Clinical trial NCT05676632: Impact of Achilles Tendon Ruptures: Cross-Sectional Analysis
Official title: The Impact of Achilles Tendon Rupture on the Structure and Function of the Achilles Tendon and Plantarflexors: a Cross Sectional Analysis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Achilles Tendon Rupture
Lead sponsor: University of Leicester
Sponsor class: OTHER
Collaborators: name: University Hospitals, Leicester
First posted: 2023-01-09
Enrollment: 90
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals attending the Achilles tendon rupture clinic following Achilles tendon rupture

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.

Eligibility criteria: 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

Primary outcomes:
measure: Ultrasound Tissue Characterisation
timeFrame: Week 0
measure: Ultrasound Tissue Characterisation
timeFrame: week 8
measure: Ultrasound Tissue Characterisation
timeFrame: week 10
measure: Ultrasound Tissue Characterisation
timeFrame: 4 months
measure: Ultrasound Tissue Characterisation
timeFrame: 6 months
measure: Ultrasound Tissue Characterisation
timeFrame: 12 months
Secondary outcomes:
measure: Isometric plantarflexor strength testing
timeFrame: Week 0, week 8, week 10, 4 months, 6 months and 12 months
measure: Heel Raise Test
timeFrame: Week 0, week 8, week 10, 4 months, 6 months and 12 months
measure: Achilles Tendon Rupture Score (ATRS)
timeFrame: Week 0, week 8, week 10, 4 months, 6 months and 12 months
measure: EuroQol- 5 Dimension - 5 Level (EQ-5D-5L)
timeFrame: Week 0, week 8, week 10, 4 months, 6 months and 12 months
measure: Tampa Scale of Kinesiophobia (TSK)
timeFrame: Week 0, week 8, week 10, 4 months, 6 months and 12 months
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Week 0, week 8, week 10, 4 months, 6 months and 12 months
measure: International Physical Activity Questionnaire - Short Form (IPAQ-SF)
timeFrame: Week 0, week 8, week 10, 4 months, 6 months and 12 months
measure: Pain Catastrophizing Scale (PCS)
timeFrame: Week 0, week 8, week 10, 4 months, 6 months and 12 months
measure: 36-Item Short Form Survey (SF-36)
timeFrame: Week 0, week 8, week 10, 4 months, 6 months and 12 months
measure: Accelerometer
timeFrame: Week 0, week 8, week 10, 4 months, 6 months and 12 months
measure: Accelerometer
timeFrame: Week 0, week 8, week 10, 4 months, 6 months and 12 months
Other outcomes:
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