- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06657937
Evaluation of the Recovery Experienced by Patients After an Ankle Sprain Treated in the Emergency Department of Nantes University Hospital (ANKHEAL)
ANKHEAL - Evaluation of the Recovery Experienced by Patients After an Ankle Sprain Treated in the Emergency Department of Nantes University Hospital
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Loire-Atlantique
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Nantes, Loire-Atlantique, France, 44000
- Nantes University Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Study population
The study population must correspond to the research inclusion criteria: Adult patients admitted to the emergency department, presenting with an ankle sprain |
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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
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30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Compare healing sensation with different types of immobilization
Time Frame: 30 days
|
Rate of patients feeling fully healed at D30 according to type of immobilization
|
30 days
|
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Compare healing sensation with duration of immobilization
Time Frame: 30 days
|
Rate of patients feeling fully healed at D30 according to length of immobilization
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30 days
|
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Compare the feeling of healing with the initial analgesic proposed
Time Frame: 30 days
|
Rate of patients feeling fully healed at D30 according to initial analgesia proposed
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30 days
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Comparing the feeling of recovery according to whether or not a state-certified physiotherapist was involved in the treatment
Time Frame: 30 days
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Rate of patients feeling fully healed at D30 according to whether or not they were treated by a state-qualified physiotherapist
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30 days
|
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Compare the feeling of recovery according to the presence or absence of early medical reassessment
Time Frame: 30 days
|
Rate of patients feeling fully cured at D30 according to the presence or absence of an early medical reassessment
|
30 days
|
|
Identify discharge prescription patterns of patients admitted for ankle sprains
Time Frame: 30 days
|
Prescription rates for each of the immobilization, analgesia and remote consultation modalities
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30 days
|
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Identify patients who finally received an alternative diagnosis
Time Frame: 30 days
|
Rate of patients receiving an alternative diagnosis
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30 days
|
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Assessing patients' quality of life at D30 after an ankle sprain
Time Frame: 30 days
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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).
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30 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- RC24_0524
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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