- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04673669
Measurement of the Strength of the Posterior Tibial Muscle by Hand-held Dynamometer (TPHHD)
Validation of the Measurement of the Strength of the Posterior Tibial Muscle by Hand-held Dynamometer Against a Reference Isokinetic 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Thomas Amouyel, MD
- Phone Number: +33 0320445962
- Email: thomas.amouyel@chru-lille.fr
Study Locations
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-
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Lille, France, 59037
- Recruiting
- Hop Salengro - Hopital B Chr Lille - Lille
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Single group
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
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Posterior tibial tendon strength is assessed with a hand-held dynamometer by two independent observer and with an isometric dynamometer by one observer.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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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.
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on the day of first evaluation (at day 1)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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the inversion force (or supination measured in Newton).
The two measurements will be performed during two consultations one day apart.
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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).
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)
|
on the day of first evaluation (At day 1) and on the day of second evaluation (at day 2)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Thomas Amouyel, MD, University Hospital, Lille
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020_60
- 2020-A02675-34 (Other Identifier: ID-RCB number,ANSM)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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