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

Primary Purpose

Valgus Foot Deformity

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Posterior tibial tendon strength mesure
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Valgus Foot Deformity focused on measuring Posterior tibial, hand-held dynamometer, isokinetics, isokinetics, measurement validation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hop Salengro - Hopital B Chr Lille - LilleRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single group

Arm Description

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

Outcomes

Primary Outcome Measures

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).
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.

Secondary Outcome Measures

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).
the inversion force (or supination measured in Newton). The two measurements will be performed during two consultations one day apart.
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).
the inversion force (or supination measured in Newton)

Full Information

First Posted
December 8, 2020
Last Updated
April 28, 2021
Sponsor
University Hospital, Lille
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1. Study Identification

Unique Protocol Identification Number
NCT04673669
Brief Title
Measurement of the Strength of the Posterior Tibial Muscle by Hand-held Dynamometer
Acronym
TPHHD
Official Title
Validation of the Measurement of the Strength of the Posterior Tibial Muscle by Hand-held Dynamometer Against a Reference Isokinetic Dynamometer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 23, 2021 (Actual)
Primary Completion Date
February 2022 (Anticipated)
Study Completion Date
February 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Valgus Foot Deformity
Keywords
Posterior tibial, hand-held dynamometer, isokinetics, isokinetics, measurement validation

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
46 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single group
Arm Type
Experimental
Arm Description
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
Intervention Type
Diagnostic Test
Intervention Name(s)
Posterior tibial tendon strength mesure
Intervention Description
Posterior tibial tendon strength is assessed with a hand-held dynamometer by two independent observer and with an isometric dynamometer by one observer.
Primary Outcome Measure Information:
Title
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).
Description
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.
Time Frame
on the day of first evaluation (at day 1)
Secondary Outcome Measure Information:
Title
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).
Description
the inversion force (or supination measured in Newton). The two measurements will be performed during two consultations one day apart.
Time Frame
on the day of first evaluation (At day 1) and on the day of second evaluation (at day 2)
Title
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).
Description
the inversion force (or supination measured in Newton)
Time Frame
on the day of first evaluation (At day 1) and on the day of second evaluation (at day 2)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas Amouyel, MD
Phone
0320445962
Ext
+33
Email
thomas.amouyel@chru-lille.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Amouyel, MD
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hop Salengro - Hopital B Chr Lille - Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Individual Site Status
Recruiting
Facility Contact:
Phone
0320445962

12. IPD Sharing Statement

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

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