Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06602908

Functional Status for Surgically and Non-surgically Treated Patients With Acute Achilles Tendon Rupture Following a Public Municipal Rehabilitation

A total Achilles tendon rupture is a common injury most often occuring in people aged between 30 and 50 years. The injury is more common amongst men than women (ratio 3:1) and typically occur during sports activities involving excentric and/or plyometric muscle work in plantar flexion of the foot (e.g., jumping, sprinting, change of directions).

Overall, there is no significant difference in treatment outcomes between surgical and non-surgical treatment besides a slightly greater risk of adverse events in surgical treatment and a small increased risk of re-rupture in non-surgical treatment. Several studies have investigated the importance of rehabilitation protocols without outcome differences between groups comparing more or less aggressive strategies.

Achilles tendon rupture often leads to significant limitations in functional level. Some of the most common used outcome measures for functional status are the heel rise tests evaluating endurance and maximum heel rise height. Studies using these tests often shows substantial deficits several years after the injury.

The purpose of this study is to investigate factors associated with functional status after rehabilitation.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre of rehabilitation Nørrebro, Copenhagen, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient has an acute achilles tendon rupture (treated within 14 days after injury).
  • Adult patients aged of 18 years or older.
  • Patients has given informed consent to participate in the study.

Exclusion criteria

  • Patients with bilateral achilles tendon rupture
  • Patients with re-rupture of previous achilles tendon rupture

Treatment and study plan

Primary outcomes

  1. Functional test battery: Heel rise test for endurance and maximal height

    Time frame: LSI is measured at the final visit during rehabilitation (Often 6 months from injury or operation). Further assessment 12 months follow up from injury or operation.

    Heel rise test for endurance:

    One legged heel rise test performed in standing position barefooted on the floor with fingertips placed against the wall for balance.

    Number of repetitions until failure is counted on non-injured leg and afterwards on injured leg. The difference between injured leg and non-injured leg is measured by

    Limb Symmetry Index in % (LSI):

    (injured leg)/(non-injured leg) x 100

    Heel rise test for maximal height:

    One legged heel rise test performed in standing position barefooted on the floor with fingertips placed against the wall for balance.

    The patient is instructed to go as high as possible. The height from the floor until the distal end of calcaneus is measured with a tape measure to the nearest 0.1 cm.

    The difference between injured leg and healthy leg is measured by

    Limb Symmetry Index in % (LSI):

    (injured leg)/(non-injured leg) x 100

Secondary outcomes

  1. Patient Specific Functional Score (PSFS)

    Time frame: Change from baseline to the final visit of rehabilitation (Often 6 months from injury or operation). Further assessment 12 months follow up from injury or operation.

    Patients are asked to identify 5 activities they are having difficulty with as a result of their current problem.

    Each activity is scored on a 0 (unable to perform activity) to 10 (able to perform activity at same level as before injury or problem) points numeric rating scale.

    An average Patient-Specific Functional Scale (PSFS) score is calculated and can vary from 0 to 10, with higher scores representing higher levels of lower extremity functional status.

  2. Pain Numeric Rating Scale (NRS)

    Time frame: Change from baseline to the final visit of rehabilitation (Often 6 months from injury or operation).

    The NRS is a modified version of the Visuel Analog Scale that consists of a segmented numerical scale with 11 points ranging from 0 to 10. The 11-point numeric scale ranges from 0 representing "no pain" to 10 representing the other pain extreme: "pain as bad as you can imagine" or "worst pain imaginable".

    This scale can be administered verbally or graphically.

  3. Achilles tendon Total Rupture Score (ATRS)

    Time frame: Change from baseline to the final visit of rehabilitation (Often 6 months from injury or operation). Further assessment 12 months follow up from injury or operation.

    The Achilles tendon Total Rupture Score (ATRS) is a commonly used patient-reported outcome measure for patients with an acute Achilles tendon rupture.

    It consists of 10 questions concerning symptoms and physical activity, for which patients are asked to respond using an 11-point Likert scale (0-10). A patient scoring 0 implies major limitations/symptoms and 10 no limitations or symptoms. Answers from all 10 questions are added to a total score, with 100 being the maximum score

  4. Thompsons test

    Time frame: Assessment at baseline and the final visit of rehabilitation (Often 6 months from injury or operation).

