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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02307708
Other study ID # RC13_0043
Secondary ID
Status Terminated
Phase N/A
First received July 25, 2014
Last updated December 26, 2017
Start date January 2015
Est. completion date December 2016

Study information

Verified date December 2017
Source Nantes University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of the study is to compare the treatment by wearing shoes inclined at kinesitherapy because it is the first treatment offered by primary care physicians in chronic Achilles tendinopathy.


Recruitment information / eligibility

Status Terminated
Enrollment 16
Est. completion date December 2016
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Age: 18-75 years

- Disease: chronic Achilles tendinopathy de novo or recurrent confirmed by ultrasound

- Patients having signed the informed consent for the study participation

- Patients covered by medical insurance

- Patients having no behavioral disorders

Exclusion Criteria:

- History of rupture of the Achilles tendon (= stage 4)

- Antibiotic treatment tendinotoxique (Quinolones, ...)

- Inability to walk more than 30 minutes per day.

- Haglund Syndrome

- Treatment of tendinopathy or being older than six months

- Minors

- Major trust

Study Design


Intervention

Device:
8° incline shoe
Wearing inclined shoes for 6 weeks, walking 15 minutes (2 times/day). The shoe is inclined from front to back and from top to bottom of 8 °. This causes a controlled and an eccentric contraction during the passage. During the walk we will have: In support tardigrade : an ankle dorsiflexion with a stretching the Achilles tendon (eccentric contractions). In support digitigrade: plantar flexion of ankle with a muscle contraction of triceps surae (concentric contraction).
Other:
kinesitherapy
Daily eccentric contraction at home and once per week for 6 weeks with the physiotherapist

Locations

Country Name City State
France CHU de Nantes Nantes
France Nouvelles cliniques Nantaises Nantes

Sponsors (1)

Lead Sponsor Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evolution of the American Orthopaedic Foot and Ankle Score (AOFAS) at Day 0 and 12 weeks
Secondary Evolution of amplitude to the tibio-tarsal at 12 weeks
Secondary Pain Scores on the Visual Analog Scale at 12 weeks
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