Trial record 5 of 21 for:    Open Studies | "Achilles Tendon"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Hvidovre University Hospital
Sponsor:
Information provided by (Responsible Party):
Maria Svennergren, Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT02044016
First received: January 20, 2014
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

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.


Condition
Achilles Tendon Rupture.

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Achilles Tendon Length Measure (ATLM) - Development and Validation

Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:
  • Achilles Tendon Length Measure (ATLM) [ Time Frame: 8 weeks after injury ] [ Designated as safety issue: No ]
    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:
  • Goniometer measurement of the angle in the ankle joint [ Time Frame: 8 weeks after injury ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    The same test as after 8 weeks.

  • Ultrasound [ Time Frame: 16 weeks after injury ] [ Designated as safety issue: No ]
    The same test as after 8 weeks.

  • Achilles Tendon Length Measure (ATLM) [ Time Frame: 16 weeks after injury ] [ Designated as safety issue: No ]
    The same test as after 8 weeks.


Other Outcome Measures:
  • Achilles tendon Total Rupture Score [ Time Frame: A couple of days after date of injury ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    The same as after 8 weeks.

  • Physical Activity Scale (PAS) [ Time Frame: 16 weeks after injury ] [ Designated as safety issue: No ]
    The same as after 8 weeks.


Estimated Enrollment: 50
Study Start Date: April 2014
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Observational study
To compare results of the ATLM with goniometry and Ultrasound measures of the achilles tendon.

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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02044016

Contacts
Contact: Maria Svennergren +4553604944 maria.anna.ulla.svennergren@regionh.dk

Locations
Denmark
Department of Physiotherapy, Hvidovre University Hospital Recruiting
Copenhagen, Hvidovre, Denmark, DK-2650
Sponsors and Collaborators
Hvidovre University Hospital
Investigators
Principal Investigator: Maria Svennergren Hvidovre University Hospital Denmark, Department of Physiotherapy
  More Information

No publications provided

Responsible Party: Maria Svennergren, Physiotherapist, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT02044016     History of Changes
Other Study ID Numbers: H-4-2013-FSP
Study First Received: January 20, 2014
Last Updated: April 7, 2014
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Hvidovre University Hospital:
Achilles tendon rupture, lengthening, validity, goniometer.

Additional relevant MeSH terms:
Rupture
Wounds and Injuries

ClinicalTrials.gov processed this record on August 20, 2014