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

NCT06602908 | Active Not Recruiting

• 1 other identifier: F-24036357
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Achilles Tendon Rupture

Keywords

Achilles Tendon Rupture; Cohort Study; Functional Status; Heel Rise Tests; Associating Factors; Public Municipal Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Functional test battery: Heel rise test for endurance and maximal height

  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

  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.

Secondary Outcomes (8)

• Patient Specific Functional Score (PSFS)

  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.

• Pain Numeric Rating Scale (NRS)

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

• Achilles tendon Total Rupture Score (ATRS)

  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.

• Thompsons test

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

• Achilles Tendon Resting Angle test (ATRA)

  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.

Other Outcomes (7)

• Variables that may influence on outcome: Gender

  Assessment at baseline

• Variables that may influence on outcome: Age

  Assessment at baseline

• Variables that may influence on outcome: Smoking status

  Assessed at baseline

Study Arms (1)

Surgically and non-surgically treated patients with achilles tendon rupture

One hundred patients with surgically and non-surgically treated achilles tendon rupture referred to rehabilitation in the municipality of Copenhagen.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Surgically and non-surgically treated achilles tendon rupture referred to rehabilitation in the municipality of Copenhagen.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Københavns Kommune: lead
• University of Southern Denmark: collaborator

Study Sites (2)

Centre of rehabilitation Nørrebro

Copenhagen, 2200, Denmark

Location

Centre of rehabilitation Vanløse

Vanløse, 2720, Denmark

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 9 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator. Cand. scient phys. University of Southern Denmark. Developmental physiotherapist, Centre of Rehabilitation Copenhagen City, Denmark

Study Record Dates

• First Submitted: September 7, 2024
• First Posted: September 19, 2024
• Study Start: September 15, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: July 29, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)