NCT07054892

Brief 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. 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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
176

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2025

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 8, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

July 11, 2025

Status Verified

July 1, 2025

Enrollment Period

3 months

First QC Date

June 27, 2025

Last Update Submit

July 10, 2025

Conditions

Keywords

ankle injuriesemergency departmentpatient follow-up

Outcome Measures

Primary Outcomes (1)

  • 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).

    At inclusion in the study and 3 months later

Study Arms (1)

Participants with ankle sprain

Participants presenting to the emergency department of Saint-Brieuc for an ankle sprain

Behavioral: FAAM - Activities of Daily Living (ADL) Subscale

Interventions

The FAAM score is scientifically validated and allows for the assessment of foot and ankle functional ability

Participants with ankle sprain

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants presenting to the emergency department of Saint-Brieuc for an ankle sprain.

You may qualify if:

  • Age ≥ 18 years
  • Ankle trauma
  • Initial consultation at the emergency department of Saint-Brieuc

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier de Saint-Brieuc - Paimpol - Tréguier

Saint-Brieuc, 22000, France

RECRUITING

MeSH Terms

Conditions

Ankle InjuriesEmergencies

Interventions

Activities of Daily Living

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and InjuriesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2025

First Posted

July 8, 2025

Study Start

April 1, 2025

Primary Completion

July 1, 2025

Study Completion

October 1, 2025

Last Updated

July 11, 2025

Record last verified: 2025-07

Locations