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

Orthopedic Clinical Trial

— EQUINOM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04792359
• Other study ID #: 2020-A03518-31
• Status: Recruiting
• Phase: N/A
• Start date: April 22, 2021
• Est. completion date: September 10, 2021

Study information

• Verified date: April 2021
• Source: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Contact: Julien BELDAME, MD
• Phone: 33 (0)1 43 37 68 21
• Email: julien.beldame[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 10, 2021
• Est. primary completion date: September 10, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Orthopedic

Intervention

Device:
• Equinometer
Measurement of dorsiflexion of the ankle will be reproduced three times on each ankle in two positions, with a force applied

Locations

Country	Name	City	State
France	Clinique Blomet	Paris

Sponsors (1)

Lead Sponsor	Collaborator
GCS Ramsay Santé pour l'Enseignement et la Recherche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Repeted measures of passive dorsiflexion of ankle using an equinometer at day1	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	Day1 (single visit)