- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07674784
Interventions to Enhance Quadriceps Output After ACLR
Clinical Interventions to Acutely Enhance Quadriceps Output After Anterior Cruciate Ligament Reconstruction
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
After a screening visit, participants will be randomized to 2 intervention conditions over 2, 60-minute visits at least 1 week apart where they will complete:
- a 5 minute low intensity warm-up on a stationary bike
- a series of patient-reported outcomes surveys
- a pre-intervention quadriceps performance assessment
the intervention condition, one each visit, either:
- ~20 minutes of NMES while completing rehabilitation exercises, OR
- ~20 minutes of hamstring muscle vibration
- a post-intervention quadriceps performance assessment
The primary objective of the study is to characterize the acute effects of interventions designed to mitigate the influence of inhibition (NMES and hamstrings muscle vibration) on quadriceps muscle performance in people post-anterior cruciate ligament reconstruction (ACLR) who have significant potential to benefit from these interventions (e.g. less than 4 months post-surgery).
- Specific Aim 1: To determine the acute effects of quadriceps NMES and hamstrings muscle vibration on quadriceps muscle performance in people 2-4 months post-ACLR
- Specific Aim 2: To determine if individuals with signs of more pronounced neural inhibition (quantified via assessment of knee extensor torque steadiness) have greater responses to NMES and hamstrings muscle vibration
Hypothesis 1: Quadriceps muscle strength will increase in people 2-4 months post-ACLR after 20 minutes of quadriceps NMES or hamstrings muscle vibration. The magnitude of increase in strength will be similar for both interventions.
Hypothesis 2: Surgical limb knee extensor torque steadiness will be strongly positively correlated with changes in quadriceps strength after NMES or hamstrings muscle vibration. People with greater steadiness impairments will demonstrate greater acute increases in quadriceps strength.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Daniel Cobian, DPT, PhD
- Número de teléfono: 608-262-0013
- Correo electrónico: cobian@ortho.wisc.edu
Ubicaciones de estudio
-
-
Wisconsin
-
Madison, Wisconsin, Estados Unidos, 53706
- Reclutamiento
- UW Health
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Have undergone ACLR within the previous 4 months
- Are at least 2 months post-ACLR
Exclusion Criteria:
- A history of ACLR on both legs
Since the most recent ACLR:
- secondary lower extremity surgery
- leg or foot fracture
- Unable to walk without an assistive device
- Pain of greater than 5/10 during quadriceps strengthening exercises with the surgical limb
- Cannot achieve 90 degrees of knee flexion with the surgical limb
- People with contraindications to NMES
- Anyone who had a previous skin reaction to NMES or attempted but could not tolerate NMES
- Peripheral neuropathy or other neurological conditions
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: NMES then Vibration
|
The thigh of the surgical leg will be cleaned with isopropyl alcohol.
2.75" x 5" NMES electrodes (Dura-Stick Plus, Chattanooga, DJO Global, Dallas, TX) will be adhered to the proximal and distal aspects of the quadriceps muscles.
An FDA-approved portable neuromuscular electrical stimulator (Empi Continuum, DJO Global, Dallas, TX) will be utilized to deliver a biphasic square wave pulse (frequency 75 Hz, pulse width 300 µs) to the quadriceps of the surgical limb.
Participants will control both the amplitude of current delivered (0-100 mA) and the on/off timing of the stimulation via a wired control switch.
Participants will complete common post-ACLR rehabilitation exercises while NMES is delivered (total time for exercises is approximately 20 minutes).
Otros nombres:
Participants will sit in a comfortable position on a treatment plinth with knees flexed to ~30°, hips flexed between 30-60°, and the back supported.
The back of the thighs will rest on the vibration pads of a commercial vibration device (Thumper Versa Pro Massager, (Thumper Massager Inc., Markham, Ontario, CA).
Participants will sit at rest for 20 minutes while the vibration device provides a 30 Hz vibration with an amplitude of ~6 mm.
Otros nombres:
|
|
Experimental: Vibration then NMES
|
The thigh of the surgical leg will be cleaned with isopropyl alcohol.
2.75" x 5" NMES electrodes (Dura-Stick Plus, Chattanooga, DJO Global, Dallas, TX) will be adhered to the proximal and distal aspects of the quadriceps muscles.
An FDA-approved portable neuromuscular electrical stimulator (Empi Continuum, DJO Global, Dallas, TX) will be utilized to deliver a biphasic square wave pulse (frequency 75 Hz, pulse width 300 µs) to the quadriceps of the surgical limb.
Participants will control both the amplitude of current delivered (0-100 mA) and the on/off timing of the stimulation via a wired control switch.
Participants will complete common post-ACLR rehabilitation exercises while NMES is delivered (total time for exercises is approximately 20 minutes).
Otros nombres:
Participants will sit in a comfortable position on a treatment plinth with knees flexed to ~30°, hips flexed between 30-60°, and the back supported.
The back of the thighs will rest on the vibration pads of a commercial vibration device (Thumper Versa Pro Massager, (Thumper Massager Inc., Markham, Ontario, CA).
Participants will sit at rest for 20 minutes while the vibration device provides a 30 Hz vibration with an amplitude of ~6 mm.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Change in knee extensor peak torque production
Periodo de tiempo: measured pre-intervention and post-intervention during each of 2, 1-hour study visits, data collection complete within 3 weeks
|
measured pre-intervention and post-intervention during each of 2, 1-hour study visits, data collection complete within 3 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Change in knee extensor torque steadiness
Periodo de tiempo: measured pre-intervention and post-intervention during each of 2, 1-hour study visits, data collection complete within 3 weeks
|
measured pre-intervention and post-intervention during each of 2, 1-hour study visits, data collection complete within 3 weeks
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Daniel Cobian, DPT, PhD, University of Wisconsin, Madison
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
Otros números de identificación del estudio
- 2026-0153
- Protocol Version 10/24/25 (Otro identificador: UW Madison)
- SMPH | Ortho and Rehab (Otro identificador: UW Madison)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
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Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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