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Stair Biomechanics and Vibration Study After ACLR

2026. november 2. frissítette: 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.

A tanulmány áttekintése

Részletes leírás

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.

Tanulmány típusa

Beavatkozó

Beiratkozás (Becsült)

52

Fázis

  • Nem alkalmazható

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi kapcsolat

Tanulmányozza a kapcsolattartók biztonsági mentését

Tanulmányi helyek

    • North Carolina
      • Chapel Hill, North Carolina, Egyesült Államok, 27599
        • Motion Analysis Laboratory, University of North Carolina at Chapel Hill
        • Kapcsolatba lépni:
        • Kapcsolatba lépni:

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

18 év (Felnőtt)

Egészséges önkénteseket fogad

Igen

Tanulmányozható nemek

Összes

Leírás

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

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

  • Elsődleges cél: Alapvető tudomány
  • Kiosztás: Nem véletlenszerű
  • Beavatkozó modell: Crossover kiosztás
  • Maszkolás: Egyetlen

Fegyverek és beavatkozások

Résztvevő csoport / kar
Beavatkozás / kezelés
Kísérleti: 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.

Más nevek:
  • 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.

Más nevek:
  • LMV

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

Kísérleti: 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.

Más nevek:
  • 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.

Más nevek:
  • LMV

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

Egyéb: 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.

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Peak Hip Flexion Angle
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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)

Egyéb eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
International Knee Documentation Committee (IKDC) Subjective Knee Form
Időkeret: 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)
Időkeret: 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)
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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)

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Nyomozók

  • Kutatásvezető: Sansung Hwang, MS, University of North Carolina, Chapel Hill
  • Tanulmányi szék: Troy Blackburn, PhD, University of North Carolina, Chapel Hill

Publikációk és hasznos linkek

A vizsgálattal kapcsolatos információk beviteléért felelős személy önkéntesen bocsátja rendelkezésre ezeket a kiadványokat. Ezek bármiről szólhatnak, ami a tanulmányhoz kapcsolódik.

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete (Becsült)

2026. november 1.

Elsődleges befejezés (Becsült)

2028. november 1.

A tanulmány befejezése (Becsült)

2028. november 1.

Tanulmányi regisztráció dátumai

Először benyújtva

2026. november 2.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

2026. november 2.

Első közzététel (Tényleges)

2026. november 6.

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Tényleges)

2026. november 6.

Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak

2026. november 2.

Utolsó ellenőrzés

2026. október 1.

Több információ

A tanulmányhoz kapcsolódó kifejezések

Egyéb vizsgálati azonosító számok

  • 26-0478
  • 26-SRC049 (Egyéb azonosító: UNC-CH Scientific Review Committee)

Terv az egyéni résztvevői adatokhoz (IPD)

Tervezi megosztani az egyéni résztvevői adatokat (IPD)?

NEM

IPD terv leírása

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.

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