A Pilot Study on Exercise After Achilles Tendon Rupture

Achilles Tendon Rupture Clinical Trial

— NEMEX-ATR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01298024
• Other study ID #: 2010/173
• Status: Completed
• Phase: Phase 2
• Start date: March 2011
• Est. completion date: April 2013

Study information

• Verified date: December 2022
• Source: Region Skane
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Achilles Tendon Rupture
• Rupture

Intervention

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.

Locations

Country	Name	City	State
Sweden	Skåne University Hospital	Lund	Skåne

Sponsors (2)

Lead Sponsor	Collaborator
Region Skane	Lund University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Week 16
Secondary	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.	At weeks 4, 8 and 16
Secondary	30-meters walk test	The patients walks a distance of 30 m at self-selected speed. Time and any limbing is recorded.	At weeks 8 and 16
Secondary	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.	At week 16
Secondary	VAS Pain	The patients reports pain on a 0-10 visual analog scale.	At weeks 1, 4, 8 and 16
Secondary	Range of Motion	The range of plantar and dorsal flexion motions in the talocrural joint are measured with a handheld goniometer.	At weeks 1, 4, 8 and 16
Secondary	The calf muscle circumference	Calf muscle circumference is recording using a measuring-tape.	At weeks 1, 4, 8 and 16
Secondary	Foot and Ankle Outcome Score (FAOS)	A disease specific questionnaire for patients with foot and ankle injury.	At weeks 1, 4, 8 and 16
Secondary	Short-Form 36 (SF-36)	A generic measure of health status.	At weeks 1, 4, 8 and 16
Secondary	Physical Activity Level Scale	A scale that measures the patient's level of daily physical activity.	At weeks 1, 4, 8 and 16
Secondary	Re-rupture	Joint specific adverse event; recorded by any patient seeking medical care related to the achilles tendon rupture during the study period.	Weeks 1-16
Secondary	Deep Venous thromboembolism	Joint specific adverse event; recorded by any patient seeking medical care related to the achilles tendon rupture during the study period.	Weeks 1-16
Secondary	Sick leave	The number of weeks the patient are not at work caused of the achilles tendon rupture is registered.	Measured regularly from baseline until week 16
Secondary	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.	week 16