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

NCT02307708 | Terminated

• 1 other identifier: RC13_0043
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 2

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.

Conditions

Tendinopathy; Rupture of Achilles Tendon; Chronic Disease

Outcome Measures

Primary Outcomes (1)

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

  at Day 0 and 12 weeks

Secondary Outcomes (2)

• Evolution of amplitude to the tibio-tarsal

  at 12 weeks

• Pain Scores on the Visual Analog Scale

  at 12 weeks

Study Arms (2)

8° incline shoe

EXPERIMENTAL

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

kinesitherapy

ACTIVE COMPARATOR

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

Other: kinesitherapy

Interventions

8° incline shoe DEVICE

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).

Also known as: Wearing inclined shoes

8° incline shoe

kinesitherapy OTHER

Daily eccentric contraction at home and once per week for 6 weeks with the physiotherapist

Also known as: The kinesitherapy for the treatment of tendinopathy

kinesitherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (2)

CHU de Nantes

Nantes, France

Location

Nouvelles cliniques Nantaises

Nantes, France

Location

MeSH Terms

Conditions

Tendinopathy; Chronic Disease

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Tendon Injuries; Wounds and Injuries; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bertrand Rousseau

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2014
• First Posted: December 4, 2014
• Study Start: January 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 27, 2017

Record last verified: 2017-12

Locations

FR (2)