Achilles Tendon RuptureNCT02044016
The Achilles Tendon Length Measure (ATLM) - Development and Validation
An observational study of Achilles Tendon Rupture, run by Hvidovre University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Achilles Tendon Rupture
- How many people
- 28 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2014to Jul 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Physiotherapy, Hvidovre University Hospital
Copenhagen, Hvidovre, DK-2650
About this study
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.
Read the 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
- Keywords
- Achilles tendon rupture, lengthening, validity, goniometer.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Observational study | To compare results of the ATLM with goniometry and Ultrasound measures of the achilles tendon. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achilles Tendon Length Measure (ATLM)
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.
Measured: 8 weeks after injury
Secondary outcomes (5)
Goniometer measurement of the angle in the ankle joint
Position of the subject is prone with the knee on the testing side being tested flexed to 90 degrees. The patients is is being encouraged to relax as much as possible. Centre fulcrum of the goniometer over the lateral aspect of the lateral malleolus. The proximal arm of the goniometer with the lateral midline of the fibula, using the head of the fibula for reference. The distal arm of the goniometer parallel to the lateral aspect of the fifth metatarsal. The relaxed position of the ankle is being measured.
Measured: 8 weeks after injury
Ultrasound
The patient is lying on the stomach with the knees slightly bent and ankle joints in about 15-20 degrees of plantar flexion. Two points of reference is being marked with a single dot by a pencil: 1. The proximal part of calcaneus. The ultrasound-probe is being oriented in the length of the shank. The most proximal spot of calcaneus is being localised. With a needle under the probe (upon the skin), there is a spot on the skin where the shadow spots a place where corticalis on calcaneus is being forfeit in the depth. 2. The distal tip of the medial head of the gastrocnemius. The ultrasound-probe is being oriented of the length of the shank. With a needle under the probe (upon the skin) a place on the skin exists, where the shadow spots the distal peak of the medial gastrocnemius head. The distance between the marks is being measured outside the skin with a tapeline following the contour of the shank.
Measured: 8 weeks after injury
Goniometer measurement of the angle in the ankle joint
The same test as after 8 weeks.
Measured: 16 weeks after injury
Ultrasound
The same test as after 8 weeks.
Measured: 16 weeks after injury
Achilles Tendon Length Measure (ATLM)
The same test as after 8 weeks.
Measured: 16 weeks after injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2014 (estimated)
- Study startApr 2014
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Achilles Tendon RuptureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Swennergren Hansen, Hvidovre University Hospital
- Investigators
- Maria Svennergren, Principal investigator, Hvidovre University Hospital Denmark, Department of Physiotherapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02044016
- Sponsor's protocol ID
- H-4-2013-FSP
- Status last verified
- Aug 2018
- First submitted
- 20 Jan 2014
- Last updated
- 8 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Achilles Tendon Length Measure (ATLM) - Development and Validation
- ClinicalTrials.gov ID
- NCT02044016
- Acronym / sponsor ID
- H-4-2013-FSP
- Conditions
- Achilles Tendon Rupture
- Keywords
- Achilles tendon rupture, lengthening, validity, goniometer.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 23 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational study | – | –To compare results of the ATLM with goniometry and Ultrasound measures of the achilles tendon. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Achilles Tendon Length Measure (ATLM)
Time frame: 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.
5 secondary outcomes
Goniometer measurement of the angle in the ankle joint
Time frame: 8 weeks after injury
Ultrasound
Time frame: 8 weeks after injury
Goniometer measurement of the angle in the ankle joint
Time frame: 16 weeks after injury
Ultrasound
Time frame: 16 weeks after injury
Achilles Tendon Length Measure (ATLM)
Time frame: 16 weeks after injury
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Svennergren principal investigator
Hvidovre University Hospital Denmark, Department of Physiotherapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Achilles Tendon Rupture, run by Hvidovre University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Achilles Tendon Length Measure (ATLM) (time frame: 8 weeks after injury). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2018; AzTrials last refreshed its copy on 2 Nov 2026.