AzTrials
AzTrials

Ankle SprainASGONCT07917273

Functional Recovery After a Recent Lateral Ankle Sprain With Early Initiation of Rehabilitation: Changes in the Ankle-GO Score and Its Association With Return to Sport and Recurrent Sprains.

A study testing Ankle-GO test and questionnaires in people with Ankle Sprain, run by Groupe Hospitalier de la Rochelle Ré Aunis at 1 site in France.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

Lateral ankle sprains are common musculoskeletal injuries, particularly among young adults and athletes. Although recovery is often favorable, lateral ankle sprains may be associated with persistent pain, chronic ankle instability, delayed return to sport, and an increased risk of recurrence. Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
Ankle Sprain
What is being tested?
Ankle-GO test and questionnaires
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
76 participants
Where
1 siteFrance
Study dates
Nov 2026to Nov 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • . Criteria related to the study population
  • Male or female aged 18 to 50 years, inclusive
  • Affiliated with a social security system
  • Sufficient understanding of French to understand the information sheet and complete the questionnaires
  • Free, informed, and signed consent provided by the participant and the investigator (no later than the day of enrollment and before any examination required for the clinical research), following oral and written information
  • Ability to complete all follow-up assessments planned in the study protocol
Show all 13Show fewer
  • . Criteria related to the condition under study
  • Recent lateral ankle sprain clinically diagnosed by a physician
  • Sprain occurring within the 7 days preceding enrollment
  • Initial management provided at one of the participating centers
  • . Criteria related to sports participation
  • Regular participation in a sporting activity before the injury, defined as at least one session per week during the three months preceding the sprain
  • Willingness to return to sport

Who cannot join

  • . Criteria related to the study population
  • Patients under 18 years of age or over 50 years of age
  • . Criteria related to the condition under study
  • Clinically or radiologically confirmed associated fracture
  • Ankle sprain requiring prolonged strict immobilization
  • Suspected or diagnosed severe syndesmotic injury requiring specific management
Show all 19Show fewer
  • Suspected or diagnosed Chopart or Lisfranc injury
  • Initial indication for surgery
  • Sprain of the same ankle within the six months preceding enrollment
  • Known chronic ankle instability
  • . Criteria related to medical history
  • History of surgery or fracture involving the affected ankle
  • . Criteria related to associated conditions
  • Neurological disorder likely to impair balance or motor control
  • Known condition affecting balance
  • Concomitant musculoskeletal injury of the lower limb likely to limit performance of functional tests
  • . Criteria related to follow-up
  • Anticipated inability to complete the follow-up assessments planned in the study protocol
  • Refusal to participate in the study

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Cécile Duchiron, Project Manager contact

05 46 68 45 67 ext. +33

cecile.duchiron@ght-atlantique17.fr

France1 site
  • Groupe Hospitalier de La Rochelle Ré Aunis

    La Rochelle, 17000

    Cécile Duchiron, Project Manager, 05 46 68 45 67 ext. +33, cecile.duchiron@ght-atlantique17.fr

Other trials in France

About this study

Official title: Functional Recovery After a Recent Lateral Ankle Sprain With Early Initiation of Rehabilitation: Changes in the Ankle-GO Score and Its Association With Return to Sport and Recurrent Sprains: ASGO Study

Lateral ankle sprains are common musculoskeletal injuries, particularly among young adults and athletes. Although recovery is often favorable, lateral ankle sprains may be associated with persistent pain, chronic ankle instability, delayed return to sport, and an increased risk of recurrence. The Ankle-GO score is a recently developed tool for assessing functional recovery after a lateral ankle sprain. Available data mainly concern assessments performed from the second month after injury onward. To our knowledge, changes in this score during the early recovery phase have not yet been evaluated. The ASGO study aims to describe changes in the Ankle-GO score in patients enrolled early after a lateral ankle sprain and followed for four months.

Read the detailed description

Lateral ankle sprains are among the most common musculoskeletal injuries in young adults and athletes. Although often considered minor injuries, they can result in substantial morbidity, including persistent pain, functional limitations, reduced physical activity levels, and frequent recurrences.

The literature indicates that a substantial proportion of patients experience persistent symptoms after an initial lateral ankle sprain, and approximately 20% to 40% develop chronic ankle instability. Return to sport after an ankle sprain remains insufficiently standardized and is still frequently based on time-based or subjective criteria, despite the recent emergence of international recommendations based on clinical, functional, and psychological criteria.

Current recommendations favor early functional management, including limiting immobilization, progressively resuming weight-bearing, implementing an appropriate rehabilitation program, and applying the principles of the PEACE \& LOVE protocol. Despite these recommendations, management practices remain heterogeneous in primary care and emergency departments.

To improve the assessment of functional recovery after a lateral ankle sprain, researchers have developed and subsequently validated the Ankle-GO score. This tool combines several functional tests and validated questionnaires to assess the physical and psychological dimensions of recovery, as well as readiness to return to sport.

Studies have shown that a low Ankle-GO score measured two months after a lateral ankle sprain is associated with delayed return to sport, an increased risk of recurrence, and a lower likelihood of complete functional recovery. These studies primarily assessed patients from the second month after injury onward.

To the investigator's knowledge, no study has specifically described changes in the Ankle-GO score in patients enrolled within the first few days after a sprain or investigated the potential value of assessment during the first month of follow-up.

Furthermore, several studies suggest that delayed initiation of rehabilitation may be associated with an increased risk of recurrence and less favorable functional recovery. To investigate this early recovery phase and document the actual time to rehabilitation initiation, only patients enrolled within seven days of injury will be included.

The ASGO study builds on the work of a reseracher by investigating a population enrolled within seven days of injury, a period during which early initiation of rehabilitation may influence functional recovery and the risk of recurrence.

The investigator's hypothesis is that early management following a lateral ankle sprain, combined with early initiation of functional rehabilitation after injury, is associated with better functional recovery, as assessed by the Ankle-GO score at two months.

Investigator also hypothesize that a higher Ankle-GO score at one month may be associated with a faster return to sport and a lower risk of recurrence during follow-up. This hypothesis is based on the findings of a researcher, who showed that a higher Ankle-GO score at two months was associated with better return-to-sport outcomes and a reduced risk of recurrence following a lateral ankle sprain.

Conditions
Ankle Sprain
Being tested
Ankle-GO test and questionnaires
Keywords
Lateral ankle sprain, Ankle-GO score, Functional recovery, Early rehabilitation, Return to sport
Medical subject headings
Ankle Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ankle-GO test and questionnairesProcedure or surgery

    After enrollment, a telephone call will be conducted on day 10, followed by follow-up visits (Ankle-GO test and questionnaires) at months 1, 2, and 4.

Study groups in NCT07917273
Study groupRoleWhat they receive
Experimental groupExperimentalParticipants will be enrolled within seven days of a recent lateral ankle sprain and followed for four months, with a telephone call on day 10 and follow-up visits (Ankle-GO test and questionnaires) at months 1, 2, and 4.
Receives: Procedure: Ankle-GO test and questionnaires

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total Ankle-GO score measured at M2

    Total Ankle-GO score measured two months (M2) after the lateral ankle sprain

    Measured: 2 months

Secondary outcomes (9)
  1. Ankle-GO score measured at M1

    Ankle-GO score measured at month 1 (M1) after the lateral ankle sprain.

    Measured: 1 month

  2. Ankle-GO score measured at M4

    Ankle-GO score measured at month 4 (M4) after the lateral ankle sprain.

    Measured: 4 months

  3. Return to sport at M2

    Actual return to sport assessed at month 2 (M2)

    Measured: 2 months

  4. Return to sport at M4

    Actual return to sport assessed at month 4 (M4)

    Measured: 4 months

  5. Time to return to sport at M2

    Time to return to sport, expressed as the number of days between the date of injury and the first return to sport measured at month 2 (M2)

    Measured: 2 months

  6. Time to return to sport at M4

    Time to return to sport, expressed as the number of days between the date of injury and the first return to sport measured at month 4 (M4)

    Measured: 4 months

  7. Level of return to sport at M2

    Level of return to sport, compared with the self-reported pre-injury sports level (same or lower level) measured at month 2 (M2)

    Measured: 2 months

  8. Level of return to sport at M4

    Level of return to sport, compared with the self-reported pre-injury sports level (same or lower level) measured at month 4 (M4)

    Measured: 4 months

  9. Occurrence of a recurrent lateral ankle sprain

    Occurrence of a recurrent lateral ankle sprain affecting the initially injured ankle between enrollment (day 0) and the end of follow-up (month 4)

    Measured: 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 2026
  2. Study startNov 2026 (estimated)
  3. Primary completionSep 2027 (estimated)
  4. Study completionNov 2027 (estimated)

Resources

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
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
76 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07917273
Sponsor's protocol ID
P04051
Other IDs
2026-A01644-47
Acronym
ASGO
Status last verified
Oct 2026
First submitted
29 Oct 2026
Last updated
4 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data will be made available with publication. A Digital Object Identifier will be used and Data will be available at www.recherche.data.gouv.fr

Questions about this trial

What is this clinical trial studying?

A study testing Ankle-GO test and questionnaires in people with Ankle Sprain, run by Groupe Hospitalier de la Rochelle Ré Aunis 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 13 inclusion and 19 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: opening soon, as of the sponsor's last update on 4 Nov 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Cécile Duchiron, Project Manager (05 46 68 45 67 ext. +33, cecile.duchiron@ght-atlantique17.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total Ankle-GO score measured at M2 (time frame: 2 months). 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 4 Nov 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in