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

NCT ID: NCT02044016

Last Updated: 2018-08-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 28 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2015-07-31

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.

Conditions

Achilles Tendon Rupture

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Observational study

To compare results of the ATLM with goniometry and Ultrasound measures of the achilles tendon.

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hvidovre University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Maria Swennergren Hansen

Physiotherapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maria Svennergren

Role: PRINCIPAL_INVESTIGATOR

Hvidovre University Hospital Denmark, Department of Physiotherapy

Locations

Department of Physiotherapy, Hvidovre University Hospital

Copenhagen, Hvidovre, Denmark

Countries

Denmark

Other Identifiers

H-4-2013-FSP

Identifier Type: -

Identifier Source: org_study_id