Alterations of the Achilles Tendon Clinical Trial
— MEDUSAAOfficial title:
Biomechanical and Ultrasonic Assessment of the Achilles Tendon in Vivo (MEDUSAA)
Among Musculoskeletal disorders (MSD) the rupture of the Achilles tendon is the most common.
Up today, the mechanical and elastic properties of the Achilles tendon are still unknown,
and that both in healthy subjects in pathology. The viscoelastic properties or dynamic
mechanical properties are directly related to the tendon of the health status and its
elongation capacity.
The laboratory UMR Inserm U930 - CNRS ERL 3106 in Tours has developed a non-invasive
ultrasonic device, named Achillus, which, via an ultrasonic probe, allowing to access the
viscoelastic properties of the tendon during the contraction of the sural triceps.
This is what we want to do in this first protocol: in vivo observation of the normal values
and variations, looking for changes related to hyper solicitation and finally trying to
highlight a tendon fragility parameter for patients who have experienced of a Achilles
tendon rupture.
| Status | Completed |
| Enrollment | 62 |
| Est. completion date | August 2015 |
| Est. primary completion date | July 2015 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Male |
| Age group | 18 Years to 60 Years |
| Eligibility |
Inclusion Criteria: Groupe I - Male - Between 18 and 60 years-old - Informed consent form signed - Affiliated to medical insurance Groupe II - Male - Between 18 and 60 years-old - Informed consent form signed - Affiliated to medical insurance - pathology of lower limb, from surgical treatment, and requiring an immobilization longer than one month and lower than two months, with discharge without support. Inclusion in the study will be done during within 48h from the onset of the immobilization Groupe III - Male - Between 18 and 60 years-old - Informed consent form signed - Affiliated to medical insurance - Antecedent of unilateral Achilles tendon breakage during the last 10 years (without breakage during the year previous the inclusion). Exclusion Criteria: Groupe I - Know pathologies of collagen - Antecedent of surgery on studied lower limb, located under the knee - Pathology requiring a relief, a sport stoppage prescribed by a physician for a lower limb pathology during the last 12 months - Muscular or neurologic pathology with impact on lower limbs - Acute pathology able to compromise quality of the research (infectious, organic failure, pain …) - Treatments able to affect the results of the research (myorelaxant, molecule changing the muscular tonus, quinolones …) - Adult under guardianship - Person under an exclusion period of other biomedical research Groupe II - Know pathologies of collagen - Antecedent of surgery on studied lower limb, located under the knee - Pathology requiring a relief, a sport stoppage prescribed by a physician for a lower limb pathology during the last 12 months - Muscular or neurologic pathology with impact on healthy lower limb - Acute pathology able to compromise quality of the research (infectious, organic failure, pain …) - Treatments able to affect the results of the research (myorelaxant, molecule changing the muscular tonus, quinolones …) - Adult under guardianship - Person under an exclusion period of other biomedical research Groupe III - Know pathologies of collagen - Antecedent of surgery on studied lower limb, located under the knee - Pathology requiring a relief, a sport stoppage prescribed by a physician for a lower limb pathology during the last 12 months (including a controlateral Achilles tendon breakage) - Muscular or neurologic pathology with impact on lower limbs - Acute pathology able to compromise quality of the research (infectious, organic failure, pain …) - Treatments able to affect the results of the research (myorelaxant, molecule changing the muscular tonus, quinolones …) - Adult under guardianship - Person under an exclusion period of other biomedical research |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| France | Univesity Hospital of Tours | Tours |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Tours |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Measures of received signals of the ultrasound sensors and measures of applied strength on the pedal during | This is the measure of received signals of the ultrasound sensors and measures of applied strength on the pedal during plantar flexion efforts. Untreated data will be treated to extract this following parameters : Control of rotational strengths couple applied by the participant Simultaneous speed measure of lateral wave along the Achilles tendon The set oh these data will be got with an initial isometric effort at 20, 50, 80% of the de maximal voluntary muscle contraction previously measured |
up to 3 months | No |
| Secondary | score IPAQ questionnaire | Clinical parameter :score questionnaire of average physical activity of persons, determined by IPAQ questionnaire | up to 3 months | No |
| Secondary | Examination data | Examination data : age, size, weight, laterality, smoking history | baseline | No |
| Secondary | time of hyper stress | time of hyper stress | up to 3 months | No |