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Completed

NCT Number: NCT02308618

Rehabilitation Programs After Achilles Tendon Rupture

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.

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Key information

Conditions

Rupture of Achilles Tendon Behavior Behavior, Animal Immobility Response, Tonic Motor Activity Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Rupture, Spontaneous

Age range

30 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Exercise Research Laboratory, School of Physical Education, Federal University of Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, 90690-200, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Traditional Immobilization

Other

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

Early mobilization

Other

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

Primary outcomes

  1. Heel rise test (HRT)

    Time frame: Heel rise height was measured 3 times during the study: three, six and more than 12 months after surgical repair.

    Heel rise height is an expression of ankle plantarflexor functional performance and was assessed using the HRT.

Secondary outcomes

  1. Muscular 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

  2. Ankle range of motion change

    Time frame: Ankle range of motion was measured 5 times during the study: 15 days, 45 days, three, six and more than 12 months after surgical repair.

    Ankle range of motion was assessed by goniometry during active and passive dorsiflexion and plantar flexion.

  3. 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

  4. Plantarflexor muscle volume change

    Time frame: Plantarflexor muscle volume was assessed 4 times during the study: 45 days, three, six and more than 12 months after surgical repair.

    Plantarflexor muscle volume was estimated from calf muscle thickness and limb length using the equation proposed by Miyatani et al. 2004.

Other outcomes

  1. 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 (time up and go and jump tests) and AOFAS questionnaire.

  2. 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)

  3. 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.

Sponsors and collaborators

Lead sponsor

Federal University of Rio Grande do Sul

Other

Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico
  • Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Registry information

Official study title

Achilles Tendon Rupture: Comparative Study Between Two Rehabilitation Programs.

Important dates

Study start
2008
Primary completion
2014
Study completion
2014
First posted
Dec 4, 2014
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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