Achilles Tendon RupturePhase 2NEMEX-ATRNCT01298024
A Pilot Study on Exercise After Achilles Tendon Rupture
A Phase 2 study testing Early Neuromuscular Exercise in people with Achilles Tendon Rupture, run by Region Skane at 1 site in Sweden.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Achilles Tendon Rupture
- What is being tested?
- Early Neuromuscular Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSweden
- Study dates
- Mar 2011to Apr 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Previous achilles tendon rupture
- Acute achilles tendon rupture, more than 5 days.
- Medical restrictions regarding physical exercise, not related to the achilles tendon rupture
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Conditions
- Achilles Tendon Rupture
- Being tested
- Early Neuromuscular Exercise
- Keywords
- Achilles tendon rupture, Non-surgical treatment, Exercise, Neuromuscular training
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Neuromuscular ExerciseOther
Also called Treatment as usual (late 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.
| Study group | Role | What they receive |
|---|---|---|
| Early neuromusclar exercise | Experimental | Not described Receives: Other: Early Neuromuscular Exercise |
| Treatment as usual (late training) | Active comparator | Not described Receives: Other: Early Neuromuscular Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 16
Secondary outcomes (13)
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.
Measured: At weeks 4, 8 and 16
30-meters walk test
The patients walks a distance of 30 m at self-selected speed. Time and any limbing is recorded.
Measured: At weeks 8 and 16
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.
Measured: At week 16
VAS Pain
The patients reports pain on a 0-10 visual analog scale.
Measured: At weeks 1, 4, 8 and 16
Range of Motion
The range of plantar and dorsal flexion motions in the talocrural joint are measured with a handheld goniometer.
Measured: At weeks 1, 4, 8 and 16
The calf muscle circumference
Calf muscle circumference is recording using a measuring-tape.
Measured: At weeks 1, 4, 8 and 16
Foot and Ankle Outcome Score (FAOS)
A disease specific questionnaire for patients with foot and ankle injury.
Measured: At weeks 1, 4, 8 and 16
Short-Form 36 (SF-36)
A generic measure of health status.
Measured: At weeks 1, 4, 8 and 16
Physical Activity Level Scale
A scale that measures the patient's level of daily physical activity.
Measured: At weeks 1, 4, 8 and 16
Re-rupture
Joint specific adverse event; recorded by any patient seeking medical care related to the achilles tendon rupture during the study period.
Measured: Weeks 1-16
Deep Venous thromboembolism
Joint specific adverse event; recorded by any patient seeking medical care related to the achilles tendon rupture during the study period.
Measured: Weeks 1-16
Sick leave
The number of weeks the patient are not at work caused of the achilles tendon rupture is registered.
Measured: Measured regularly from baseline until week 16
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.
Measured: week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2011 (estimated)
- Study startMar 2011
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Achilles Tendon RuptureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Collaborators
- Lund University
- Responsible party
- Sponsor
- Investigators
- Eva Ageberg, PT, PhD, Study director, Lund UniversitySylvia Resch, MD, PhD, Study director, Skane University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01298024
- Sponsor's protocol ID
- 2010/173
- Acronym
- NEMEX-ATR
- Status last verified
- Dec 2022
- First submitted
- 9 Feb 2011
- Last updated
- 23 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NEMEX-ATR: A Randomized Pilot Study on Early Neuromuscular Exercise in Non-surgically Treated Achilles Tendon Rupture
- ClinicalTrials.gov ID
- NCT01298024
- Acronym / sponsor ID
- NEMEX-ATR / 2010/173
- Conditions
- Achilles Tendon Rupture
- Keywords
- Achilles tendon rupture, Non-surgical treatment, Exercise, Neuromuscular training
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Collaborators
- Lund University
- Study start
- Mar 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 17 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early neuromusclar exercise | Experimental | Other: Early Neuromuscular Exercise |
| Treatment as usual (late training) | Active comparator | Other: Early Neuromuscular Exercise |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Previous achilles tendon rupture
- Acute achilles tendon rupture, more than 5 days.
- Medical restrictions regarding physical exercise, not related to the achilles tendon rupture
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early Neuromuscular ExerciseAlso: Treatment as usual (late 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 | Early neuromusclar exercise, Treatment as usual (late training) |
Primary outcome
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.
13 secondary outcomes
Single limb standing balance
Time frame: At weeks 4, 8 and 16
30-meters walk test
Time frame: At weeks 8 and 16
Single-limb mini squat
Time frame: At week 16
VAS Pain
Time frame: At weeks 1, 4, 8 and 16
Range of Motion
Time frame: At weeks 1, 4, 8 and 16
The calf muscle circumference
Time frame: At weeks 1, 4, 8 and 16
Foot and Ankle Outcome Score (FAOS)
Time frame: At weeks 1, 4, 8 and 16
Short-Form 36 (SF-36)
Time frame: At weeks 1, 4, 8 and 16
Physical Activity Level Scale
Time frame: At weeks 1, 4, 8 and 16
Re-rupture
Time frame: Weeks 1-16
Deep Venous thromboembolism
Time frame: Weeks 1-16
Sick leave
Time frame: Measured regularly from baseline until week 16
Modified Forward lunge from stairs
Time frame: week 16
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eva Ageberg, PT, PhD study director
Lund University
Sylvia Resch, MD, PhD study director
Skane University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Early Neuromuscular Exercise in people with Achilles Tendon Rupture, run by Region Skane at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heel-raise (time frame: Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2022.