Impact of Achilles Tendon Rupture on the Achilles Tendon and Calf Muscles
- Conditions
- Achilles Tendon Rupture
- Interventions
- Other: Routine Clinical Care
- Registration Number
- NCT05683080
- Lead Sponsor
- University of Leicester
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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
- Arm && Interventions
Group Intervention Description Achilles Tendon Rupture Routine Clinical Care Individuals who have experienced an Achilles tendon rupture and presented to the Achilles tendon rupture clinic.
- Primary Outcome Measures
Name Time Method Change in Ultrasound Tissue Characterisation Week 0, week 8, week 10, 4 months, 6 months and 12 months Imaging of the Achilles Tendon
- Secondary Outcome Measures
Name Time Method Change in International Physical Activity Questionnaire 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 physical activity. Higher METs indicate higher levels of physical activity
Change in Sleep Duration Week 0, week8, week 10, 4 months, 6 months and 12 months GENEactiv wrist based accelerometer measuring sleep duration for 7 days
Change in Pain Catastrophising Scale 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
Change in EuroQol- 5 Dimension -5 Level (EQ5D) 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
Change in Tampa Scale for Kinesiophobia 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
Change in Heel Raise Test Week 0, week8, 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.
Change in Achilles Tendon Rupture Score 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
Change in 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.
Change in 36-Item Short Form Survey (SF-36) Week 0, week8, 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
Change in Hospital Anxiety and Depression Scale 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
Change in Activity Level Week 0, week8, 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
Trial Locations
- Locations (1)
University Hosptial of Leicester NHS Trust
🇬🇧Leicester, United Kingdom