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.
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.
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
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 group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Participants 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.
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)
Ankle-GO score measured at M1
Ankle-GO score measured at month 1 (M1) after the lateral ankle sprain.
Measured: 1 month
Ankle-GO score measured at M4
Ankle-GO score measured at month 4 (M4) after the lateral ankle sprain.
Measured: 4 months
Return to sport at M2
Actual return to sport assessed at month 2 (M2)
Measured: 2 months
Return to sport at M4
Actual return to sport assessed at month 4 (M4)
Measured: 4 months
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
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
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
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
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.
- First posted4 Nov 2026
- Study startNov 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle SprainStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier de la Rochelle Ré Aunis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Corentin Boulay Le Soleuz, Resident physician, Study director, Groupe Hospitalier de la Rochelle Ré Aunis
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
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07917273
- Acronym / sponsor ID
- ASGO / P04051
- Conditions
- Ankle Sprain
- Keywords
- Lateral ankle sprain, Ankle-GO score, Functional recovery, Early rehabilitation, Return to sport
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Groupe Hospitalier de la Rochelle Ré AunisUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 4 Nov 2026 (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 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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Procedure: Ankle-GO test and questionnairesParticipants 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- . Criteria related to the study population
- . Criteria related to the condition under study
- . Criteria related to sports participation
Key exclusion criteria (19 listed)
- . Criteria related to the study population
- . Criteria related to the condition under study
- . Criteria related to medical history
- . Criteria related to associated conditions
- . Criteria related to follow-up
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 |
|---|---|---|
| Ankle-GO test and questionnairesAfter 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. | Procedure or surgery | Experimental group |
Primary outcome
Total Ankle-GO score measured at M2
Time frame: 2 months
Total Ankle-GO score measured two months (M2) after the lateral ankle sprain
9 secondary outcomes
Ankle-GO score measured at M1
Time frame: 1 month
Ankle-GO score measured at M4
Time frame: 4 months
Return to sport at M2
Time frame: 2 months
Return to sport at M4
Time frame: 4 months
Time to return to sport at M2
Time frame: 2 months
Time to return to sport at M4
Time frame: 4 months
Level of return to sport at M2
Time frame: 2 months
Level of return to sport at M4
Time frame: 4 months
Occurrence of a recurrent lateral ankle sprain
Time frame: 4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: 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
Related trials for Ankle Sprain
Recruiting
Enovis High Ankle Sprain Brace Testing
Athletes in Cutting Sports
Recruiting
The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training in Amateur Athletes With Chronic Ankle Instability
Ankle Sprain, Ankle Sprain Strain
Recruiting
The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training in Chronic Ankle Instability
Ankle Sprains, Ankle Sprain Strain
Not yet recruiting
Collagen Scaffold Bioaugmentation for ATFL Repair in Chronic Ankle Instability
Chronic Ankle Instability, Ankle Sprain
Recruiting
Comparison of the Effects of Hip and Ankle Focused Progressive Exercise Training on Lower Extremity Function in Athletes With Chronic Ankle Instability
Ankle Sprains
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.
Corentin Boulay Le Soleuz, Resident physician study director
Groupe Hospitalier de la Rochelle Ré Aunis
1 site in 1 country: see every site and its status.
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.