    Thompsons test (also called Simmonds squeeze test or Simmonds-Thompson test) is used in lower limb examination to test for the rupture of the Achilles tendon. The patient lies face down with feet hanging off the edge of the bed. If the test is positive, there is no movement of the foot (normally plantarflexion) on squeezing the corresponding calf, signifying likely rupture of the Achilles tendon.

  5. Achilles Tendon Resting Angle test (ATRA)

    Time frame: Assessment of relative ATRA (difference between non-injured and injured leg) at baseline and the final visit of rehabilitation (Often 6 months from injury or operation). Further assessment 12 months follow up from injury or operation.

    Achilles tendon resting angle (ATRA) has been suggested and used as a surrogate measure of tendon length.

    In this test, patients are positioned in prone with the knee flexed to 90 degrees, and the passive angle that the foot falls is measured using a goniometer.

    The ATRA is the angle between the long axis of the fibula and the line from the tip of the fibula to the head of the fifth metatarsal.

    Amount of tendon elongation is defined as the difference between injured and non-injured sides (positive values indicating greater tendon length on the injured side).

  6. Circumference of lower leg

    Time frame: Change from baseline to the final visit of rehabilitation (Often 6 months from injury or operation).

    Calf muscle atrophy is assessed by measuring the circumference 13 cm. below the distal apex of the patellae with a tape measure. The circumference will be recorded to the nearest 0.1 cm. and measured on both injured and the non-injured leg.

  7. The Danish 13-item Tampa Score for Kinesiophobia (TSK-13)

    Time frame: Assessment at baseline and the final visit of rehabilitation (Often 6 months from injury or operation).

    The TSK is originally a 17-item self-report scale with a 4-point response scale ranging from "strongly disagree" to "strongly agree".

    Items 4, 8, 12, and 16 are reversed for scoring. A 13-item version of the scale (TSK-13) without the four reversed items has also been widely used.

    The original 17-item scale results in a total score ranging from 17 to 68 points with increasing values indicating a stronger degree of Kinesiophobia. Therefore the 13-item version results in a total score ranging from 13 to 52 points with increasing values indicating a stronger degree of Kinesiophobia.

  8. Tegner score

    Time frame: Change from baseline to the final visit of rehabilitation (Often 6 months from injury or operation). Further assessment 12 months follow up from injury or operation.

    The Tegner activity score is developed as a measure of activity level. The rating system scores a person's activity level between 0 and 10, where 0 is "sick leave or disability pension because of the specific problem" and 10 is "participation in competitive sports such as soccer at a national or international elite level."

Other outcomes

  1. Variables that may influence on outcome: Gender

    Time frame: Assessment at baseline

    Assessed as female or male through the health record system

  2. Variables that may influence on outcome: Age

    Time frame: Assessment at baseline

    Assessed in years through the health record system

  3. Variables that may influence on outcome: Smoking status

    Time frame: Assessed at baseline

    Smoking status is described as smoking status regarding tobacco. The status is filled in by the participants with some of the patient reported outcome meassures.

    The smoking status is assessed as either smoker or non-smoker.

  4. Variables that may influence on outcome: Body Mass Index (BMI)

    Time frame: Assessment at baseline

    Body weight and height are filled in by the participants with some of the patient reported outcome meassures.

    BMI is then calculated:

    Body weight in kilograms divided by the square og the height in meters.

  5. Variables that may influence on outcome: Treatment status

    Time frame: Assessment after the final visit of rehabilitation (Often 6 months from injury or operation).

    Treatment status is described in either surgery or non-surgery. Assessed in through the health record system.

  6. Variables that may influenc on outcome: Length of rehabilitation period.

    Time frame: Assessment after the final visit of rehabilitation (Often 6 months from injury or operation).

    Length of rehabilitation period is described in number of days through the health record system.

  7. Variables that may influence on outcome: Number of supervised treatments in rehabilitation

    Time frame: Assessment after the final visit of rehabilitation (Often 6 months from injury or operation).

    Number of supervised treatments in rehabilitation is described in number of visits through the health record system.

Sponsors and collaborators

Lead sponsor

Københavns Kommune

Other

Collaborators

  • University of Southern Denmark

Registry information

Official study title

Functional Status for Surgically and Non-surgically Treated Patients With Acute Achilles Tendon Rupture Following a Public Municipal Rehabilitation - A Prospective Cohort Study

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 19, 2024
Registry last updated
Jul 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.