Valgus Foot DeformityTPHHDNCT04673669
Measurement of the Strength of the Posterior Tibial Muscle by Hand-held Dynamometer
A study testing Posterior tibial tendon strength mesure in people with Valgus Foot Deformity, run by University Hospital, Lille at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Valgus Foot Deformity
- What is being tested?
- Posterior tibial tendon strength mesure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteFrance
- Study dates
- 23 Mar 2021to 11 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
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- Person under judicial protection or deprived of liberty,
- Person participating in another clinical trial,
- No social insurance cover,
- No written consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Valgus Foot Deformity
- Being tested
- Posterior tibial tendon strength mesure
- Keywords
- Posterior tibial, hand-held dynamometer, isokinetics, isokinetics, measurement validation
- Medical subject headings
- Flatfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posterior tibial tendon strength mesureDiagnostic test
Posterior tibial tendon strength is assessed with a hand-held dynamometer by two independent observer and with an isometric dynamometer by one observer.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Posterior tibial tendon strength mesure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
the inversion force (or supination measured in Newton). The two measurements will be performed during two consultations one day apart.
Measured: 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).
the inversion force (or supination measured in Newton)
Measured: on the day of first evaluation (At day 1) and on the day of second evaluation (at day 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start23 Mar 2021
- Primary completion11 Mar 2022
- Study completion11 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Valgus Foot DeformityStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Amouyel, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04673669
- Sponsor's protocol ID
- 2020_60
- Other IDs
- 2020-A02675-34
- Acronym
- TPHHD
- Status last verified
- Dec 2025
- First submitted
- 8 Dec 2020
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Measurement of the Strength of the Posterior Tibial Muscle by Hand-held Dynamometer Against a Reference Isokinetic Dynamometer
- ClinicalTrials.gov ID
- NCT04673669
- Acronym / sponsor ID
- TPHHD / 2020_60
- Conditions
- Valgus Foot Deformity
- Keywords
- Posterior tibial, hand-held dynamometer, isokinetics, isokinetics, measurement validation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 23 Mar 2021 (actual)
- Primary completion
- 11 Mar 2022 (actual)
- Study completion
- 11 Mar 2022 (actual)
- First posted
- 17 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single group | Experimental | Diagnostic Test: Posterior tibial tendon strength mesuremeasuring 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (10 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Posterior tibial tendon strength mesurePosterior tibial tendon strength is assessed with a hand-held dynamometer by two independent observer and with an isometric dynamometer by one observer. | Diagnostic test | Single group |
Primary outcome
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.
2 secondary outcomes
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Amouyel, MD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Posterior tibial tendon strength mesure in people with Valgus Foot Deformity, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). (time frame: on the day of first evaluation (at day 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.