- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02308618
Rehabilitation Programs After Achilles Tendon Rupture
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
Status
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brazil, 90690-200
- Exercise Research Laboratory, School of Physical Education, Federal University of Rio Grande do Sul
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
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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:
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EXPERIMENTAL: Early mobilization
Six weeks of physical therapy program
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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:
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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.
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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.
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Torque is an expression of the muscular strength and was assessed by dynamometry
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Torque was measured 3 times during the study: three, six and more than 12 months after surgical repair.
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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.
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Muscular architecture (muscle thickness, pennation angle and fascicle length) was assessed by ultrasonography
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Muscle architecture was measured 4 times during the study: 45 days, three, six and more than 12 months after surgical repair.
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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
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Electrical activation was assessed by electromyography (EMG)
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Muscular electrical activation was measured 3 times during the study: three, six and more than 12 months after surgical repair
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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.
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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.
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Tendon mechanical and material properties were measured 3 times during the study: three, six and more than 12 months after surgical repair.
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Functional performance change
Time Frame: Functional performace was measured 3 times during the study: three, six and more than 12 months after surgical repair
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Functional performance was assessed by functional tests (standing heel-rise, time up and go and jump tests) and AOFAS questionnaire.
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Functional performace was measured 3 times during the study: three, six and more than 12 months after surgical repair
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UFRGS - 2007882
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