Rehabilitation Programs After Achilles Tendon Rupture

NCT02308618 | Completed DMC

• 1 other identifier: UFRGS - 2007882
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rupture of Achilles Tendon; Immobility Response, Tonic; Rupture, Spontaneous

Keywords

Achilles tendon rupture; Rehabilitation; Immobilization; Muscle architecture; Functionality; Neuromuscular parameters; Weight-Bearing

Outcome Measures

Primary Outcomes (1)

• Heel rise test (HRT)

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

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

Secondary Outcomes (4)

• Muscular torque change

  Torque was measured 3 times during the study: three, six and more than 12 months after surgical repair.

• Ankle range of motion change

  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.

• Muscular architecture change

  Muscle architecture was measured 4 times during the study: 45 days, three, six and more than 12 months after surgical repair.

• Plantarflexor muscle volume change

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

Other Outcomes (3)

• Functional performance change

  Functional performace was measured 3 times during the study: three, six and more than 12 months after surgical repair

• Muscular electrical activation change

  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

  Tendon mechanical and material properties were measured 3 times during the study: three, six and more than 12 months after surgical repair.

Study Arms (3)

Traditional Immobilization

EXPERIMENTAL

45 days of plaster cast immobilization After the immobilization period, subjects received instructions on how to perform a home-based exercise program

Other: Traditional Immobilization

Early mobilization

EXPERIMENTAL

Six weeks of physical therapy program

Other: Early Mobilization

Control

NO INTERVENTION

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.

Interventions

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

Also known as: Plaster cast immobilization

Traditional 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.

Also known as: Accelerated rehabilitation

Early mobilization

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male
• Achilles tendon rupture

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of Rio Grande do Sul: lead
• Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.: collaborator
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (1)

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

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

Location

MeSH Terms

Conditions

Immobility Response, Tonic; Rupture, Spontaneous

Interventions

Early Ambulation

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior; Motor Activity; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Officials

• Marco A Vaz, PhD

  Federal University of Rio Grande do Sul

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: December 2, 2014
• First Posted: December 4, 2014
• Study Start: March 1, 2008
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: February 13, 2026

Record last verified: 2024-11

Locations

BR (1)