- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02307708
Reeducation of Chronic Achilles Tendinopathy by Wearing Shoes Inclined Versus Reeducation by Kinesitherapy (TARCI)
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Nantes, France
- CHU de Nantes
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Nantes, France
- Nouvelles Cliniques Nantaises
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 8° incline shoe
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). |
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 Names:
|
Active Comparator: kinesitherapy
The patient performs its home therapy and consults his physiotherapist once a week according to the protocol Stanish
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Daily eccentric contraction at home and once per week for 6 weeks with the physiotherapist
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Evolution of the American Orthopaedic Foot and Ankle Score (AOFAS)
Time Frame: at Day 0 and 12 weeks
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at Day 0 and 12 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Evolution of amplitude to the tibio-tarsal
Time Frame: at 12 weeks
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at 12 weeks
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Pain Scores on the Visual Analog Scale
Time Frame: at 12 weeks
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at 12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Bertrand Rousseau, CHU Nantes
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC13_0043
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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