Ankle InjuriesEntoQuaVieNCT07054892
Assessment of the Quality of Life of Patients Visiting the Emergency Department of the Saint-Brieuc Hospital Following an Ankle Sprain
An observational study of Ankle Injuries and Treatment Outcome, run by Centre Hospitalier de Saint-Brieuc at 1 site in France.
Trial summary
Lateral ankle sprains account for nearly 6,500 emergency department visits per day in France. They are clinically classified into three grades, which can be assessed approximately 3-5 days after an acute sprain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ankle Injuries, Treatment Outcome
- What is being tested?
- FAAM - Activities of Daily Living (ADL) Subscale
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2025to 30 Oct 2025
- Phase
- Observational
- 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
Study population: Participants presenting to the emergency department of Saint-Brieuc for an ankle sprain.
Who may be able to join
- Age ≥ 18 years
- Ankle trauma
- Initial consultation at the emergency department of Saint-Brieuc
Who cannot join
- Surgical treatment following the trauma
- Fracture resulting from the trauma
- Ligament or bone injury to either lower limb (knee, hip, ankle) occurring within 6 months prior to the trauma
- Injury to another joint during the trauma with functional impairment
- Adult under legal protection (guardianship, trusteeship, or judicial protection) or deprived of liberty
- Pregnant woman
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Hospitalier de Saint-Brieuc - Paimpol - Tréguier
Saint-Brieuc, 22000
About this study
Official title: EntoQuaVie - Assessment of the Quality of Life of Patients Visiting the Emergency Department of the Saint-Brieuc Hospital Following an Ankle Sprain: A Follow-up-based Evaluation Considering the Severity Grade of the Ankle Sprain
Lateral ankle sprains account for nearly 6,500 emergency department visits per day in France. They are clinically classified into three grades, which can be assessed approximately 3-5 days after an acute sprain. However, this classification remains somewhat approximate, with only mild and severe sprains being reliably identified.
When it comes to immobilization, if weight-bearing is possible, treatment options include an elastic ankle brace for mild sprains, taping, or a semi-rigid orthosis known as a "stabilizing" brace. It is worth noting that, according to Rodineau and Besch, the preferred form of immobilization is the semi-rigid orthosis. In cases of severe sprains where weight-bearing is not possible, rigid immobilization may be used.
Read more
To date, few thesis-level studies have focused on trauma care and the outpatient follow-up of ankle sprains. Two studies from the early 2010s assessed general practice management of trauma using questionnaires-one in Seine-Maritime and another in Bouches-du-Rhône. The latter study found that 96.7% of surveyed physicians reported managing all types of sprains. In the Seine-Maritime study, half of the physicians systematically followed up on ankle sprains, while the other half only did so if the patient's condition worsened. It was also found that nearly 47% of physicians referred their patients directly to emergency departments. This pathway was more frequently chosen by urban practitioners or those without specific training in trauma care.
Except in certain predefined cases depending on the hospital, there is currently no systematic follow-up for ankle sprains in emergency departments. Most patients are redirected toward follow-up in outpatient care.
The objective of this research project is to assess the recovery of baseline quality of life in participants who consulted the emergency department of Saint-Brieuc for an ankle sprain, three months after the injury. The evaluation will take into account the type of follow-up care (physician, physiotherapist) as well as the severity of the sprain.
Read the detailed description
The FAAM-ADL questionnaire is a self-assessment tool and will be completed for the first time upon the participant's arrival at the emergency department. The responses will be based on the participant's recollection of their functional ability and quality of life prior to the ankle injury.
A second self-assessment will be conducted at the 3-month mark, using the same FAAM-ADL scale, either by email or phone. This time, the questionnaire will focus on their current functional ability and quality of life. By comparing these two sets of responses, it will be possible to evaluate the degree of recovery three months after the ankle sprain, relative to their pre-injury baseline.
The severity grade of the sprain will be determined based on the clinical data recorded by the physician during the initial emergency consultation, following review of the medical records by the coordinating investigator.
- Conditions
- Ankle Injuries, Treatment Outcome
- Being tested
- FAAM - Activities of Daily Living (ADL) Subscale
- Keywords
- ankle injuries, emergency department, patient follow-up
- Medical subject headings
- Ankle Injuries, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FAAM - Activities of Daily Living (ADL) SubscaleBehavioural
The FAAM score is scientifically validated and allows for the assessment of foot and ankle functional ability
| Study group | Role | What they receive |
|---|---|---|
| Participants with ankle sprain | Participants presenting to the emergency department of Saint-Brieuc for an ankle sprain Receives: Behavioral: FAAM - Activities of Daily Living (ADL) Subscale |
What is being measured
The primary outcome is the main question the study is designed to answer.
FAAM ADL questionnaire
The FAAM-ADL questionnaire is the first subscale of the FAAM questionnaire. It consists of 21 items and is used to assess activities of daily living. Each item is rated on a scale from 0 to 4 (0: unable to perform the activity; 4: no difficulty performing the activity).
