- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07917273
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)
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Cécile Duchiron, Project Manager
- Número de teléfono: +33 05 46 68 45 67
- Correo electrónico: cecile.duchiron@ght-atlantique17.fr
Ubicaciones de estudio
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La Rochelle, Francia, 17000
- Groupe Hospitalier de La Rochelle Ré Aunis
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Contacto:
- Cécile Duchiron, Project Manager
- Número de teléfono: +33 05 46 68 45 67
- Correo electrónico: cecile.duchiron@ght-atlantique17.fr
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
-
. 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
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. 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
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. 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:
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. Criteria related to the study population
- Patients under 18 years of age or over 50 years of age
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. 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
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. Criteria related to medical history
- History of surgery or fracture involving the affected ankle
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. 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
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. Criteria related to follow-up
- Anticipated inability to complete the follow-up assessments planned in the study protocol
- Refusal to participate in the study
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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. |
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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Total Ankle-GO score measured at M2
Periodo de tiempo: 2 months
|
Total Ankle-GO score measured two months (M2) after the lateral ankle sprain |
2 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Ankle-GO score measured at M1
Periodo de tiempo: 1 month
|
Ankle-GO score measured at month 1 (M1) after the lateral ankle sprain. |
1 month
|
|
Ankle-GO score measured at M4
Periodo de tiempo: 4 months
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Ankle-GO score measured at month 4 (M4) after the lateral ankle sprain. |
4 months
|
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Return to sport at M2
Periodo de tiempo: 2 months
|
Actual return to sport assessed at month 2 (M2) |
2 months
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Return to sport at M4
Periodo de tiempo: 4 months
|
Actual return to sport assessed at month 4 (M4) |
4 months
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Time to return to sport at M2
Periodo de tiempo: 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
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|
Time to return to sport at M4
Periodo de tiempo: 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
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|
Level of return to sport at M2
Periodo de tiempo: 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
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|
Level of return to sport at M4
Periodo de tiempo: 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
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Occurrence of a recurrent lateral ankle sprain
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Corentin Boulay Le Soleuz, Resident physician, Groupe Hospitalier de la Rochelle Ré Aunis
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Heridas y Lesiones
- Lesiones en las piernas
- Lesiones de tobillo
- Calidad, acceso y evaluación de la atención médica
- Técnicas de investigación
- Métodos epidemiológicos
- Recopilación de datos
- Mecanismos de evaluación de atención médica
- Calidad de la atención médica
- Salud pública
- Medio ambiente y salud pública
- Encuestas y cuestionarios
Otros números de identificación del estudio
- P04051
- 2026-A01644-47 (Otro identificador: ANSM)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan 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
Marco de tiempo para compartir IPD
Data will be available immediately following publication
Criterios de acceso compartido de IPD
Researchers who provide a methodologically sound proposal will have access to the data
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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