OrthopedicEQUINOMNCT04792359
Intra and Inter- Observer Reproducibility of Ankle Dorsiflexion Measure With a New Tool
A study testing Equinometer in people with Orthopedic, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
The Achilles' tendon is the largest and most resistant tendon in the body. When the triceps contracts, the Achilles' tendon is responsible for plantar flexion of the ankle. When the triceps are not contracted, the Achilles tendon is the main component in limiting dorsiflexion of the ankle, a major component of the… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Orthopedic
- What is being tested?
- Equinometer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 22 Apr 2021to 10 Sep 2021
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Man or woman, aged 18 years and more
- Student at the IFMK school (Paris)
- Participant without any trauma at the Achilles' tendon
- Participant who has been given appropriate information about the study objectives and who has given his/her express written and informed consent prior to conduct any study-related procedures.
Who cannot join
- Participant with a traumatic history of one of the two Achilles tendons
- Participant whose physical and / or psychological health is severely impaired, which according to the investigator may affect the participant's compliance with the study
Trial locations and contacts
1 site in 1 country.
About this study
The Achilles' tendon is the largest and most resistant tendon in the body. When the triceps contracts, the Achilles' tendon is responsible for plantar flexion of the ankle. When the triceps are not contracted, the Achilles tendon is the main component in limiting dorsiflexion of the ankle, a major component of the gait pattern. The limitation of this dorsiflexion of the ankle can be caused by a shortening of the Achilles tendon.
This equine whose prevalence in the general population is greater than 50% according to Kowalski, appears to be a risk factor in many pathologies of the foot and ankle.
Currently, in clinical practice, the measurement of passive dorsiflexion of the ankle is empirically measured by the Silfverskiold test. However, the definition of a retraction varies according to the authors, in particular because of the absence of normalization of the force applied on the forefoot, or of the absence of uniformization of the angulation applied. This research is based on the hypothesis that a new measurement tool would be more efficient and more reproducible for measuring dorsiflexion of the ankle.
Read the detailed description
The study includes the measure of dorsiflexion of the ankle with a new tool on volunteers. The measurement will be reproduced three times on each ankle in two positions, with a force applied by three different persons. The measurement will be automatically recorded then analyzed.
- Conditions
- Orthopedic
- Being tested
- Equinometer
- Keywords
- Ankle-Dorsiflexion-Reproducibility -Measure-Orthopedic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EquinometerDevice
Measurement of dorsiflexion of the ankle will be reproduced three times on each ankle in two positions, with a force applied
| Study group | Role | What they receive |
|---|---|---|
| Equinometer | Experimental | Measurement with Equinometer Receives: Device: Equinometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Repeted measures of passive dorsiflexion of ankle using an equinometer at day1
measure defined by the angulation / force couple (degree / newton) in two positions of knee with three forces applied by three different persons using an equinometer including a dynanometer and a goniometer (both measurement automatically registred during the movement) at Day 1
Measured: Day1 (single visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start22 Apr 2021
- Primary completion10 Sep 2021 (estimated)
- Study completion10 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OrthopedicStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Exploratory, interventional, prospective, uncontrolled, single arm, monocentric study
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julien BELDAME, MD, Principal investigator, RGDS-Clinique Blomet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04792359
- Sponsor's protocol ID
- 2020-A03518-31
- Acronym
- EQUINOM
- Status last verified
- Apr 2021
- First submitted
- 4 Mar 2021
- Last updated
- 26 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra and Inter- Observer Reproducibility of Ankle Dorsiflexion Measure With a New Tool
- ClinicalTrials.gov ID
- NCT04792359
- Acronym / sponsor ID
- EQUINOM / 2020-A03518-31
- Conditions
- Orthopedic
- Keywords
- Ankle-Dorsiflexion-Reproducibility -Measure-Orthopedic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- 22 Apr 2021 (actual)
- Primary completion
- 10 Sep 2021 (estimated)
- Study completion
- 10 Sep 2021 (estimated)
- First posted
- 10 Mar 2021 (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.
The Achilles' tendon is the largest and most resistant tendon in the body. When the triceps contracts, the Achilles' tendon is responsible for plantar flexion of the ankle. When the triceps are not contracted, the Achilles tendon is the main component in limiting dorsiflexion of the ankle, a major component of the gait pattern. The limitation of this dorsiflexion of the ankle can be caused by a shortening of the Achilles tendon.
This equine whose prevalence in the general population is greater than 50% according to Kowalski, appears to be a risk factor in many pathologies of the foot and ankle.
Currently, in clinical practice, the measurement of passive dorsiflexion of the ankle is empirically measured by the Silfverskiold test. However, the definition of a retraction varies according to the authors, in particular because of the absence of normalization of the force applied on the forefoot, or of the absence of uniformization of the angulation applied. This research is based on the hypothesis that a new measurement tool would be more efficient and more reproducible for measuring dorsiflexion of the ankle.
Detailed description
The study includes the measure of dorsiflexion of the ankle with a new tool on volunteers. The measurement will be reproduced three times on each ankle in two positions, with a force applied by three different persons. The measurement will be automatically recorded then analyzed.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Exploratory, interventional, prospective, uncontrolled, single arm, monocentric study
| Arm | Type | Receives |
|---|---|---|
| Equinometer | Experimental | Device: EquinometerMeasurement with Equinometer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Man or woman, aged 18 years and more
- Student at the IFMK school (Paris)
- Participant without any trauma at the Achilles' tendon
- Participant who has been given appropriate information about the study objectives and who has given his/her express written and informed consent prior to conduct any study-related procedures.
Key exclusion criteria (2 listed)
- Participant with a traumatic history of one of the two Achilles tendons
- Participant whose physical and / or psychological health is severely impaired, which according to the investigator may affect the participant's compliance with the study
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 |
|---|---|---|
| EquinometerMeasurement of dorsiflexion of the ankle will be reproduced three times on each ankle in two positions, with a force applied | Device | Equinometer |
Primary outcome
Repeted measures of passive dorsiflexion of ankle using an equinometer at day1
Time frame: Day1 (single visit)
measure defined by the angulation / force couple (degree / newton) in two positions of knee with three forces applied by three different persons using an equinometer including a dynanometer and a goniometer (both measurement automatically registred during the movement) at Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2021.
- Individual participant dataSharing planned: No
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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.
Julien BELDAME, MD principal investigator
RGDS-Clinique Blomet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Equinometer in people with Orthopedic, run by GCS Ramsay Santé pour l'Enseignement et la Recherche 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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 26 Apr 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julien BELDAME, MD (33 (0)1 43 37 68 21, julien.beldame@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Repeted measures of passive dorsiflexion of ankle using an equinometer at day1 (time frame: Day1 (single visit)). 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 26 Apr 2021.