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

Valgus Foot Deformity Clinical Trial

— TPHHD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04673669
• Other study ID #: 2020_60
• Secondary ID: 2020-A02675-34
• Status: Recruiting
• Phase: N/A
• Start date: March 23, 2021
• Est. completion date: February 2022

Study information

• Verified date: April 2021
• Source: University Hospital, Lille
• Contact: Thomas Amouyel, MD
• Phone: 0320445962
• Email: thomas.amouyel[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: February 2022
• Est. primary completion date: February 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Foot Deformities
• Valgus Foot Deformity

Intervention

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

Locations

Country	Name	City	State
France	Hop Salengro - Hopital B Chr Lille - Lille	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	on the day of first evaluation (At day 1) and on the day of second evaluation (at day 2)
Secondary	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)	on the day of first evaluation (At day 1) and on the day of second evaluation (at day 2)