Measured: At inclusion in the study and 3 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start1 Apr 2025
- Primary completion30 Oct 2025
- Study completion30 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle InjuriesStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Saint-Brieuc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07054892
- Sponsor's protocol ID
- 2024_CHSB_EntoQuaVie
- Other IDs
- 2024-A02526-41
- Acronym
- EntoQuaVie
- Status last verified
- Oct 2026
- First submitted
- 27 Jun 2025
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EntoQuaVie - Assessment of the Quality of Life of Patients Visiting the Emergency Department of the Saint-Brieuc Hospital Following an Ankle Sprain: A Follow-up-based Evaluation Considering the Severity Grade of the Ankle Sprain
- ClinicalTrials.gov ID
- NCT07054892
- Acronym / sponsor ID
- EntoQuaVie / 2024_CHSB_EntoQuaVie
- Conditions
- Ankle Injuries, Treatment Outcome
- Keywords
- ankle injuries, emergency department, patient follow-up
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Centre Hospitalier de Saint-BrieucUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 30 Oct 2025 (actual)
- Study completion
- 30 Oct 2025 (actual)
- First posted
- 8 Jul 2025 (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.
Lateral ankle sprains account for nearly 6,500 emergency department visits per day in France. They are clinically classified into three grades, which can be assessed approximately 3-5 days after an acute sprain. However, this classification remains somewhat approximate, with only mild and severe sprains being reliably identified.
When it comes to immobilization, if weight-bearing is possible, treatment options include an elastic ankle brace for mild sprains, taping, or a semi-rigid orthosis known as a "stabilizing" brace. It is worth noting that, according to Rodineau and Besch, the preferred form of immobilization is the semi-rigid orthosis. In cases of severe sprains where weight-bearing is not possible, rigid immobilization may be used.
To date, few thesis-level studies have focused on trauma care and the outpatient follow-up of ankle sprains. Two studies from the early 2010s assessed general practice management of trauma using questionnaires-one in Seine-Maritime and another in Bouches-du-Rhône. The latter study found that 96.7% of surveyed physicians reported managing all types of sprains. In the Seine-Maritime study, half of the physicians systematically followed up on ankle sprains, while the other half only did so if the patient's condition worsened. It was also found that nearly 47% of physicians referred their patients directly to emergency departments. This pathway was more frequently chosen by urban practitioners or those without specific training in trauma care.
Except in certain predefined cases depending on the hospital, there is currently no systematic follow-up for ankle sprains in emergency departments. Most patients are redirected toward follow-up in outpatient care.
The objective of this research project is to assess the recovery of baseline quality of life in participants who consulted the emergency department of Saint-Brieuc for an ankle sprain, three months after the injury. The evaluation will take into account the type of follow-up care (physician, physiotherapist) as well as the severity of the sprain.
Detailed description
The FAAM-ADL questionnaire is a self-assessment tool and will be completed for the first time upon the participant's arrival at the emergency department. The responses will be based on the participant's recollection of their functional ability and quality of life prior to the ankle injury.
A second self-assessment will be conducted at the 3-month mark, using the same FAAM-ADL scale, either by email or phone. This time, the questionnaire will focus on their current functional ability and quality of life. By comparing these two sets of responses, it will be possible to evaluate the degree of recovery three months after the ankle sprain, relative to their pre-injury baseline.
The severity grade of the sprain will be determined based on the clinical data recorded by the physician during the initial emergency consultation, following review of the medical records by the coordinating investigator.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with ankle sprain | – | Behavioral: FAAM - Activities of Daily Living (ADL) SubscaleParticipants presenting to the emergency department of Saint-Brieuc for an ankle sprain |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants presenting to the emergency department of Saint-Brieuc for an ankle sprain.
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Ankle trauma
- Initial consultation at the emergency department of Saint-Brieuc
Key exclusion criteria (6 listed)
- Surgical treatment following the trauma
- Fracture resulting from the trauma
- Ligament or bone injury to either lower limb (knee, hip, ankle) occurring within 6 months prior to the trauma
- Injury to another joint during the trauma with functional impairment
- Adult under legal protection (guardianship, trusteeship, or judicial protection) or deprived of liberty
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 |
|---|---|---|
| FAAM - Activities of Daily Living (ADL) SubscaleThe FAAM score is scientifically validated and allows for the assessment of foot and ankle functional ability | Behavioural | Participants with ankle sprain |
Primary outcome
FAAM ADL questionnaire
Time frame: At inclusion in the study and 3 months later
The FAAM-ADL questionnaire is the first subscale of the FAAM questionnaire. It consists of 21 items and is used to assess activities of daily living. Each item is rated on a scale from 0 to 4 (0: unable to perform the activity; 4: no difficulty performing the activity).
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 22 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ankle Injuries and Treatment Outcome, run by Centre Hospitalier de Saint-Brieuc 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 3 inclusion and 6 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 22 Oct 2026. 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?
FAAM ADL questionnaire (time frame: At inclusion in the study and 3 months later). 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 22 Oct 2026.