NCT04792359

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 4, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 10, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

April 22, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2021

Completed
Last Updated

April 26, 2021

Status Verified

April 1, 2021

Enrollment Period

5 months

First QC Date

March 4, 2021

Last Update Submit

April 23, 2021

Conditions

Keywords

Ankle-Dorsiflexion-Reproducibility -Measure-Orthopedic

Outcome Measures

Primary Outcomes (1)

  • 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)

Study Arms (1)

Equinometer

EXPERIMENTAL

Measurement with Equinometer

Device: Equinometer

Interventions

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

Equinometer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique Blomet

Paris, France

RECRUITING

Study Officials

  • Julien BELDAME, MD

    RGDS-Clinique Blomet

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: Exploratory, interventional, prospective, uncontrolled, single arm, monocentric study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2021

First Posted

March 10, 2021

Study Start

April 22, 2021

Primary Completion

September 10, 2021

Study Completion

September 10, 2021

Last Updated

April 26, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations