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Stair Biomechanics and Vibration Study After ACLR

2 de noviembre de 2026 actualizado por: University of North Carolina, Chapel Hill

Lower Extremity Biomechanics During Gait and Stair Negotiation and Effects of Vibratory Stimuli Following ACL Reconstruction

This study examines how people who have had anterior cruciate ligament reconstruction (ACLR) move their legs during walking and stair negotiation, and whether a single session of vibration changes how they ascend and descend stairs.

Participants with ACLR (1 to 3 years after surgery) complete three laboratory visits. At the first visit, they complete walking, stair negotiation, muscle strength, hopping tests, and questionnaires, and stair negotiation is measured before and after a control condition without vibration. At the second and third visits, they receive whole-body vibration (standing on a vibrating platform) or local muscle vibration (a device placed over the thigh muscle) in a counterbalanced order, and stair negotiation is measured before and after each vibration session. Healthy participants matched by sex, age, and activity level complete one visit with the same tests as the first ACLR visit, for comparison.

Descripción general del estudio

Descripción detallada

Individuals with ACLR commonly show altered lower extremity biomechanics and quadriceps dysfunction that may contribute to the development of knee osteoarthritis. Stair negotiation places greater demands on the knee than level walking, yet findings on stair biomechanics after ACLR are inconsistent. Whole-body vibration (WBV) and local muscle vibration (LMV) acutely improve quadriceps function and gait biomechanics after ACLR, but their effects on stair biomechanics are unknown.

Aims: 1. to compare lower extremity biomechanics during gait, stair ascent, and stair descent between individuals 1 to 3 years after ACLR and matched healthy controls; 2. to determine inter-limb differences in biomechanics during gait and stair negotiation within individuals with ACLR; 3. to evaluate the acute effects of WBV and LMV on stair ascent and descent biomechanics in individuals with ACLR compared with a control condition.

Design: a case-control comparison nested within a single-blind, repeated-measures crossover design. ACLR participants complete three visits separated by at least 48 hours. Visit 1 is a baseline session with stair biomechanics assessed before and after a control condition (no vibration), plus gait biomechanics, isometric quadriceps and hamstring strength, single-leg and triple hop tests, and patient-reported outcomes. At visits 2 and 3, participants receive WBV and LMV in counterbalanced order, with stair biomechanics assessed immediately before and after the intervention. For all conditions, participants hold a squatted position (approximately 60 degrees of knee flexion) for 1 minute, repeated 6 times with 2 minutes of rest. WBV is delivered via a vibrating platform (30 Hz, 2 g). The control condition uses the same posture and timing without vibration. Healthy controls complete one visit identical to ACLR visit 1.

Biomechanics are collected with 3D motion capture synchronized with force plates under the second and third steps of an instrumented staircase. The data collector and outcome assessor are blinded to the vibration condition, which is administered by a separate research assistant.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

52

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Sansung Hwang, MS
  • Número de teléfono: 984-291-4830
  • Correo electrónico: sansungh@unc.edu

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

    • North Carolina
      • Chapel Hill, North Carolina, Estados Unidos, 27599
        • Motion Analysis Laboratory, University of North Carolina at Chapel Hill
        • Contacto:
          • Sansung Hwang, MS
          • Número de teléfono: 984-291-4830
          • Correo electrónico: sansungh@unc.edu
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 39 años (Adulto)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria (all participants):

  • Age 18 to 39 years
  • Able to read, understand, and communicate in English sufficiently to provide informed consent and follow instructions

Inclusion Criteria (ACLR group):

  • Primary, unilateral ACL reconstruction with patellar tendon autograft
  • 1 to 3 years after ACL reconstruction
  • Cleared by surgeon to return to unrestricted physical activity
  • Returned to unrestricted walking, stair negotiation, and hopping activities

Exclusion Criteria (ACLR group):

  • History of ACL injury to the opposite leg
  • History of any knee surgery other than ACL reconstruction
  • Diagnosis of osteoarthritis in any joint in either leg
  • Major lower extremity injury (requiring surgery or more than 3 weeks of medical treatment) in the previous 6 months
  • History of neurological disorder (e.g., stroke, cerebral palsy, multiple sclerosis)
  • Currently pregnant

Inclusion Criteria (healthy controls):

  • No history of ACL injury or knee surgery
  • No history of major lower extremity injury (requiring surgery or more than 3 weeks of medical treatment)
  • Matched to an ACLR participant by sex, age (within 3 years), and Tegner activity level (within 1 level)

