Impact of Achilles Tendon Ruptures: Cross-Sectional Analysis
- Conditions
- Achilles Tendon Rupture
- Registration Number
- NCT05676632
- Lead Sponsor
- University of Leicester
- 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.
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 90
- Able to provide informed consent
- 16 years of age or above
- Inability to provide informed consent due to cognitive impairment
- Inability to provide informed consent as unable to understand sufficient English
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Ultrasound Tissue Characterisation 12 months Imaging of the Achilles Tendon
- Secondary Outcome Measures
Name Time Method 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.
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
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
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
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.
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
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
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
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
Accelerometer Week 0, week 8, week 10, 4 months, 6 months and 12 months GENEactiv wrist based accelerometer measuring sleep duration for 7 days