A Pilot Study on Exercise After Achilles Tendon Rupture

Region Skane30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Achilles Tendon Rupture

Interventions

Early Neuromuscular ExerciseOTHER

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

Skåne University Hospital

Lund, Skåne County, Sweden

Outcomes

Primary Outcomes

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.

Time frame: Week 16

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: At week 16

VAS Pain

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

Time frame: 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.

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

The calf muscle circumference

Calf muscle circumference is recording using a measuring-tape.

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

Foot and Ankle Outcome Score (FAOS)

Data from ClinicalTrials.gov

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