Exclusion Criteria (healthy controls):

  • Diagnosis of osteoarthritis in any joint in either leg
  • Major lower extremity injury in the previous 6 months
  • History of neurological disorder (e.g., stroke, cerebral palsy, multiple sclerosis)
  • Currently pregnant

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Ciencia básica
  • Asignación: No aleatorizado
  • Modelo Intervencionista: Asignación cruzada
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: ACLR: WBV then LMV

Visit 1 control condition; Visit 2 whole-body vibration; Visit 3 local muscle vibration (at least 48 hours apart)

Standing on a vibrating platform (Power Plate Pro 5) in a squatted position (approximately 60 degrees of knee flexion), 30 Hz, 2 g, 1 minute x 6 exposures with 2 minutes of rest.

Otros nombres:
  • WBV

A vibration device secured over the quadriceps muscle belly while standing in the same squatted position on the deactivated platform, 30 Hz, 2 g, 1 minute x 6 exposures with 2 minutes of rest.

Otros nombres:
  • LMV

Same squatted position and timing (1 minute x 6 exposures with 2 minutes of rest) without vibration.

Experimental: ACLR: LMV then WBV

Visit 1 control condition; Visit 2 local muscle vibration; Visit 3 whole-body vibration (at least 48 hours apart)

Standing on a vibrating platform (Power Plate Pro 5) in a squatted position (approximately 60 degrees of knee flexion), 30 Hz, 2 g, 1 minute x 6 exposures with 2 minutes of rest.

Otros nombres:
  • WBV

A vibration device secured over the quadriceps muscle belly while standing in the same squatted position on the deactivated platform, 30 Hz, 2 g, 1 minute x 6 exposures with 2 minutes of rest.

Otros nombres:
  • LMV

Same squatted position and timing (1 minute x 6 exposures with 2 minutes of rest) without vibration.

Otro: Healthy controls

Single visit with the control condition; matched to ACLR participants by sex, age, (within 3 years), and Tegner activity level (within 1 level).

Same squatted position and timing (1 minute x 6 exposures with 2 minutes of rest) without vibration.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Peak Hip Flexion Angle
Periodo de tiempo: Gait: visit 1. Stair ascent and descent: visit 1 before and after the control condition, and visits 2 and 3 immediately before and after vibration (visits at least 48 hours apart, within about 2 weeks).

Maximum hip flexion angle during stance (degrees). Measured with 3D motion capture and force plates during the stance phase of preferred-speed overground gait, stair ascent, and stair descent (5 trials per task, averaged), in both limbs of participants with ACLR and healthy controls.

Gait: visit 1. Stair ascent and descent: visit 1 before and after the control condition, and visits 2 and 3 immediately before and after vibration (visits at least 48 hours apart, within about 2 weeks).
Peak Knee Flexion Angle
Periodo de tiempo: Gait: visit 1. Stair ascent and descent: visit 1 before and after the control condition, and visits 2 and 3 immediately before and after vibration (visits at least 48 hours apart, within about 2 weeks).

Maximum hip flexion angle during stance (degrees). Measured with 3D motion capture and force plates during the stance phase of preferred-speed overground gait, stair ascent, and stair descent (5 trials per task, averaged), in both limbs of participants with ACLR and healthy controls.

Gait: visit 1. Stair ascent and descent: visit 1 before and after the control condition, and visits 2 and 3 immediately before and after vibration (visits at least 48 hours apart, within about 2 weeks).
Peak Ankle Flexion Angle
Periodo de tiempo: Gait: visit 1. Stair ascent and descent: visit 1 before and after the control condition, and visits 2 and 3 immediately before and after vibration (visits at least 48 hours apart, within about 2 weeks).

Maximum ankle dorsiflexion angle during stance (degrees). Measured with 3D motion capture and force plates during the stance phase of preferred-speed overground gait, stair ascent, and stair descent (5 trials per task, averaged), in both limbs of participants with ACLR and healthy controls.

Gait: visit 1. Stair ascent and descent: visit 1 before and after the control condition, and visits 2 and 3 immediately before and after vibration (visits at least 48 hours apart, within about 2 weeks).
Knee Valgus Angle
Periodo de tiempo: Gait: visit 1. Stair ascent and descent: visit 1 before and after the control condition, and visits 2 and 3 immediately before and after vibration (visits at least 48 hours apart, within about 2 weeks).

Peak knee valgus (abduction) angle during stance (degrees). Measured with 3D motion capture and force plates during the stance phase of preferred-speed overground gait, stair ascent, and stair descent (5 trials per task, averaged), in both limbs of participants with ACLR and healthy controls.

