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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)

29 ottobre 2026 aggiornato da: Groupe Hospitalier de la Rochelle Ré Aunis

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.

Panoramica dello studio

Stato

Non ancora reclutamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

76

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 50 anni (Adulto)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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:

  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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Altro
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.

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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Total Ankle-GO score measured at M2
Lasso di tempo: 2 months

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

2 months

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Ankle-GO score measured at M1
Lasso di tempo: 1 month

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

1 month
Ankle-GO score measured at M4
Lasso di tempo: 4 months

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

4 months
Return to sport at M2
Lasso di tempo: 2 months

Actual return to sport assessed at month 2 (M2)

2 months
Return to sport at M4
Lasso di tempo: 4 months

Actual return to sport assessed at month 4 (M4)

4 months
Time to return to sport at M2
Lasso di tempo: 2 months

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)

2 months
Time to return to sport at M4
Lasso di tempo: 4 months

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)

4 months
Level of return to sport at M2
Lasso di tempo: 2 months

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

2 months
Level of return to sport at M4
Lasso di tempo: 4 months

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

4 months
Occurrence of a recurrent lateral ankle sprain
Lasso di tempo: 4 months

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

4 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Direttore dello studio: Corentin Boulay Le Soleuz, Resident physician, Groupe Hospitalier de la Rochelle Ré Aunis

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 novembre 2026

Completamento primario (Stimato)

1 settembre 2027

Completamento dello studio (Stimato)

1 novembre 2027

Date di iscrizione allo studio

Primo inviato

29 ottobre 2026

Primo inviato che soddisfa i criteri di controllo qualità

29 ottobre 2026

Primo Inserito (Effettivo)

4 novembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

4 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

29 ottobre 2026

Ultimo verificato

1 ottobre 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

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

Periodo di condivisione IPD

Data will be available immediately following publication

Criteri di accesso alla condivisione IPD

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

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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