Rehabilitation Programs After Achilles Tendon Rupture

December 2, 2014 updated by: Marco Aurélio Vaz, PhD, Federal University of Rio Grande do Sul

Achilles Tendon Rupture: Comparative Study Between Two Rehabilitation Programs.

The purpose of this study is to evaluate the effects of early mobilization versus traditional immobilization rehabilitation programs after surgical Achilles tendon repair on the mechanical (torque-angle and torque-velocity relationships) and electrical (neuromuscular activation) properties of the plantar- and dorsiflexor muscles, gastrocnemius medialis morphology (muscle architecture), functional performance, and the mechanical and material properties (force-elongation and stress-strain relationships) of the injured and uninjured Achilles tendon.

The hypothesis is that the early mobilization could reduce the deleterious effects of the joint immobilization and improve the tendon healing.

Study Overview

Detailed Description

Participants were allocated into one of two intervention groups (traditional immobilization or early mobilization).

Traditional immobilization group (45 days of plaster cast immobilization; after the immobilization period, subjects received instructions on how to perform a home-based exercise program)

Early mobilization (six weeks of physical therapy program; three times per week; one to two hours of exercises for regaining range of motion and muscular endurance)

Control group (subjects had no history of lower limb injury, and were matched in age and anthropometric measurements to subjects that performed physical rehabilitation and to subjects that remained immobilized.

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90690-200
        • Exercise Research Laboratory, School of Physical Education, Federal University of Rio Grande do Sul

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Male
  • Achilles tendon rupture

Exclusion Criteria:

  • arterial insufficiency
  • diabetes
  • autoimmune disease
  • patients who used systemic antibiotics or steroids or showed any other clinical contraindication to perform maximum voluntary contractions on a dynamometer.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Traditional Immobilization
45 days of plaster cast immobilization After the immobilization period, subjects received instructions on how to perform a home-based exercise program

After surgery subjects were immobilized in a plaster cast, with the ankle positioned in gravitational equinus; weight bearing was not allowed. Two weeks post-operatively, the cast was removed and the patient was immobilized with a new plaster cast, with the ankle in the same position. Four weeks post-operatively, the ankle was plastered in neutral position (i.e. with the sole of the foot perpendicular to the shank), and weight bearing was encouraged. Six weeks post-operatively, the plaster cast was removed

The home exercise program consisted of active exercises and stretches to improve ankle range of motion, and resistance and balance exercises

Other Names:
  • Plaster cast immobilization
EXPERIMENTAL: Early mobilization
Six weeks of physical therapy program
The physical therapy started two weeks after the surgery and lasted six weeks, during which a removable brace was used. Therapy sessions, three times per week in the six-week period, included one to two hours of exercises for regaining range of motion and muscular endurance.
Other Names:
  • Accelerated rehabilitation
NO_INTERVENTION: Control
Subjects had no history of lower limb injury, and were matched in age and anthropometric measurements to subjects that performed physical rehabilitation and to subjects that remained immobilized.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Torque change
Time Frame: Torque was measured 3 times during the study: three, six and more than 12 months after surgical repair.
Torque is an expression of the muscular strength and was assessed by dynamometry
Torque was measured 3 times during the study: three, six and more than 12 months after surgical repair.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscular architecture change
Time Frame: Muscle architecture was measured 4 times during the study: 45 days, three, six and more than 12 months after surgical repair.
Muscular architecture (muscle thickness, pennation angle and fascicle length) was assessed by ultrasonography
Muscle architecture was measured 4 times during the study: 45 days, three, six and more than 12 months after surgical repair.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscular electrical activation change
Time Frame: Muscular electrical activation was measured 3 times during the study: three, six and more than 12 months after surgical repair
Electrical activation was assessed by electromyography (EMG)
Muscular electrical activation was measured 3 times during the study: three, six and more than 12 months after surgical repair
Tendon mechanical and material properties change
Time Frame: Tendon mechanical and material properties were measured 3 times during the study: three, six and more than 12 months after surgical repair.
Tendon mechanical and material properties were assessed by Achilles tendon elongation (measured by ultrasound) during isometric plantar flexion ramp contraction as a function of ankle joint torque.
Tendon mechanical and material properties were measured 3 times during the study: three, six and more than 12 months after surgical repair.
Functional performance change
Time Frame: Functional performace was measured 3 times during the study: three, six and more than 12 months after surgical repair
Functional performance was assessed by functional tests (standing heel-rise, time up and go and jump tests) and AOFAS questionnaire.
Functional performace was measured 3 times during the study: three, six and more than 12 months after surgical repair

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (ACTUAL)

August 1, 2014

Study Completion (ACTUAL)

August 1, 2014

Study Registration Dates

First Submitted

December 2, 2014

First Submitted That Met QC Criteria

December 2, 2014

First Posted (ESTIMATE)

December 4, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

December 4, 2014

Last Update Submitted That Met QC Criteria

December 2, 2014

Last Verified

December 1, 2014

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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