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

Primary Purpose

Tendinopathy, Rupture of Achilles Tendon, Chronic Disease

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
8° incline shoe
kinesitherapy
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Tendinopathy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de Nantes
  • Nouvelles cliniques Nantaises

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

8° incline shoe

kinesitherapy

Arm Description

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).

The patient performs its home therapy and consults his physiotherapist once a week according to the protocol Stanish

Outcomes

Primary Outcome Measures

Evolution of the American Orthopaedic Foot and Ankle Score (AOFAS)

Secondary Outcome Measures

Evolution of amplitude to the tibio-tarsal
Pain Scores on the Visual Analog Scale

Full Information

First Posted
July 25, 2014
Last Updated
December 26, 2017
Sponsor
Nantes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02307708
Brief Title
Reeducation of Chronic Achilles Tendinopathy by Wearing Shoes Inclined Versus Reeducation by Kinesitherapy
Acronym
TARCI
Official Title
Reeducation of Chronic Achilles Tendinopathy by Wearing Shoes Inclined Versus Reeducation by Kinesitherapy
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Terminated
Why Stopped
recruitment difficulties (few patients meeting inclusion criteria, refusal of patients to stop sport activities during 6 weeks,...)
Study Start Date
January 2015 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tendinopathy, Rupture of Achilles Tendon, Chronic Disease

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
8° incline shoe
Arm Type
Experimental
Arm Description
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).
Arm Title
kinesitherapy
Arm Type
Active Comparator
Arm Description
The patient performs its home therapy and consults his physiotherapist once a week according to the protocol Stanish
Intervention Type
Device
Intervention Name(s)
8° incline shoe
Other Intervention Name(s)
Wearing inclined shoes
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
kinesitherapy
Other Intervention Name(s)
The kinesitherapy for the treatment of tendinopathy
Intervention Description
Daily eccentric contraction at home and once per week for 6 weeks with the physiotherapist
Primary Outcome Measure Information:
Title
Evolution of the American Orthopaedic Foot and Ankle Score (AOFAS)
Time Frame
at Day 0 and 12 weeks
Secondary Outcome Measure Information:
Title
Evolution of amplitude to the tibio-tarsal
Time Frame
at 12 weeks
Title
Pain Scores on the Visual Analog Scale
Time Frame
at 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bertrand Rousseau
Organizational Affiliation
Nantes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Nantes
City
Nantes
Country
France
Facility Name
Nouvelles cliniques Nantaises
City
Nantes
Country
France

12. IPD Sharing Statement

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Reeducation of Chronic Achilles Tendinopathy by Wearing Shoes Inclined Versus Reeducation by Kinesitherapy

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