The Achilles Tendon Length Measure (ATLM) - Development and Validation
|ClinicalTrials.gov Identifier: NCT02044016|
Recruitment Status : Completed
First Posted : January 23, 2014
Last Update Posted : August 4, 2015
|Condition or disease|
|Achilles Tendon Rupture.|
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 Type :||Observational|
|Actual Enrollment :||28 participants|
|Official Title:||The Achilles Tendon Length Measure (ATLM) - Development and Validation|
|Study Start Date :||April 2014|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||July 2015|
To compare results of the ATLM with goniometry and Ultrasound measures of the achilles tendon.
- 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.
- Goniometer measurement of the angle in the ankle joint [ Time Frame: 8 weeks after injury ]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.
- Ultrasound [ Time Frame: 8 weeks after injury ]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.
- Goniometer measurement of the angle in the ankle joint [ Time Frame: 16 weeks after injury ]The same test as after 8 weeks.
- Ultrasound [ Time Frame: 16 weeks after injury ]The same test as after 8 weeks.
- Achilles Tendon Length Measure (ATLM) [ Time Frame: 16 weeks after injury ]The same test as after 8 weeks.
- Achilles tendon Total Rupture Score [ Time Frame: A couple of days after date of injury ]A patient reported validation score developed to assess symptoms and physical activity after treatment for Achilles tendon rupture.
- Heel-rise work test [ Time Frame: 16 weeks after injury. ]Endurance test where the patient stands on one leg and lifts the heel up and down until exhaustion. The number and the height of the heel-rises are counted and measured. The results are then compared to the weight of the patient and the total work is estimated. The MuscleLab ® (Ergo Test Technology, Oslo, Norway) measurement system is used.
- Heel-rise height test [ Time Frame: 16 weeks after injury ]The patient stands facing a wall. The patient is allowed to hold 3 fingers on each hand up against the wall for support. The patient is asked to first stand on the un-injured leg and rise the heel as far up as possible. The distance between the calcaneus and the floor is being measured in millimeters. The same procedure is there after performed on the injured leg.
- Physical Activity Scale (PAS) [ Time Frame: A couple of days after date of injury ]The PAS is an instrument that measures the level of physical activity among adults.
- Achilles tendon Total Rupture Score [ Time Frame: 16 weeks after injury ]The same as after 8 weeks.
- Physical Activity Scale (PAS) [ Time Frame: 16 weeks after injury ]The same as after 8 weeks.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02044016
|Department of Physiotherapy, Hvidovre University Hospital|
|Copenhagen, Hvidovre, Denmark, DK-2650|
|Principal Investigator:||Maria Svennergren||Hvidovre University Hospital Denmark, Department of Physiotherapy|