Rehabilitation Programs After Achilles Tendon Rupture

Rupture, Spontaneous Clinical Trial

Official title:

Achilles Tendon Rupture: Comparative Study Between Two Rehabilitation Programs.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02308618
• Other study ID #: UFRGS - 2007882
• Status: Completed
• Phase: N/A
• First received: December 2, 2014
• Last updated: December 2, 2014
• Start date: March 2008
• Est. completion date: August 2014

Study information

• Verified date: December 2014
• Source: Federal University of Rio Grande do Sul
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Associação Fundo de Incentivo à PesquisaBrazil: Ethics CommitteeBrazil: Ministry of HealthBrazil: National Committee of Ethics in ResearchBrazil: National Health Surveillance Agency
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 30 Years to 60 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Other:
• Traditional 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 Mobilization
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.

Locations

Country	Name	City	State
Brazil	Exercise Research Laboratory, School of Physical Education, Federal University of Rio Grande do Sul	Porto Alegre	Rio Grande do Sul

Sponsors (3)

Lead Sponsor	Collaborator
Federal University of Rio Grande do Sul	Conselho Nacional de Desenvolvimento Científico e Tecnológico, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Muscular electrical activation change	Electrical activation was assessed by electromyography (EMG)	Muscular electrical activation was measured 3 times during the study: three, six and more than 12 months after surgical repair	Yes
Other	Tendon mechanical and material properties change	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.	Tendon mechanical and material properties were measured 3 times during the study: three, six and more than 12 months after surgical repair.	Yes
Other	Functional performance change	Functional performance was assessed by functional tests (standing heel-rise, time up and go and jump tests) and AOFAS questionnaire.	Functional performace was measured 3 times during the study: three, six and more than 12 months after surgical repair	Yes
Primary	Torque change	Torque is an expression of the muscular strength and was assessed by dynamometry	Torque was measured 3 times during the study: three, six and more than 12 months after surgical repair.	Yes
Secondary	Muscular architecture change	Muscular architecture (muscle thickness, pennation angle and fascicle length) was assessed by ultrasonography	Muscle architecture was measured 4 times during the study: 45 days, three, six and more than 12 months after surgical repair.	Yes