Clinical trial NCT05683080: Impact of Achilles Tendon Rupture on the Achilles Tendon and Calf Muscles
Official title: The Impact of Achilles Tendon Rupture on the Structure and Function of the Achilles Tendon and Plantarflexors: a Longitudinal Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Achilles Tendon Rupture
Lead sponsor: University of Leicester
Sponsor class: OTHER
Collaborators: name: University Hospitals, Leicester
First posted: 2023-01-12
Enrollment: 60
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals who have experienced an Achilles Tendon Rupture and attended the Achilles Tendon Rupture Clinic

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.

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: Change in Ultrasound Tissue Characterisation
timeFrame: Week 0, week 8, week 10, 4 months, 6 months and 12 months
Secondary outcomes:
measure: Change in Achilles Tendon Rupture Score
timeFrame: Week 0, week 8, week 10, 4 months, 6 months and 12 months
measure: Change in Hospital Anxiety and Depression Scale
timeFrame: Week 0, week 8, week 10, 4 months, 6 months and 12 months
measure: Change in EuroQol- 5 Dimension -5 Level (EQ5D)
timeFrame: Week 0, week 8, week 10, 4 months, 6 months and 12 months
measure: Change in International Physical Activity Questionnaire
timeFrame: Week 0, week 8, week 10, 4 months, 6 months and 12 months
measure: Change in Tampa Scale for Kinesiophobia
timeFrame: Week 0, week 8, week 10, 4 months, 6 months and 12 months
measure: Change in Pain Catastrophising Scale
timeFrame: Week 0, week 8, week 10, 4 months, 6 months and 12 months
measure: Change in Isometric plantarflexor strength testing
timeFrame: Week 0, week 8, week 10, 4 months, 6 months and 12 months
measure: Change in Heel Raise Test
timeFrame: Week 0, week8, week 10, 4 months, 6 months and 12 months
measure: Change in 36-Item Short Form Survey (SF-36)
timeFrame: Week 0, week8, week 10, 4 months, 6 months and 12 months
measure: Change in Activity Level
timeFrame: Week 0, week8, week 10, 4 months, 6 months and 12 months
measure: Change in Sleep Duration
timeFrame: Week 0, week8, week 10, 4 months, 6 months and 12 months
Other outcomes:
Locations:
city: Leicester
country: United Kingdom
facility: University Hosptial of Leicester NHS Trust
Study officials:
References: