Clinical trial NCT02308618: Rehabilitation Programs After Achilles Tendon Rupture
Official title: Achilles Tendon Rupture: Comparative Study Between Two Rehabilitation Programs.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rupture of Achilles Tendon
Immobility Response, Tonic
Rupture, Spontaneous
Keywords: Achilles tendon rupture
Rehabilitation
Immobilization
Muscle architecture
Functionality
Neuromuscular parameters
Weight-Bearing
Lead sponsor: Federal University of Rio Grande do Sul
Sponsor class: OTHER
Collaborators: name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2014-12-04
Enrollment: 47
Sex: MALE
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Torque change
timeFrame: Torque was measured 3 times during the study: three, six and more than 12 months after surgical repair.
Secondary outcomes:
measure: Ankle range of motion change
timeFrame: 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.
measure: Muscular architecture change
timeFrame: Muscle architecture was measured 4 times during the study: 45 days, three, six and more than 12 months after surgical repair.
measure: Plantarflexor muscle volume change
timeFrame: Plantarflexor muscle volume was assessed 4 times during the study: 45 days, three, six and more than 12 months after surgical repair.
Other outcomes:
measure: Muscular electrical activation change
timeFrame: Muscular electrical activation was measured 3 times during the study: three, six and more than 12 months after surgical repair
measure: Tendon mechanical and material properties change
timeFrame: Tendon mechanical and material properties were measured 3 times during the study: three, six and more than 12 months after surgical repair.
measure: Functional performance change
timeFrame: Functional performace was measured 3 times during the study: three, six and more than 12 months after surgical repair
Locations:
city: Porto Alegre
country: Brazil
facility: Exercise Research Laboratory, School of Physical Education, Federal University of Rio Grande do Sul
state: Rio Grande do Sul
Study officials:
affiliation: Federal University of Rio Grande do Sul
name: Marco A Vaz, PhD
role: PRINCIPAL_INVESTIGATOR
References: