The Achilles Tendon Length Measure (ATLM) - Development and Validation

Completed

• Conditions: Achilles Tendon Rupture

• Registration Number: NCT02044016
• Lead Sponsor: Hvidovre University Hospital

Brief Summary

The purpose of this study is 1) to develop and validate a new measurement to assess the length of the Achilles tendon after rupture, and 2) to examine if goniometer measurement of the ankle joint is a better method.

Detailed Description

It has been shown that an Achilles tendon elongation compared to the un-injured leg is negatively associated with the clinical outcome and strength of the gastrocnemius muscle. Despite this knowledge, there is a lack of a valid score system that can measure the length of the Achilles tendon in daily clinical practice. Patients, who follow a rehabilitation program at the Department of Physiotherapy, also have their Achilles tendon examined for lengthening by physiotherapists, to evaluate if the heeling progresses as planned. Of concern, this examination is based on measures, which have not been thoroughly validated.

The ATLM test use the same test position of the lower limb as being used in Matles test. Besides observing the foot's position, we will measure the distance from a point of reference on the foot to the examination coach. Reproducibility and responsiveness of the ATLM will be examined, while concurrent validity will be examined against ultrasound and a goniometry measure. The ultrasound is considered the most precise, secure and objective measure.

The ATLM and goniometer measures will be conducted at 8 and 16 weeks after the injury. At 8 weeks there will be two physiotherapists conducting these measures (to investigate inter-tester reliability). The ruler and goniometer will have the numbers hidden. A third physiotherapist will read the results at 8 and 16 weeks, so that the physiotherapists will be blinded towards the results. A person blinded to these results will conduct the ultrasound.

Study Timeline

• Study First Submitted: 2014-01-20
• Study First Submitted QC: 2014-01-21
• Study First Posted: 2014-01-23
• Study Start: 2014-04
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-07
• Last Update Posted: 2018-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• Patients aged 18-60.
• Patients who are being referred to the rehabilitation program for patients with an AATR, at Hvidovre Hospital.
• The patients have to speak and understand Danish.
• The patients have to be able to sign the written informed consent.

Exclusion Criteria

• Patients who earlier have had a rupture of one or both AT.
• Patients who have had an operation one of the achilles tendons before.
• Patients who have been diagnosed with arterial insufficiency in legs.
• Patients with a terminal disease or who suffers from a critical medical illness.
• Patients where the distance from rupture to calcaneus is less than 1 cm (examined by palpation or in doubt, measured with an ultrasound)
• Fluoroquinolone treatment within the last 6 months.
• Tendinosis treated with corticosteroids (tablets or injections) within the last 6 months.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Achilles Tendon Length Measure (ATLM)	8 weeks after injury	The tester position one leg with a knee joint ankle to 90 degrees flexion. The other hand of the tester holds the ruler op against the foot. A plate in a hard, stiff wooden material is placed underneath the patient's thighs and knees. A ruler that is 100 cm long (25x5 mm) made in wood is being used. The tester is seated at the end of the examination coach. Besides observing the foot's position, we will measure the distances from points of reference on the foot to the examination coach. Points of reference: 1) The middle (and most prominent) point of the head of the fifth metatarsophalangeal head seen from the lateral side. 2) From the middle point of the lateral malleolus down to the examination coach).Take the first measure (metatarsophalangeal head-examination coach) and subtract this with the second one (lateral malleolus-examination coach). See if there is a difference between uninjured and injured side. Here you get the ATLM.

Secondary Outcome Measures

Name	Time	Method
Goniometer measurement of the angle in the ankle joint	16 weeks after injury	The same test as after 8 weeks.
Ultrasound	16 weeks after injury	The same test as after 8 weeks.
Achilles Tendon Length Measure (ATLM)	16 weeks after injury	The same test as after 8 weeks.

Trial Locations

Locations (1)

Department of Physiotherapy, Hvidovre University Hospital; 🇩🇰 Copenhagen, Hvidovre, Denmark