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Intra and Inter- Observer Reproducibility of Ankle Dorsiflexion Measure With a New Tool (EQUINOM)

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ClinicalTrials.gov Identifier: NCT04792359
Recruitment Status : Recruiting
First Posted : March 10, 2021
Last Update Posted : April 26, 2021
Sponsor:
Information provided by (Responsible Party):
GCS Ramsay Santé pour l'Enseignement et la Recherche

Brief Summary:

The Achilles' tendon is the largest and most resistant tendon in the body. When the triceps contracts, the Achilles' tendon is responsible for plantar flexion of the ankle. When the triceps are not contracted, the Achilles tendon is the main component in limiting dorsiflexion of the ankle, a major component of the gait pattern. The limitation of this dorsiflexion of the ankle can be caused by a shortening of the Achilles tendon.

This equine whose prevalence in the general population is greater than 50% according to Kowalski, appears to be a risk factor in many pathologies of the foot and ankle.

Currently, in clinical practice, the measurement of passive dorsiflexion of the ankle is empirically measured by the Silfverskiold test. However, the definition of a retraction varies according to the authors, in particular because of the absence of normalization of the force applied on the forefoot, or of the absence of uniformization of the angulation applied. This research is based on the hypothesis that a new measurement tool would be more efficient and more reproducible for measuring dorsiflexion of the ankle.


Condition or disease Intervention/treatment Phase
Orthopedic Device: Equinometer Not Applicable

Detailed Description:
The study includes the measure of dorsiflexion of the ankle with a new tool on volunteers. The measurement will be reproduced three times on each ankle in two positions, with a force applied by three different persons. The measurement will be automatically recorded then analyzed.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Exploratory, interventional, prospective, uncontrolled, single arm, monocentric study
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Intra and Inter- Observer Reproducibility of Ankle Dorsiflexion Measure With a New Tool
Actual Study Start Date : April 22, 2021
Estimated Primary Completion Date : September 10, 2021
Estimated Study Completion Date : September 10, 2021

Arm Intervention/treatment
Experimental: Equinometer
Measurement with Equinometer
Device: Equinometer
Measurement of dorsiflexion of the ankle will be reproduced three times on each ankle in two positions, with a force applied




Primary Outcome Measures :
  1. Repeted measures of passive dorsiflexion of ankle using an equinometer at day1 [ Time Frame: Day1 (single visit) ]
    measure defined by the angulation / force couple (degree / newton) in two positions of knee with three forces applied by three different persons using an equinometer including a dynanometer and a goniometer (both measurement automatically registred during the movement) at Day 1



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Man or woman, aged 18 years and more
  • Student at the IFMK school (Paris)
  • Participant without any trauma at the Achilles' tendon
  • Participant who has been given appropriate information about the study objectives and who has given his/her express written and informed consent prior to conduct any study-related procedures.

Exclusion Criteria:

  • Participant with a traumatic history of one of the two Achilles tendons
  • Participant whose physical and / or psychological health is severely impaired, which according to the investigator may affect the participant's compliance with the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04792359


Contacts
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Contact: Julien BELDAME, MD 33 (0)1 43 37 68 21 julien.beldame@gmail.com

Locations
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France
Clinique Blomet Recruiting
Paris, France
Contact: Julien Beldame, MD         
Sponsors and Collaborators
GCS Ramsay Santé pour l'Enseignement et la Recherche
Investigators
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Principal Investigator: Julien BELDAME, MD RGDS-Clinique Blomet
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Responsible Party: GCS Ramsay Santé pour l'Enseignement et la Recherche
ClinicalTrials.gov Identifier: NCT04792359    
Other Study ID Numbers: 2020-A03518-31
First Posted: March 10, 2021    Key Record Dates
Last Update Posted: April 26, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by GCS Ramsay Santé pour l'Enseignement et la Recherche:
Ankle-Dorsiflexion-Reproducibility -Measure-Orthopedic