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A Pilot Study on Exercise After Achilles Tendon Rupture (NEMEX-ATR)

This study has been completed.
Sponsor:
Collaborator:
Lund University
Information provided by (Responsible Party):
Region Skane
ClinicalTrials.gov Identifier:
NCT01298024
First received: February 9, 2011
Last updated: April 5, 2013
Last verified: August 2012
History of Changes

February 9, 2011
April 5, 2013
March 2011
April 2013   (final data collection date for primary outcome measure)
Heel-raise [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01298024 on ClinicalTrials.gov Archive Site
  • Single limb standing balance [ Time Frame: At weeks 4, 8 and 16 ] [ Designated as safety issue: No ]
    The patients stands on one leg with eyes open as long as possible, maximum time 60 seconds. Both legs are tested.
  • 30-meters walk test [ Time Frame: At weeks 8 and 16 ] [ Designated as safety issue: No ]
    The patients walks a distance of 30 m at self-selected speed. Time and any limbing is recorded.
  • Single-limb mini squat [ Time Frame: At week 16 ] [ Designated as safety issue: No ]
    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.
  • VAS Pain [ Time Frame: At weeks 1, 4, 8 and 16 ] [ Designated as safety issue: No ]
    The patients reports pain on a 0-10 visual analog scale.
  • Range of Motion [ Time Frame: At weeks 1, 4, 8 and 16 ] [ Designated as safety issue: No ]
    The range of plantar and dorsal flexion motions in the talocrural joint are measured with a handheld goniometer.
  • The calf muscle circumference [ Time Frame: At weeks 1, 4, 8 and 16 ] [ Designated as safety issue: No ]
    Calf muscle circumference is recording using a measuring-tape.
  • Foot and Ankle Outcome Score (FAOS) [ Time Frame: At weeks 1, 4, 8 and 16 ] [ Designated as safety issue: No ]
    A disease specific questionnaire for patients with foot and ankle injury.
  • Short-Form 36 (SF-36) [ Time Frame: At weeks 1, 4, 8 and 16 ] [ Designated as safety issue: No ]
    A generic measure of health status.
  • Physical Activity Level Scale [ Time Frame: At weeks 1, 4, 8 and 16 ] [ Designated as safety issue: No ]
    A scale that measures the patient's level of daily physical activity.
  • Re-rupture [ Time Frame: Weeks 1-16 ] [ Designated as safety issue: Yes ]
    Joint specific adverse event; recorded by any patient seeking medical care related to the achilles tendon rupture during the study period.
  • Deep Venous thromboembolism [ Time Frame: Weeks 1-16 ] [ Designated as safety issue: Yes ]
    Joint specific adverse event; recorded by any patient seeking medical care related to the achilles tendon rupture during the study period.
  • Sick leave [ Time Frame: Measured regularly from baseline until week 16 ] [ Designated as safety issue: No ]
    The number of weeks the patient are not at work caused of the achilles tendon rupture is registered.
  • Modified Forward lunge from stairs [ Time Frame: week 16 ] [ Designated as safety issue: No ]
    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.
  • Single limb standing balance [ Time Frame: At weeks 4, 8 and 16 ] [ Designated as safety issue: No ]
    The patients stands on one leg with eyes open as long as possible, maximum time 60 seconds. Both legs are tested.
  • 30-meters walk test [ Time Frame: At weeks 8 and 16 ] [ Designated as safety issue: No ]
    The patients walks a distance of 30 m at self-selected speed. Time and any limbing is recorded.
  • One leg jump test [ Time Frame: At week 16 ] [ Designated as safety issue: No ]
    The jump is performed on one leg, taking off and landing on the same foot, with the hands placed behind the back. The hop distance is measured in cm.
  • Hopping [ Time Frame: At week 16 ] [ Designated as safety issue: No ]
    The patients performs 25 repeated hops on one leg with the arms at the sides. The time and jump height are measured.
  • Single-limb mini squat [ Time Frame: At week 16 ] [ Designated as safety issue: No ]
    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.
  • Calf muscle strength peak torque and endurance [ Time Frame: At week 16 ] [ Designated as safety issue: No ]
    Calf muscle strength peak torque and endurance is assessed using a dynamometer.
  • VAS Pain [ Time Frame: At weeks 1, 4, 8 and 16 ] [ Designated as safety issue: No ]
    The patients reports pain on a 0-10 visuell analog scale.
  • Range of Motion [ Time Frame: At weeks 1, 4, 8 and 16 ] [ Designated as safety issue: No ]
    The range of plantar and dorsal flexion motions in the talucural joint are measured with a handheld goniometer.
  • The calf muscle circumference [ Time Frame: At weeks 1, 4, 8 and 16 ] [ Designated as safety issue: No ]
    Calf muscle circumference is recording using a measuring-tape.
  • Foot and Ankle Outcome Score (FAOS) [ Time Frame: At weeks 1, 4, 8 and 16 ] [ Designated as safety issue: No ]
    A disease specific questionnaire for patients with foot and ankle injury.
  • SF-36 [ Time Frame: At weeks 1, 4, 8 and 16 ] [ Designated as safety issue: No ]
    A generic measure of health status.
  • Physical Activity Level Scale [ Time Frame: At weeks 1, 4, 8 and 16 ] [ Designated as safety issue: No ]
    A scale that measures the patient's level of daily physical activity.
  • Re-rupture [ Time Frame: Weeks 1-16 ] [ Designated as safety issue: Yes ]
    Joint specific adverse event; recorded by any patient seeking medical care related to the achilles tendon rupture during the study period.
  • Deep Venous thromboembolism [ Time Frame: Weeks 1-16 ] [ Designated as safety issue: Yes ]
    Joint specific adverse event; recorded by any patient seeking medical care related to the achilles tendon rupture during the study period.
  • Sick leave [ Time Frame: Measured regally from baseline until week 16 ] [ Designated as safety issue: No ]
    The number of weeks the patient are not at work caused of the achilles tendon rupture is registered.
Not Provided
Not Provided
 
A Pilot Study on Exercise After Achilles Tendon Rupture
NEMEX-ATR: A Randomized Pilot Study on Early Neuromuscular Exercise in Non-surgically Treated 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).

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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Achilles Tendon Rupture
Other: Early Neuromuscular Exercise
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 Name: Treatment as usual (late exercise)
  • Experimental: Early neuromusclar exercise
    Intervention: Other: Early Neuromuscular Exercise
  • Active Comparator: Treatment as usual (late training)
    Intervention: Other: Early Neuromuscular Exercise
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
April 2013
April 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Men and women 18 - 60 years.
  2. 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
  3. The patient shall be able to read, understand and to assimilate the written information about the study.

Exclusion Criteria:

  1. Previous achilles tendon rupture
  2. Acute achilles tendon rupture, more than 5 days.
  3. Medical restrictions regarding physical exercise, not related to the achilles tendon rupture
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01298024
2010/173
Yes
Region Skane
Region Skane
Lund University
Study Director: Eva Ageberg, PT, PhD Lund University
Study Director: Sylvia Resch, MD, PhD Skane University Hospital
Region Skane
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP