Ankle SprainsANKHEALNCT06657937
Evaluation of the Recovery Experienced by Patients After an Ankle Sprain Treated in the Emergency Department of Nantes University Hospital
An observational study of Ankle Sprains, run by Nantes University Hospital at 1 site in France.
Trial summary
To evaluate the recovery experienced by patients with ankle sprains treated in the adult emergency department of Nantes University Hospital. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Ankle Sprains
- What is being tested?
- Questionnaire
- How many people
- 101 participants
- Where
- 1 siteFrance
- Study dates
- 28 Nov 2024to 6 Jun 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of patients admitted to adult emergency departments with ankle sprains.
Who may be able to join
- Patient over 18 years of age
- Presenting an isolated ankle sprain
- Visiting Nantes CHU emergency department for this reason
- Patient able to read and speak French
- Patient covered by a social security scheme
Who cannot join
- Patient > 70 years old
- Patients requiring hospitalization following a visit to the emergency department
- Any intercurrent pathology that may affect the management of the ankle sprain
- Associated ankle fracture
- Patients under legal protection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ANKHEAL - Evaluation of the Recovery Experienced by Patients After an Ankle Sprain Treated in the Emergency Department of Nantes University Hospital
To evaluate the recovery experienced by patients with ankle sprains treated in the adult emergency department of Nantes University Hospital.
Read the detailed description
The aim of this study is therefore to establish the current situation by describing the practices of doctors working in the adult emergency department of the Nantes University Hospital regarding the initial treatment of ankle sprains, and to assess the rate of recovery experienced by patients one month after their trauma. This preliminary study may be pursued in the future, with a view to proposing new recommendations for the management of ankle sprains in the emergency department.
- Conditions
- Ankle Sprains
- Being tested
- Questionnaire
- Keywords
- Emergency, Healing, Ankle, Sprain
- Medical subject headings
- Ankle Injuries, Emergencies, Sprains and Strains
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Also called Phone call
An initial questionnaire is completed on D0, the day of the patient's admission to the emergency department, by the practitioner in charge of the patient, and covers the patient's anamnesis, clinical examination, radiological examinations and treatment.
A follow-up telephone visit is then carried out at 30 days by an investigator, to gather information on the clinical and therapeutic evolution, and to evaluate the recovery and evolution of symptoms experienced by the patient in relation to the initial management.
| Study group | Role | What they receive |
|---|---|---|
| Study population | The study population must correspond to the research inclusion criteria:
Adult patients admitted to the emergency department, presenting with an ankle sprain Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the recovery experienced by patients with ankle sprains treated in the adult emergency department of Nantes University Hospital.
Percentage of patients feeling fully cured at D30
Measured: 30 days
Secondary outcomes (8)
Compare healing sensation with different types of immobilization
Rate of patients feeling fully healed at D30 according to type of immobilization
Measured: 30 days
Compare healing sensation with duration of immobilization
Rate of patients feeling fully healed at D30 according to length of immobilization
Measured: 30 days
Compare the feeling of healing with the initial analgesic proposed
Rate of patients feeling fully healed at D30 according to initial analgesia proposed
Measured: 30 days
Comparing the feeling of recovery according to whether or not a state-certified physiotherapist was involved in the treatment
Rate of patients feeling fully healed at D30 according to whether or not they were treated by a state-qualified physiotherapist
Measured: 30 days
Compare the feeling of recovery according to the presence or absence of early medical reassessment
Rate of patients feeling fully cured at D30 according to the presence or absence of an early medical reassessment
Measured: 30 days
Identify discharge prescription patterns of patients admitted for ankle sprains
Prescription rates for each of the immobilization, analgesia and remote consultation modalities
Measured: 30 days
Identify patients who finally received an alternative diagnosis
Rate of patients receiving an alternative diagnosis
Measured: 30 days
Assessing patients' quality of life at D30 after an ankle sprain
Measurement of median and interquartile range of EQ-5D-5L (EuroQol 5 Dimensions 5 Levels) questionnaire results. The scale ranges from 5 (worst possible health state) to 1 (best possible health state).
