Impact of Achilles Tendon Rupture on the Achilles Tendon and Calf Muscles

Achilles Tendon Rupture Clinical Trial

— ARCH  

Official title:

The Impact of Achilles Tendon Rupture on the Structure and Function of the Achilles Tendon and Plantarflexors: a Longitudinal Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05683080
• Other study ID #: 0881
• Status: Recruiting
• Start date: May 24, 2023
• Est. completion date: August 1, 2025

Study information

• Verified date: July 2023
• Source: University of Leicester
• Contact: Samuel Briggs-Price
• Phone: 01162525141
• Email: sbp18[@]leicester.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 1, 2025
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Achilles Tendon Rupture
• Rupture

Intervention

Other:
• Routine Clinical Care
Participants completing the research study will receive routine clinical care

Locations

Country	Name	City	State
United Kingdom	University Hosptial of Leicester NHS Trust	Leicester

Sponsors (2)

Lead Sponsor	Collaborator
University of Leicester	University Hospitals, Leicester

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Ultrasound Tissue Characterisation	Imaging of the Achilles Tendon	Week 0, week 8, week 10, 4 months, 6 months and 12 months
Secondary	Change in Achilles Tendon Rupture Score	Scores are between 0-100 with a higher score indicating less severe limitations	Week 0, week 8, week 10, 4 months, 6 months and 12 months
Secondary	Change in Hospital Anxiety and Depression Scale	The two domains (anxiety and depression) provide scores between 0-21 with a higher score indicating higher severity	Week 0, week 8, week 10, 4 months, 6 months and 12 months
Secondary	Change in EuroQol- 5 Dimension -5 Level (EQ5D)	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	Week 0, week 8, week 10, 4 months, 6 months and 12 months
Secondary	Change in International Physical Activity Questionnaire	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	Week 0, week 8, week 10, 4 months, 6 months and 12 months
Secondary	Change in Tampa Scale for Kinesiophobia	The total score of the scale range from 17- 68, where 17 means no kinesiophobia, 68 means severe kinesiophobia	Week 0, week 8, week 10, 4 months, 6 months and 12 months
Secondary	Change in Pain Catastrophising Scale	A total score is calculated from 0-54 with a higher score indicating higher pain catastrophising	Week 0, week 8, week 10, 4 months, 6 months and 12 months
Secondary	Change in Isometric plantarflexor strength testing	Isometric plantarflexor strength will be tested in plantargrade (neutral position) using the fysiometer.	Week 0, week 8, week 10, 4 months, 6 months and 12 months
Secondary	Change in Heel Raise Test	The heel raise test will measure the amount of heel raises and the work completed by the participant in joules.	Week 0, week8, week 10, 4 months, 6 months and 12 months
Secondary	Change in 36-Item Short Form Survey (SF-36)	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	Week 0, week8, week 10, 4 months, 6 months and 12 months
Secondary	Change in Activity Level	GENEactiv wrist based accelerometer measuring total steps, activity intensity 24 hours data capture for 7 days	Week 0, week8, week 10, 4 months, 6 months and 12 months
Secondary	Change in Sleep Duration	GENEactiv wrist based accelerometer measuring sleep duration for 7 days	Week 0, week8, week 10, 4 months, 6 months and 12 months