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NCT Number: NCT01298024

A Pilot Study on Exercise After Achilles Tendon Rupture

The purpose is to study the effect of early NEuroMuscular EXercise (NEMEX) versus conventional treatment (late exercise) in patients with acute non-operative achilles tendon rupture (ATR).

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Key information

Conditions

Achilles Tendon Rupture Behavior Motor Activity

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Skåne University Hospital

Lund, Skåne County, 222 37, Sweden

About this study

There is currently no consensus on treatment for achilles tendon rupture with regard to surgical or non-surgical treatment. In addition, the optimal time to start exercise treatment after the injury, with or without surgery, is not well understood. Animal studies show positive effects of early mobilization in tendon healing. Neuromuscular exercise has shown better effects than strength exercise in people with knee injury or knee disease. There are few studies in humans focusing on exercise as treatment, without surgical intervention, after ATR.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Men and women 18 - 60 years.
  • The patient should before the achilles tendon rupture have been able to walk independently without aid, walk without limping, run/jog and be able to jump on one leg
  • The patient shall be able to read, understand and to assimilate the written information about the study.

Exclusion criteria

  • Previous achilles tendon rupture
  • Acute achilles tendon rupture, more than 5 days.
  • Medical restrictions regarding physical exercise, not related to the achilles tendon rupture

Treatment and study plan

Early Neuromuscular Exercise

Other

30 patients are randomized to early neuromuscular exercise (n=15) or treatment as usual, i.e., late exercise (n=15). Both groups are given an orthosis and are instructed to wear this for eight weeks. The experimental group starts with a structured exercise program one week after the diagnosis. The patients attend one training session/week during eight weeks, guided by a physical therapist. The level of training is progressed during this time. The patients in the control group (treatment as usual) are given exercise instructions and information at one occasion; 2 weeks after diagnosis. Both groups are followed up, by a blinded assessor, with valid and reliable self-reported and physical function outcomes at 1, 4, 8 and 16 weeks after injury.

Other names: Treatment as usual (late exercise)

Primary outcomes

  1. Heel-raise

    Time frame: Week 16

    Functional performance of calf muscles. The ability to perform a plantar flexion is assessed in a prone position at 1 and 4 weeks after the injury. At 8 and 16 weeks after the injury, the ability to perform a heel-raise standing on one leg is assessed.

Secondary outcomes

  1. Single limb standing balance

    Time frame: At weeks 4, 8 and 16

    The patients stands on one leg with eyes open as long as possible, maximum time 60 seconds. Both legs are tested.

  2. 30-meters walk test

    Time frame: At weeks 8 and 16

    The patients walks a distance of 30 m at self-selected speed. Time and any limbing is recorded.

  3. Single-limb mini squat

    Time frame: At week 16

    The patients performs single-limb mini squats. The position of the knee in relation to the foot is assessed. The test is performed on both legs.

  4. VAS Pain

    Time frame: At weeks 1, 4, 8 and 16

    The patients reports pain on a 0-10 visual analog scale.

  5. Range of Motion

    Time frame: At weeks 1, 4, 8 and 16

    The range of plantar and dorsal flexion motions in the talocrural joint are measured with a handheld goniometer.

  6. The calf muscle circumference

    Time frame: At weeks 1, 4, 8 and 16

    Calf muscle circumference is recording using a measuring-tape.

  7. Foot and Ankle Outcome Score (FAOS)

    Time frame: At weeks 1, 4, 8 and 16

    A disease specific questionnaire for patients with foot and ankle injury.

  8. Short-Form 36 (SF-36)

    Time frame: At weeks 1, 4, 8 and 16

    A generic measure of health status.

  9. Physical Activity Level Scale

    Time frame: At weeks 1, 4, 8 and 16

    A scale that measures the patient's level of daily physical activity.

  10. Re-rupture

    Time frame: Weeks 1-16

    Joint specific adverse event; recorded by any patient seeking medical care related to the achilles tendon rupture during the study period.

  11. Deep Venous thromboembolism

    Time frame: Weeks 1-16

    Joint specific adverse event; recorded by any patient seeking medical care related to the achilles tendon rupture during the study period.

  12. Sick leave

    Time frame: Measured regularly from baseline until week 16

    The number of weeks the patient are not at work caused of the achilles tendon rupture is registered.

  13. Modified Forward lunge from stairs

    Time frame: week 16

    The patient stands on the first step of a staircase and is encouraged to take step down with one leg, the other leg kept on the step. The examiner stands in front of the patient and observes position of joints in relation to each other.

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Collaborators

  • Lund University

Registry information

Official study title

NEMEX-ATR: A Randomized Pilot Study on Early Neuromuscular Exercise in Non-surgically Treated Achilles Tendon Rupture

Acronym: NEMEX-ATR

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Feb 17, 2011
Registry last updated
Dec 23, 2022

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.

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