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
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.
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.
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 →Groupe Hospitalier de la Rochelle Ré Aunis is the lead sponsor of 22 studies on the registry; 6 are open to participants now.
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. Criteria related to the study population
. Criteria related to the condition under study
. Criteria related to sports participation
Exclusion Criteria:
. 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
. Criteria related to medical history
- History of surgery or fracture involving the affected ankle
. Criteria related to associated conditions
. Criteria related to follow-up
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
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.
Total Ankle-GO score measured at M2
Total Ankle-GO score measured two months (M2) after the lateral ankle sprain
Time frame: 2 months
Ankle-GO score measured at M1
Ankle-GO score measured at month 1 (M1) after the lateral ankle sprain.
Time frame: 1 month
Ankle-GO score measured at M4
Ankle-GO score measured at month 4 (M4) after the lateral ankle sprain.
Time frame: 4 months
Return to sport at M2
Actual return to sport assessed at month 2 (M2)
Time frame: 2 months
Return to sport at M4
Actual return to sport assessed at month 4 (M4)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 4 months
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.
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.
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 ↗
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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Groupe Hospitalier de la Rochelle Ré Aunis