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

NCT04673669 | Completed

• 2 other identifiers: 2020_602020-A02675-34
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Valgus Foot Deformity

Keywords

Posterior tibial; hand-held dynamometer, isokinetics; isokinetics, measurement validation

Outcome Measures

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).

  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 Outcomes (2)

• 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).

  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).

  on the day of first evaluation (At day 1) and on the day of second evaluation (at day 2)

Study Arms (1)

Single group

EXPERIMENTAL

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

Diagnostic Test: Posterior tibial tendon strength mesure

Interventions

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.

Single group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

Hop Salengro - Hopital B Chr Lille - Lille

Lille, 59037, France

Location

MeSH Terms

Conditions

Flatfoot

Condition Hierarchy (Ancestors)

Talipes; Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Thomas Amouyel, MD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2020
• First Posted: December 17, 2020
• Study Start: March 23, 2021
• Primary Completion: March 11, 2022
• Study Completion: March 11, 2022
• Last Updated: December 23, 2025

Record last verified: 2025-12

Locations

FR (1)