Clinical trial NCT04673669: Measurement of the Strength of the Posterior Tibial Muscle by Hand-held Dynamometer
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
Overall status: UNKNOWN
Phase: NA
Conditions: Valgus Foot Deformity
Keywords: Posterior tibial
hand-held dynamometer, isokinetics
isokinetics, measurement validation
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2020-12-17
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: 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).
timeFrame: on the day of first evaluation (at day 1)
Secondary outcomes:
measure: 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).
timeFrame: on the day of first evaluation (At day 1) and on the day of second evaluation (at day 2)
measure: 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).
timeFrame: on the day of first evaluation (At day 1) and on the day of second evaluation (at day 2)
Other outcomes:
Locations:
city: Lille
country: France
facility: Hop Salengro - Hopital B Chr Lille - Lille
Study officials:
affiliation: University Hospital, Lille
name: Thomas Amouyel, MD
role: PRINCIPAL_INVESTIGATOR
References: