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Stair Biomechanics and Vibration Study After ACLR

2 listopada 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

52

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

  • Nazwa: Sansung Hwang, MS
  • Numer telefonu: 984-291-4830
  • E-mail: sansungh@unc.edu

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

    • North Carolina
      • Chapel Hill, North Carolina, Stany Zjednoczone, 27599
        • Motion Analysis Laboratory, University of North Carolina at Chapel Hill
        • Kontakt:
        • Kontakt:

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat do 39 lat (Dorosły)

Akceptuje zdrowych ochotników

Tak

Płeć kwalifikująca się do nauki

Wszystko

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Podstawowa nauka
  • Przydział: Nielosowe
  • Model interwencyjny: Zadanie krzyżowe
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.

Inne nazwy:
  • 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.

Inne nazwy:
  • LMV

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

Eksperymentalny: 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.

Inne nazwy:
  • 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.

Inne nazwy:
  • LMV

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

Inny: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Peak Hip Flexion Angle
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
International Knee Documentation Committee (IKDC) Subjective Knee Form
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Śledczy

  • Główny śledczy: Sansung Hwang, MS, University of North Carolina, Chapel Hill
  • Krzesło do nauki: Troy Blackburn, PhD, University of North Carolina, Chapel Hill

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 listopada 2026

Zakończenie podstawowe (Szacowany)

1 listopada 2028

Ukończenie studiów (Szacowany)

1 listopada 2028

Daty rejestracji na studia

Pierwszy przesłany

2 listopada 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

2 listopada 2026

Pierwszy wysłany (Rzeczywisty)

6 listopada 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

6 listopada 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

2 listopada 2026

Ostatnia weryfikacja

1 października 2026

Więcej informacji

Terminy związane z tym badaniem

Inne numery identyfikacyjne badania

  • 26-0478
  • 26-SRC049 (Inny identyfikator: UNC-CH Scientific Review Committee)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu 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.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .