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Not yet recruitingNCT07917273ASGOUpdated Nov 4, 2026

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.

An interventional study of Ankle-GO test and questionnaires in Ankle Sprain, sponsored by Groupe Hospitalier de la Rochelle Ré Aunis. Not yet recruiting at 1 site in France. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-11-04.

Sponsored by Groupe Hospitalier de la Rochelle Ré Aunis · Not applicable, Interventional, and Other

Updated Nov 4, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
76
Allocation
Not applicable
Ages
18 Years to 50 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Ankle Sprain

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Keywords

  • Lateral ankle sprain
  • Ankle-GO score
  • Functional recovery
  • Early rehabilitation
  • Return to sport
03

In context

Ankle Injuries

350 studies on the registry are indexed under Ankle Injuries; 74 are open to participants now.

This study's planned enrollment of 76 is above the median of 54 across 270 interventional studies indexed under Ankle Injuries.

Browse Ankle Injuries studies →

Lead sponsor

Groupe Hospitalier de la Rochelle Ré Aunis is the lead sponsor of 22 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. . 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
  2. . 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
  3. . 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

Exclusion criteria

Exclusion Criteria:

  1. . Criteria related to the study population

    - Patients under 18 years of age or over 50 years of age

  2. . 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
    • 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
  3. . Criteria related to medical history

    - History of surgery or fracture involving the affected ankle

  4. . 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
  5. . Criteria related to follow-up

    • Anticipated inability to complete the follow-up assessments planned in the study protocol
    • Refusal to participate in the study
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
76 participants (estimated)

Study arms

  • Experimental
    Experimental group

    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.

    Procedure: Ankle-GO test and questionnaires

Interventions

  • ProcedureAnkle-GO test and questionnaires

    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.

06

What researchers measure

Primary outcomes

  1. Total Ankle-GO score measured at M2

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

    Time frame: 2 months

Secondary outcomes

  1. Ankle-GO score measured at M1

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

    Time frame: 1 month

  2. Ankle-GO score measured at M4

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

    Time frame: 4 months

  3. Return to sport at M2

    Actual return to sport assessed at month 2 (M2)

    Time frame: 2 months

  4. Return to sport at M4

    Actual return to sport assessed at month 4 (M4)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 4 months

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: 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

Supporting information: Study protocol

Time frame: Data will be available immediately following publication

Access criteria: Researchers who provide a methodologically sound proposal will have access to the data

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for Sep 2027, 10 months later.

Of 138 non-industry interventional studies with no phase under Ankle Injuries, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 30. This study's planned 10 months is above that.

Counting every sponsor, half of 141 studies reached it within 9 months; a quarter within 4 and three quarters within 31.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 29, 2026
First posted
Nov 4, 2026
StartEst.
Nov 2026
Primary completionEst.
Sep 2027
CompletionEst.
Nov 2027
Last update
Nov 4, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 4, 2026
Show all 1 update
  1. Nov 4, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07917273
Lead sponsor
Groupe Hospitalier de la Rochelle Ré Aunis
Responsible party
Sponsor
First posted
Nov 4, 2026
Start date
Nov 2026 (estimated)
Primary completion
Sep 2027 (estimated)
Completion
Nov 2027 (estimated)
Last update
Nov 4, 2026

Study contacts

Cécile Duchiron, Project Manager
Contact
cecile.duchiron@ght-atlantique17.fr
05 46 68 45 67 ext. +33
Corentin Boulay Le Soleuz, Resident physician
study director · Groupe Hospitalier de la Rochelle Ré Aunis

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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