 participants
Observational Model:
Other
Time Perspective:
Cross-Sectional
Official Title:
The Impact of Achilles Tendon Rupture on the Structure and Function of the Achilles Tendon and Plantarflexors: a Cross Sectional Analysis
Anticipated Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
May 1, 2024
Anticipated Study Completion Date :
Aug 1, 2024

Outcome Measures

Primary Outcome Measures

  1. Ultrasound Tissue Characterisation [Week 0]

    Imaging of the Achilles Tendon

  2. Ultrasound Tissue Characterisation [week 8]

    Imaging of the Achilles Tendon

  3. Ultrasound Tissue Characterisation [week 10]

    Imaging of the Achilles Tendon

  4. Ultrasound Tissue Characterisation [4 months]

    Imaging of the Achilles Tendon

  5. Ultrasound Tissue Characterisation [6 months]

    Imaging of the Achilles Tendon

  6. Ultrasound Tissue Characterisation [12 months]

    Imaging of the Achilles Tendon

Secondary Outcome Measures

  1. 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.

  2. Heel Raise Test [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) [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) [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) [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) [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) [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) [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) [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 [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 [Week 0, week 8, week 10, 4 months, 6 months and 12 months]

    GENEactiv wrist based accelerometer measuring sleep duration for 7 days

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Leicester
  • University Hospitals, Leicester

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Leicester
ClinicalTrials.gov Identifier:
NCT05676632
Other Study ID Numbers:
  • 0882
First Posted:
Jan 9, 2023
Last Update Posted:
Jan 9, 2023
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 9, 2023