Biomechanical and Ultrasonic Assessment of the Achilles Tendon in Vivo (MEDUSAA)

NCT02567058 | Completed

• 1 other identifier: AORT 2011-FP / MEDUSAA
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alterations of the Achilles Tendon

Keywords

Achilles tendon

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• score IPAQ questionnaire

  up to 3 months

• Examination data

  baseline

• time of hyper stress

  up to 3 months

Study Arms (1)

3 groups of subjects

EXPERIMENTAL

3 groups: * group I : healthy volunters * group II : patient with an immobilisation (between 1 and 2 months) * group III : patient with an antecedent of Achilles tendon breakage during the 10 past years Each group have the same interventions : ultrasound exam, IPAQ questionnaire

Device: Ultrasound exam; Behavioral: IPAQ questionnaire

Interventions

Ultrasound exam DEVICE

Ultrasound exam with : * 2 successions of 3 measures repeated for 2 visits (day 0 and day 21) for group I * 1 succession of 3 measures repeated for 4 visits (day 0, day 14, day 45, day 90)for group II * 1 succession of 3 measures for group III

Also known as: Achillus, Ergometer

3 groups of subjects

IPAQ questionnaire BEHAVIORAL

IPAQ questionnaire

3 groups of subjects

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• Groupe III
• Male
• Between 18 and 60 years-old
• Informed consent form signed
• Affiliated to medical insurance

You may not qualify if:

• 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
• 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 …)

Sponsors & Collaborators

• University Hospital, Tours: lead

Study Sites (1)

Univesity Hospital of Tours

Tours, 37044, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2015
• First Posted: October 2, 2015
• Study Start: December 1, 2012
• Primary Completion: July 1, 2015
• Study Completion: August 1, 2015
• Last Updated: October 2, 2015

Record last verified: 2015-09

Locations

FR (1)