Rupture of Achilles TendonNCT02308618
Rehabilitation Programs After Achilles Tendon Rupture
A study testing Traditional Immobilization and Early Mobilization in people with Rupture of Achilles Tendon and Immobility Response, Tonic, run by Federal University of Rio Grande do Sul at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Rupture of Achilles Tendon, Immobility Response, Tonic, Rupture, Spontaneous
- What is being tested?
- Traditional Immobilization and Early Mobilization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2008to Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male
- Achilles tendon rupture
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Exercise Research Laboratory, School of Physical Education, Federal University of Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, 90690-200
About this study
Official title: 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.
Read the 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.
- Being tested
- Traditional Immobilization, Early Mobilization
- Keywords
- Achilles tendon rupture, Rehabilitation, Immobilization, Muscle architecture, Functionality, Neuromuscular parameters, Weight-Bearing
- Medical subject headings
- Immobility Response, Tonic, Rupture, Spontaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional ImmobilizationOther
Also called Plaster cast immobilization
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
Early MobilizationOther
Also called Accelerated rehabilitation
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Traditional Immobilization |
| Early mobilization | Experimental | Six weeks of physical therapy program Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heel rise test (HRT)
Heel rise height is an expression of ankle plantarflexor functional performance and was assessed using the HRT.
Measured: 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 is an expression of the muscular strength and was assessed by dynamometry
Measured: 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 assessed by goniometry during active and passive dorsiflexion and plantar flexion.
Measured: 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
Muscular architecture (muscle thickness, pennation angle and fascicle length) was assessed by ultrasonography
Measured: 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 estimated from calf muscle thickness and limb length using the equation proposed by Miyatani et al. 2004.
Measured: Plantarflexor muscle volume was assessed 4 times during the study: 45 days, three, six and more than 12 months after surgical repair.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2014 (estimated)
- Study startMar 2008
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rupture of Achilles TendonStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Principal investigator, Marco Aurélio Vaz, PhD, Federal University of Rio Grande do Sul
- Investigators
- Marco A Vaz, PhD, Principal investigator, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02308618
- Sponsor's protocol ID
- UFRGS - 2007882
- Status last verified
- Nov 2024
- First submitted
- 2 Dec 2014
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Achilles Tendon Rupture: Comparative Study Between Two Rehabilitation Programs.
- ClinicalTrials.gov ID
- NCT02308618
- Acronym / sponsor ID
- UFRGS - 2007882
- Keywords
- Achilles tendon rupture, Rehabilitation, Immobilization, Muscle architecture, Functionality, Neuromuscular parameters, Weight-Bearing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Federal University of Rio Grande do SulUniversity, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- Mar 2008
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 4 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Traditional Immobilization | Experimental | Other: Traditional Immobilization45 days of plaster cast immobilization After the immobilization period, subjects received instructions on how to perform a home-based exercise program |
| Early mobilization | Experimental | Other: Early MobilizationSix weeks of physical therapy program |
| 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. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Male
- Achilles tendon rupture
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Traditional ImmobilizationAlso: Plaster cast immobilizationAfter 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 | Traditional Immobilization |
| Early MobilizationAlso: Accelerated rehabilitationThe 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 | Early mobilization |
Primary outcome
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.
4 secondary outcomes
Muscular torque change
Time frame: Torque was measured 3 times during the study: three, six and more than 12 months after surgical repair.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marco A Vaz, PhD principal investigator
Federal University of Rio Grande do Sul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional Immobilization and Early Mobilization in people with Rupture of Achilles Tendon and Immobility Response, Tonic, run by Federal University of Rio Grande do Sul at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.