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2024
- Study start28 Nov 2024
- Primary completion7 May 2025
- Study completion6 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle SprainsStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06657937
- Sponsor's protocol ID
- RC24_0524
- Acronym
- ANKHEAL
- Status last verified
- Jun 2025
- First submitted
- 23 Oct 2024
- Last updated
- 12 Jun 2025
- 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 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ANKHEAL - Evaluation of the Recovery Experienced by Patients After an Ankle Sprain Treated in the Emergency Department of Nantes University Hospital
- ClinicalTrials.gov ID
- NCT06657937
- Acronym / sponsor ID
- ANKHEAL / RC24_0524
- Conditions
- Ankle Sprains
- Keywords
- Emergency, Healing, Ankle, Sprain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 28 Nov 2024 (actual)
- Primary completion
- 7 May 2025 (actual)
- Study completion
- 6 Jun 2025 (actual)
- First posted
- 26 Oct 2024 (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.
To evaluate the recovery experienced by patients with ankle sprains treated in the adult emergency department of Nantes University Hospital.
Detailed description
The aim of this study is therefore to establish the current situation by describing the practices of doctors working in the adult emergency department of the Nantes University Hospital regarding the initial treatment of ankle sprains, and to assess the rate of recovery experienced by patients one month after their trauma. This preliminary study may be pursued in the future, with a view to proposing new recommendations for the management of ankle sprains in the emergency department.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study population | – | Other: QuestionnaireThe study population must correspond to the research inclusion criteria: Adult patients admitted to the emergency department, presenting with an ankle sprain |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of patients admitted to adult emergency departments with ankle sprains.
Key inclusion criteria (5 listed)
- Patient over 18 years of age
- Presenting an isolated ankle sprain
- Visiting Nantes CHU emergency department for this reason
- Patient able to read and speak French
- Patient covered by a social security scheme
Key exclusion criteria (5 listed)
- Patient > 70 years old
- Patients requiring hospitalization following a visit to the emergency department
- Any intercurrent pathology that may affect the management of the ankle sprain
- Associated ankle fracture
- Patients under legal protection.
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 |
|---|---|---|
| QuestionnaireAlso: Phone callAn initial questionnaire is completed on D0, the day of the patient's admission to the emergency department, by the practitioner in charge of the patient, and covers the patient's anamnesis, clinical examination, radiological examinations and treatment. A follow-up telephone visit is then carried out at 30 days by an investigator, to gather information on the clinical and therapeutic evolution, and to evaluate the recovery and evolution of symptoms experienced by the patient in relation to the initial management. | Other | Study population |
Primary outcome
To evaluate the recovery experienced by patients with ankle sprains treated in the adult emergency department of Nantes University Hospital.
Time frame: 30 days
Percentage of patients feeling fully cured at D30
8 secondary outcomes
Compare healing sensation with different types of immobilization
Time frame: 30 days
Compare healing sensation with duration of immobilization
Time frame: 30 days
Compare the feeling of healing with the initial analgesic proposed
Time frame: 30 days
Comparing the feeling of recovery according to whether or not a state-certified physiotherapist was involved in the treatment
Time frame: 30 days
Compare the feeling of recovery according to the presence or absence of early medical reassessment
Time frame: 30 days
Identify discharge prescription patterns of patients admitted for ankle sprains
Time frame: 30 days
Identify patients who finally received an alternative diagnosis
Time frame: 30 days
Assessing patients' quality of life at D30 after an ankle sprain
Time frame: 30 days
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 12 Jun 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Ankle Sprains
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The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training in Amateur Athletes With Chronic Ankle Instability
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The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training in Chronic Ankle Instability
Ankle Sprains, Ankle Sprain Strain
Not yet recruiting
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Chronic Ankle Instability, Ankle Sprain
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 Sprains, run by Nantes University Hospital 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 5 inclusion and 5 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 12 Jun 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?
To evaluate the recovery experienced by patients with ankle sprains treated in the adult emergency department of Nantes University Hospital. (time frame: 30 days). 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 12 Jun 2025.