Impact of Achilles Tendon Ruptures: Cross-Sectional Analysis

Achilles Tendon Rupture Clinical Trial

Official title:

The Impact of Achilles Tendon Rupture on the Structure and Function of the Achilles Tendon and Plantarflexors: a Cross Sectional Analysis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05676632
• Other study ID #: 0882
• Status: Not yet recruiting
• Start date: May 1, 2023
• Est. completion date: August 1, 2024

Study information

• Verified date: November 2022
• Source: University of Leicester
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: August 1, 2024
• Est. primary completion date: May 1, 2024
• 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
All participants attending the Achilles Tendon Rupture clinic will receive usual clinical care

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Leicester	University Hospitals, Leicester

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ultrasound Tissue Characterisation	Imaging of the Achilles Tendon	Week 0
Primary	Ultrasound Tissue Characterisation	Imaging of the Achilles Tendon	week 8
Primary	Ultrasound Tissue Characterisation	Imaging of the Achilles Tendon	week 10
Primary	Ultrasound Tissue Characterisation	Imaging of the Achilles Tendon	4 months
Primary	Ultrasound Tissue Characterisation	Imaging of the Achilles Tendon	6 months
Primary	Ultrasound Tissue Characterisation	Imaging of the Achilles Tendon	12 months
Secondary	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	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, week 8, week 10, 4 months, 6 months and 12 months
Secondary	Achilles Tendon Rupture Score (ATRS)	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	EuroQol- 5 Dimension - 5 Level (EQ-5D-5L)	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	Tampa Scale of Kinesiophobia (TSK)	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	Hospital Anxiety and Depression Scale (HADS)	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	International Physical Activity Questionnaire - Short Form (IPAQ-SF)	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	Week 0, week 8, week 10, 4 months, 6 months and 12 months
Secondary	Pain Catastrophizing Scale (PCS)	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	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, week 8, week 10, 4 months, 6 months and 12 months
Secondary	Accelerometer	GENEactiv wrist based accelerometer measuring total steps, activity intensity. 24 hours data capture for 7 days	Week 0, week 8, week 10, 4 months, 6 months and 12 months
Secondary	Accelerometer	GENEactiv wrist based accelerometer measuring sleep duration for 7 days	Week 0, week 8, week 10, 4 months, 6 months and 12 months