Measurement of the Strength of the Posterior Tibial Muscle by Hand-held Dynamometer (TPHHD)

April 28, 2021 updated by: University Hospital, Lille

Validation of the Measurement of the Strength of the Posterior Tibial Muscle by Hand-held Dynamometer Against a Reference Isokinetic Dynamometer

Adult flat foot valgus is a degenerative pathology that causes damage to the ligaments of the hindfoot as well as dysfunction of the tendon of the posterior tibial muscle.

Currently, there is a lack of a tool allowing a standardized, reliable, reproducible and validated measurement of the strength of the tendon of the posterior tibial muscle in consultation of foot surgery.

The hand-held dynamometer could be that tool. The study would consist in measuring the strength of the tendon of the posterior tibial muscle in healthy subjects with a hand-held dynamometer (MicroFET2) by two examiners and compared to isometric reference measurements (CON-TREX CMV Multi-Joint) to validate the reliability of the measurement and its reproducibility.

Study Overview

Status

Recruiting

Study Type

Interventional

Enrollment (Anticipated)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Lille, France, 59037
        • Recruiting
        • Hop Salengro - Hopital B Chr Lille - Lille

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients from physical medicine and rehabilitation department hospitalized for pathologies other than neurological or osteo-articular pathologies affecting the lower limbs,
  • Having no neurological or osteo-articular pathology affecting the lower limbs f one year,
  • No history of surgery on the rear foot and ankle,
  • Written informed consent from person,
  • Socially insured patient person,
  • Person willing to comply with all study procedures and study duration.

Exclusion Criteria:

  • Neurological or osteo-articular pathologies affecting the lower limbs,
  • Known pathologies of the tendon of the posterior tibialis muscle,
  • Deformations of the foot (flat foot, hollow foot),
  • History of hindfoot or ankle surgery,
  • Pregnant or breastfeeding woman,
  • Inability to receive information, consent and participate in the whole study,
  • Person under judicial protection or deprived of liberty,
  • Person participating in another clinical trial,
  • No social insurance cover,
  • No written consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single group
measuring the strength of the tendon of the posterior tibial muscle in healthy subjects with a hand-held dynamometer by two examiners and with an isometric dynamometer
Posterior tibial tendon strength is assessed with a hand-held dynamometer by two independent observer and with an isometric dynamometer by one observer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intra-class correlation coefficient of the inversion force (or supination measured in Newton) of the foot between the measurement made with the hand dynamometer and the measurement made with the isokinetic dynamometer (gold standard).
Time Frame: on the day of first evaluation (at day 1)
Validity of the measurement of the tendon strength of the posterior tibial muscle with a hand-held dynamometer (MicroFET2) compared to the gold standard (CON-TREX CMV Multi-Joint) in subjects.
on the day of first evaluation (at day 1)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intra-class correlation coefficient of the inversion force of the foot between two measurements made by the same observer with the hand dynamometer (intra-observer reproducibility).
Time Frame: on the day of first evaluation (At day 1) and on the day of second evaluation (at day 2)
the inversion force (or supination measured in Newton). The two measurements will be performed during two consultations one day apart.
on the day of first evaluation (At day 1) and on the day of second evaluation (at day 2)
Intra-class correlation coefficient of the inversion force of the foot between measurements made by two different observers with the hand dynamometer (intra-observer reproducibility).
Time Frame: on the day of first evaluation (At day 1) and on the day of second evaluation (at day 2)
the inversion force (or supination measured in Newton)
on the day of first evaluation (At day 1) and on the day of second evaluation (at day 2)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Thomas Amouyel, MD, University Hospital, Lille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 23, 2021

Primary Completion (Anticipated)

February 1, 2022

Study Completion (Anticipated)

February 1, 2022

Study Registration Dates

First Submitted

December 8, 2020

First Submitted That Met QC Criteria

December 14, 2020

First Posted (Actual)

December 17, 2020

Study Record Updates

Last Update Posted (Actual)

May 3, 2021

Last Update Submitted That Met QC Criteria

April 28, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Valgus Foot Deformity

Clinical Trials on Posterior tibial tendon strength mesure

3
Subscribe