- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07659561
Assessment of Electromyographic Activity in the Quadriceps and Hamstrings of the Operated Limb Versus the Unaffected Limb in Patients Who Have Undergone ACL Surgery, With and Without Post-operative AMI - an Exploratory Study (AMIMYO)
Traumatic injuries to the knee joint, such as an anterior cruciate ligament tear, can compromise the ability of the muscle at the front of your thigh-known as the quadriceps-to contract voluntarily, despite the anatomical integrity of the nerve and muscle structures responsible for contraction. This phenomenon, commonly known as 'arthrogenic motor inhibition' (AMI), is a major limiting factor for recovery and rehabilitation following an anterior cruciate ligament tear, as well as a potential cause of functional disability if left undiagnosed and untreated. Indeed, motor inhibition that persists during the early months of rehabilitation could lead to under-activation of the quadriceps and over-activation of the hamstrings (the muscles at the back of your thigh).
It is of interest to assess, during the rehabilitation phase, the contraction capacity of the various quadriceps and hamstring muscles in the operated limb compared with the unaffected limb in patients who have undergone anterior cruciate ligament surgery and who experience post-operative motor inhibition, and in patients who have undergone anterior cruciate ligament surgery but do not experience post-operative motor inhibition. This is why this study has been initiated.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
An ACL tear and reconstruction can lead to a neurophysiological dysfunction commonly known as 'arthrogenic muscle inhibition' (AMI). This phenomenon impairs the ability to voluntarily activate the quadriceps, despite the anatomical integrity of the nerve and muscle structures responsible for contraction.
AMI is responsible for the quadriceps deficits observed following an ACL rupture and thus appears to be a major limiting factor in the patient's rehabilitation and functional recovery. Consequently, its diagnosis and treatment are imperative. The diagnosis of AMI (post-rupture and post-operative) is based on a classification system that categorises AMI diagnoses according to the identification of a deficit in activation of the vastus medialis (VM) alone (grade 1) or in combination with an extension deficit due to a grade 2 hamstring contracture (grade 2) (Sonnery-Cottet et al, 2022).
During the clinical examination, normal VM contraction (during relaxation) can be achieved without the recruitment of all motor units (minimal VM activation), and full knee extension (i.e. without reflex contraction of the hamstrings) can be restored without a return to adequate hamstring activation for the required task. Deficits in activation (inadequate activation) of the quadriceps and over-activation of the hamstrings (Hamstrings) during movements involving greater forces could be the consequences of an AMI still present in the early months of rehabilitation. This AMI could then disrupt the electromyographic (EMG) activation patterns of the quadriceps and hamstrings and contribute to long-term quadriceps deficits.
In this context, it is of interest to assess, during the rehabilitation phase, the EMG activity of the different muscle heads of the quadriceps and hamstrings in the operated limb versus the healthy limb in patients who have undergone ACL surgery and experienced post-operative IMA, and in patients who have undergone ACL surgery without post-operative IMA.
No studies have been published on this topic. This is why this research has been initiated.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Bertrand SONNERY-COTTET, MD
- Número de teléfono: + 33 4 37 53 00 22
- Correo electrónico: sonnerycottet@aol.com
Ubicaciones de estudio
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Lyon, Francia, 69008
- Hôpital privé Jean Mermoz
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Contacto:
- Bertrand SONNERY-COTTET, MD
- Número de teléfono: + 33 4 37 53 00 22
- Correo electrónico: sonnerycottet@aol.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Patient who has undergone ACL surgery at least 3 weeks ago
- Patient with no severe knee inflammation: stroke test ≤ 1+ and pain ≤ 3/10 (EN) at rest
- Patient with a Tegner score ≥ 5
- Patient with a Marx score ≥ 8
- Patient with or without a diagnosis of subjective AMI (Sonnery-Cottet et al. classification)
- French-speaking patients who do not object to the use of their data
Exclusion Criteria:
- Patient with a previous injury or surgery to the same or opposite knee
- Patient with a multi-ligament injury
- Patient with an AMI > grade 2b (Sonnery-Cottet et al. classification)
- Patient with a BMI > 30
- Pregnant or breastfeeding woman
- Patient with previous or current neurological and cardiovascular disorders or diseases
- Patient under legal protection: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: ACL Arm
Patient with ACL rupture
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Surface EMG of the quadriceps (vastus medialis, vastus lateralis and vastus longus) and the semimembranosus and biceps femoris muscles of the hamstrings on both the affected and unaffected sides, to objectively assess quadriceps inhibition.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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EMG activity
Periodo de tiempo: Month 3
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The average amplitude of EMG activity in the VM (Vastus Medialis) is assessed using the Root Mean Square (RMS) value, which is expressed in millivolts (mV).
The RMS is recorded using surface electrodes placed on the vastus medialis.
The primary outcome measure (activation deficit) is the absolute difference in RMS between the operated leg and the unaffected leg.
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Month 3
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Colaboradores e Investigadores
Patrocinador
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 rodilla
- Lesiones del ligamento cruzado anterior
- Terapéutica
- Terapias de la mente-cuerpo
- Terapias complementarias
- Terapia conductual
- Psicoterapia
- Disciplinas y actividades de comportamiento
- Biofeedback, psicología
- Comentarios, psicológico
- Neurofeedback
Otros números de identificación del estudio
- 2026-A00008-43
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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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