Gait: visit 1. Stair ascent and descent: visit 1 before and after the control condition, and visits 2 and 3 immediately before and after vibration (visits at least 48 hours apart, within about 2 weeks).
Knee Flexion Displacement
Periodo de tiempo: Gait: visit 1. Stair ascent and descent: visit 1 before and after the control condition, and visits 2 and 3 immediately before and after vibration (visits at least 48 hours apart, within about 2 weeks).

Change in knee flexion angle from initial contact to peak knee flexion during stance (degrees). Measured with 3D motion capture and force plates during the stance phase of preferred-speed overground gait, stair ascent, and stair descent (5 trials per task, averaged), in both limbs of participants with ACLR and healthy controls.

Gait: visit 1. Stair ascent and descent: visit 1 before and after the control condition, and visits 2 and 3 immediately before and after vibration (visits at least 48 hours apart, within about 2 weeks).
Sagittal Plane Knee Moment
Periodo de tiempo: Gait: visit 1. Stair ascent and descent: visit 1 before and after the control condition, and visits 2 and 3 immediately before and after vibration (visits at least 48 hours apart, within about 2 weeks).

Peak internal knee extension moment during stance, normalized to body weight x height. Measured with 3D motion capture and force plates during the stance phase of preferred-speed overground gait, stair ascent, and stair descent (5 trials per task, averaged), in both limbs of participants with ACLR and healthy controls.

Gait: visit 1. Stair ascent and descent: visit 1 before and after the control condition, and visits 2 and 3 immediately before and after vibration (visits at least 48 hours apart, within about 2 weeks).
Frontal Plane Knee Moment
Periodo de tiempo: Gait: visit 1. Stair ascent and descent: visit 1 before and after the control condition, and visits 2 and 3 immediately before and after vibration (visits at least 48 hours apart, within about 2 weeks).

Peak internal knee abduction moment (equivalent to the external knee adduction moment) during stance, normalized to body weight x height. Measured with 3D motion capture and force plates during the stance phase of preferred-speed overground gait, stair ascent, and stair descent (5 trials per task, averaged), in both limbs of participants with ACLR and healthy controls.

Gait: visit 1. Stair ascent and descent: visit 1 before and after the control condition, and visits 2 and 3 immediately before and after vibration (visits at least 48 hours apart, within about 2 weeks).
Peak Vertical Ground Reaction Force
Periodo de tiempo: Gait: visit 1. Stair ascent and descent: visit 1 before and after the control condition, and visits 2 and 3 immediately before and after vibration (visits at least 48 hours apart, within about 2 weeks).

Peak vertical ground reaction force during stance, normalized to body weight (xBW). Measured with 3D motion capture and force plates during the stance phase of preferred-speed overground gait, stair ascent, and stair descent (5 trials per task, averaged), in both limbs of participants with ACLR and healthy controls.

Gait: visit 1. Stair ascent and descent: visit 1 before and after the control condition, and visits 2 and 3 immediately before and after vibration (visits at least 48 hours apart, within about 2 weeks).
Anterior Tibial Shear Force
Periodo de tiempo: Gait: visit 1. Stair ascent and descent: visit 1 before and after the control condition, and visits 2 and 3 immediately before and after vibration (visits at least 48 hours apart, within about 2 weeks).

Peak anterior tibial shear force during stance, normalized to body weight (xBW). Measured with 3D motion capture and force plates during the stance phase of preferred-speed overground gait, stair ascent, and stair descent (5 trials per task, averaged), in both limbs of participants with ACLR and healthy controls.

Gait: visit 1. Stair ascent and descent: visit 1 before and after the control condition, and visits 2 and 3 immediately before and after vibration (visits at least 48 hours apart, within about 2 weeks).
Isometric Quadriceps Peak Torque
Periodo de tiempo: Visit 1 (baseline)

Maximal voluntary isometric knee extension torque measured on an isokinetic dynamometer (knee flexed 90 degrees, hip flexed 85 degrees); mean of 3 contractions per limb, normalized to body mass (Nm/kg).

Visit 1 (baseline)
Isometric Hamstring Peak Torque
Periodo de tiempo: Visit 1 (baseline)

Maximal voluntary isometric knee flexion torque measured on an isokinetic dynamometer (knee flexed 90 degrees, hip flexed 85 degrees); mean of 3 contractions per limb, normalized to body mass (Nm/kg).

