Rehabilitation Programs After Achilles Tendon Rupture
Primary Purpose
Rupture of Achilles Tendon, Immobility Response, Tonic, Rupture, Spontaneous
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Traditional Immobilization
Early Mobilization
Sponsored by
About this trial
This is an interventional treatment trial for Rupture of Achilles Tendon focused on measuring Achilles tendon rupture, Rehabilitation, Immobilization, Muscle architecture, Functionality, Neuromuscular parameters, Weight-Bearing
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.
Sites / Locations
- Exercise Research Laboratory, School of Physical Education, Federal University of Rio Grande do Sul
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Traditional Immobilization
Early mobilization
Control
Arm Description
45 days of plaster cast immobilization After the immobilization period, subjects received instructions on how to perform a home-based exercise program
Six weeks of physical therapy program
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.
Outcomes
Primary Outcome Measures
Torque change
Torque is an expression of the muscular strength and was assessed by dynamometry
Secondary Outcome Measures
Muscular architecture change
Muscular architecture (muscle thickness, pennation angle and fascicle length) was assessed by ultrasonography
Full Information
NCT ID
NCT02308618
First Posted
December 2, 2014
Last Updated
December 2, 2014
Sponsor
Federal University of Rio Grande do Sul
Collaborators
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Conselho Nacional de Desenvolvimento Científico e Tecnológico
1. Study Identification
Unique Protocol Identification Number
NCT02308618
Brief Title
Rehabilitation Programs After Achilles Tendon Rupture
Official Title
Achilles Tendon Rupture: Comparative Study Between Two Rehabilitation Programs.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Rio Grande do Sul
Collaborators
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Conselho Nacional de Desenvolvimento Científico e Tecnológico
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rupture of Achilles Tendon, Immobility Response, Tonic, Rupture, Spontaneous
Keywords
Achilles tendon rupture, Rehabilitation, Immobilization, Muscle architecture, Functionality, Neuromuscular parameters, Weight-Bearing
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
47 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Traditional Immobilization
Arm Type
Experimental
Arm Description
45 days of plaster cast immobilization After the immobilization period, subjects received instructions on how to perform a home-based exercise program
Arm Title
Early mobilization
Arm Type
Experimental
Arm Description
Six weeks of physical therapy program
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Traditional Immobilization
Other Intervention Name(s)
Plaster cast immobilization
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Early Mobilization
Other Intervention Name(s)
Accelerated rehabilitation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Torque change
Description
Torque is an expression of the muscular strength and was assessed by dynamometry
Time Frame
Torque was measured 3 times during the study: three, six and more than 12 months after surgical repair.
Secondary Outcome Measure Information:
Title
Muscular architecture change
Description
Muscular architecture (muscle thickness, pennation angle and fascicle length) was assessed by ultrasonography
Time Frame
Muscle architecture was measured 4 times during the study: 45 days, three, six and more than 12 months after surgical repair.
Other Pre-specified Outcome Measures:
Title
Muscular electrical activation change
Description
Electrical activation was assessed by electromyography (EMG)
Time Frame
Muscular electrical activation was measured 3 times during the study: three, six and more than 12 months after surgical repair
Title
Tendon mechanical and material properties change
Description
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.
Time Frame
Tendon mechanical and material properties were measured 3 times during the study: three, six and more than 12 months after surgical repair.
Title
Functional performance change
Description
Functional performance was assessed by functional tests (standing heel-rise, time up and go and jump tests) and AOFAS questionnaire.
Time Frame
Functional performace was measured 3 times during the study: three, six and more than 12 months after surgical repair
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marco A Vaz, PhD
Organizational Affiliation
Federal University of Rio Grande do Sul
Official's Role
Principal Investigator
Facility Information:
Facility Name
Exercise Research Laboratory, School of Physical Education, Federal University of Rio Grande do Sul
City
Porto Alegre
State/Province
Rio Grande do Sul
ZIP/Postal Code
90690-200
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Rehabilitation Programs After Achilles Tendon Rupture
We'll reach out to this number within 24 hrs