Reeducation of Chronic Achilles Tendinopathy by Wearing Shoes Inclined Versus Reeducation by Kinesitherapy (TARCI)

December 26, 2017 updated by: Nantes University Hospital
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nantes, France
        • CHU de Nantes
      • Nantes, France
        • Nouvelles Cliniques Nantaises

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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).
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 Names:
  • Wearing inclined shoes
Active Comparator: kinesitherapy
The patient performs its home therapy and consults his physiotherapist once a week according to the protocol Stanish
Other: kinesitherapy
Daily eccentric contraction at home and once per week for 6 weeks with the physiotherapist
Other Names:
  • The kinesitherapy for the treatment of tendinopathy

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
at Day 0 and 12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Evolution of amplitude to the tibio-tarsal
Time Frame: at 12 weeks
at 12 weeks
Pain Scores on the Visual Analog Scale
Time Frame: at 12 weeks
at 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Investigators

  • Principal Investigator: Bertrand Rousseau, CHU Nantes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

July 25, 2014

First Submitted That Met QC Criteria

December 1, 2014

First Posted (Estimate)

December 4, 2014

Study Record Updates

Last Update Posted (Actual)

December 27, 2017

Last Update Submitted That Met QC Criteria

December 26, 2017

Last Verified

December 1, 2017

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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