Clinical trial NCT02044016: The Achilles Tendon Length Measure (ATLM) - Development and Validation
Official title: The Achilles Tendon Length Measure (ATLM) - Development and Validation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Achilles Tendon Rupture
Keywords: Achilles tendon rupture, lengthening, validity, goniometer.
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2014-01-23
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with an acute achilles tendon rupture, between week 8 and 16 after injury. The patients are participating in a rehabilitation exercise group led by a physiotherapist 2 times a week for one hour at the time. Therefore, the patients in this study will be recruited from this program, and if they accept, they will be followed through the program, during the 2 examinations.

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.

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.

Primary outcomes:
measure: Achilles Tendon Length Measure (ATLM)
timeFrame: 8 weeks after injury
Secondary outcomes:
measure: Goniometer measurement of the angle in the ankle joint
timeFrame: 8 weeks after injury
measure: Ultrasound
timeFrame: 8 weeks after injury
measure: Goniometer measurement of the angle in the ankle joint
timeFrame: 16 weeks after injury
measure: Ultrasound
timeFrame: 16 weeks after injury
measure: Achilles Tendon Length Measure (ATLM)
timeFrame: 16 weeks after injury
Other outcomes:
measure: Achilles tendon Total Rupture Score
timeFrame: A couple of days after date of injury
measure: Heel-rise work test
timeFrame: 16 weeks after injury.
measure: Heel-rise height test
timeFrame: 16 weeks after injury
measure: Physical Activity Scale (PAS)
timeFrame: A couple of days after date of injury
measure: Achilles tendon Total Rupture Score
timeFrame: 16 weeks after injury
measure: Physical Activity Scale (PAS)
timeFrame: 16 weeks after injury
Locations:
city: Copenhagen
country: Denmark
facility: Department of Physiotherapy, Hvidovre University Hospital
state: Hvidovre
Study officials:
affiliation: Hvidovre University Hospital Denmark, Department of Physiotherapy
name: Maria Svennergren
role: PRINCIPAL_INVESTIGATOR
References: