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Completed

NCT Number: NCT04673669

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

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Key information

Conditions

Valgus Foot Deformity Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Flatfoot Foot Deformities Foot Deformities, Acquired Foot Deformities, Congenital Limb Deformities, Congenital Lower Extremity Deformities, Congenital Musculoskeletal Abnormalities Musculoskeletal Diseases Talipes

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hop Salengro - Hopital B Chr Lille - Lille

Lille, 59037, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Posterior tibial tendon strength mesure

Diagnostic Test

Posterior tibial tendon strength is assessed with a hand-held dynamometer by two independent observer and with an isometric dynamometer by one observer.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  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)

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

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

Acronym: TPHHD

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 17, 2020
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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