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

Primary Purpose

Achilles Tendon Rupture

Status
Completed
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
Early Neuromuscular Exercise
Sponsored by
Region Skane
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Achilles Tendon Rupture focused on measuring Achilles tendon rupture, Non-surgical treatment, Exercise, Neuromuscular training

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Skåne University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Early neuromusclar exercise

Treatment as usual (late training)

Arm Description

Outcomes

Primary Outcome Measures

Heel-raise
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 Outcome Measures

Single limb standing balance
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
The patients walks a distance of 30 m at self-selected speed. Time and any limbing is recorded.
Single-limb mini squat
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
The patients reports pain on a 0-10 visual analog scale.
Range of Motion
The range of plantar and dorsal flexion motions in the talocrural joint are measured with a handheld goniometer.
The calf muscle circumference
Calf muscle circumference is recording using a measuring-tape.
Foot and Ankle Outcome Score (FAOS)
A disease specific questionnaire for patients with foot and ankle injury.
Short-Form 36 (SF-36)
A generic measure of health status.
Physical Activity Level Scale
A scale that measures the patient's level of daily physical activity.
Re-rupture
Joint specific adverse event; recorded by any patient seeking medical care related to the achilles tendon rupture during the study period.
Deep Venous thromboembolism
Joint specific adverse event; recorded by any patient seeking medical care related to the achilles tendon rupture during the study period.
Sick leave
The number of weeks the patient are not at work caused of the achilles tendon rupture is registered.
Modified Forward lunge from stairs
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.

Full Information

First Posted
February 9, 2011
Last Updated
December 22, 2022
Sponsor
Region Skane
Collaborators
Lund University
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1. Study Identification

Unique Protocol Identification Number
NCT01298024
Brief Title
A Pilot Study on Exercise After Achilles Tendon Rupture
Acronym
NEMEX-ATR
Official Title
NEMEX-ATR: A Randomized Pilot Study on Early Neuromuscular Exercise in Non-surgically Treated Achilles Tendon Rupture
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Region Skane
Collaborators
Lund University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Achilles Tendon Rupture
Keywords
Achilles tendon rupture, Non-surgical treatment, Exercise, Neuromuscular training

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Early neuromusclar exercise
Arm Type
Experimental
Arm Title
Treatment as usual (late training)
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Early Neuromuscular Exercise
Other Intervention Name(s)
Treatment as usual (late exercise)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Heel-raise
Description
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.
Time Frame
Week 16
Secondary Outcome Measure Information:
Title
Single limb standing balance
Description
The patients stands on one leg with eyes open as long as possible, maximum time 60 seconds. Both legs are tested.
Time Frame
At weeks 4, 8 and 16
Title
30-meters walk test
Description
The patients walks a distance of 30 m at self-selected speed. Time and any limbing is recorded.
Time Frame
At weeks 8 and 16
Title
Single-limb mini squat
Description
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.
Time Frame
At week 16
Title
VAS Pain
Description
The patients reports pain on a 0-10 visual analog scale.
Time Frame
At weeks 1, 4, 8 and 16
Title
Range of Motion
Description
The range of plantar and dorsal flexion motions in the talocrural joint are measured with a handheld goniometer.
Time Frame
At weeks 1, 4, 8 and 16
Title
The calf muscle circumference
Description
Calf muscle circumference is recording using a measuring-tape.
Time Frame
At weeks 1, 4, 8 and 16
Title
Foot and Ankle Outcome Score (FAOS)
Description
A disease specific questionnaire for patients with foot and ankle injury.
Time Frame
At weeks 1, 4, 8 and 16
Title
Short-Form 36 (SF-36)
Description
A generic measure of health status.
Time Frame
At weeks 1, 4, 8 and 16
Title
Physical Activity Level Scale
Description
A scale that measures the patient's level of daily physical activity.
Time Frame
At weeks 1, 4, 8 and 16
Title
Re-rupture
Description
Joint specific adverse event; recorded by any patient seeking medical care related to the achilles tendon rupture during the study period.
Time Frame
Weeks 1-16
Title
Deep Venous thromboembolism
Description
Joint specific adverse event; recorded by any patient seeking medical care related to the achilles tendon rupture during the study period.
Time Frame
Weeks 1-16
Title
Sick leave
Description
The number of weeks the patient are not at work caused of the achilles tendon rupture is registered.
Time Frame
Measured regularly from baseline until week 16
Title
Modified Forward lunge from stairs
Description
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.
Time Frame
week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eva Ageberg, PT, PhD
Organizational Affiliation
Lund University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sylvia Resch, MD, PhD
Organizational Affiliation
Skane University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Skåne University Hospital
City
Lund
State/Province
Skåne
ZIP/Postal Code
222 37
Country
Sweden

12. IPD Sharing Statement

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A Pilot Study on Exercise After Achilles Tendon Rupture

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