Visit 1 (baseline)
Quadriceps Rate of Torque Development
Periodo de tiempo: Visit 1 (baseline)

Rate of torque development during maximal voluntary isometric knee extension contractions; mean of 3 contractions per limb, normalized to body mass (Nm/kg/s).

Visit 1 (baseline)
Hamstring Rate of Torque Development
Periodo de tiempo: Visit 1 (baseline)

Rate of torque development during maximal voluntary isometric knee flexion contractions; mean of 3 contractions per limb, normalized to body mass (Nm/kg/s).

Visit 1 (baseline)
Single-Leg Hop for Distance
Periodo de tiempo: Visit 1 (baseline)

Distance hopped on one leg, measured from the take-off line to the landing point of the heel; mean of 3 successful trials per limb (cm).

Visit 1 (baseline)
Triple Hop for Distance
Periodo de tiempo: Visit 1 (baseline)

Distance covered in three consecutive hops on one leg, measured from the take-off line to the landing point of the heel; mean of 3 successful trials per limb (cm).

Visit 1 (baseline)

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
International Knee Documentation Committee (IKDC) Subjective Knee Form
Periodo de tiempo: Visit 1 (baseline)

Self-reported knee symptoms, function, and sports activity; score 0 to 100, higher scores indicate better knee function. Baseline patient-reported measure collected for participant characterization and prespecified covariate analyses.

Visit 1 (baseline)
Knee injury and Osteoarthritis Outcome Score (KOOS)
Periodo de tiempo: Visit 1 (baseline)

Five subscales (Pain, Symptoms, Activities of Daily Living, Sport and Recreation, Knee-Related Quality of Life), each scored 0 to 100, higher scores indicate fewer problems. Baseline patient-reported measure collected for participant characterization and prespecified covariate analyses.

Visit 1 (baseline)
Tampa Scale of Kinesiophobia (TSK-11)
Periodo de tiempo: Visit 1 (baseline)

Fear of movement and re-injury; score 11 to 44, higher scores indicate greater fear. Baseline patient-reported measure collected for participant characterization and prespecified covariate analyses.

Visit 1 (baseline)
Tegner Activity Scale
Periodo de tiempo: Visit 1 (baseline)

Activity level; score 0 to 10, higher scores indicate higher activity levels. Baseline patient-reported measure collected for participant characterization and prespecified covariate analyses.

Visit 1 (baseline)
Marx Activity Rating Scale
Periodo de tiempo: Visit 1 (baseline)

Frequency of running, cutting, decelerating, and pivoting; score 0 to 16, higher scores indicate more frequent activity. Baseline patient-reported measure collected for participant characterization and prespecified covariate analyses.

Visit 1 (baseline)
Anterior Cruciate Ligament Quality of Life (ACL-QOL) Questionnaire
Periodo de tiempo: Visit 1 (baseline)

ACL-specific quality of life; score 0 to 100, higher scores indicate better quality of life. Baseline patient-reported measure collected for participant characterization and prespecified covariate analyses.

Visit 1 (baseline)
ACL Reasons Survey
Periodo de tiempo: Visit 1 (baseline)

Self-reported return-to-activity status and reasons for limited physical activity after ACL injury. The survey has no total score. Responses will be reported descriptively as the number (%) of participants cleared to return to unrestricted activity, the number (%) in each activity category (as physically active as before injury; as active but participation is more challenging; less active than before injury), the number (%) selecting each of the 14 listed reasons, and the number (%) ranking each reason as most important. Reported for participants with ACLR. Baseline patient-reported measure collected for participant characterization and prespecified covariate analyses.

Visit 1 (baseline)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Sansung Hwang, MS, University of North Carolina, Chapel Hill
  • Silla de estudio: Troy Blackburn, PhD, University of North Carolina, Chapel Hill

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de noviembre de 2026

Finalización primaria (Estimado)

1 de noviembre de 2028

Finalización del estudio (Estimado)

1 de noviembre de 2028

Fechas de registro del estudio

Enviado por primera vez

2 de noviembre de 2026

Primero enviado que cumplió con los criterios de control de calidad

2 de noviembre de 2026

Publicado por primera vez (Actual)

6 de noviembre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

6 de noviembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

2 de noviembre de 2026

Última verificación

1 de octubre de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 26-0478
  • 26-SRC049 (Otro identificador: UNC-CH Scientific Review Committee)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

Individual participant data will not be shared outside the research team. Study results will be reported in aggregate in publications and presentations, and the informed consent does not include provisions for sharing individual-level data with other researchers or public repositories.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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