此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Stair Biomechanics and Vibration Study After ACLR

2026年11月2日 更新者: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.

研究概览

详细说明

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.

研究类型

介入性

注册 (估计的)

52

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名:Sansung Hwang, MS
  • 电话号码:984-291-4830
  • 邮箱:sansungh@unc.edu

研究联系人备份

学习地点

    • North Carolina
      • Chapel Hill、North Carolina、美国、27599
        • Motion Analysis Laboratory, University of North Carolina at Chapel Hill
        • 接触:
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 39年 (成人)

接受健康志愿者

是的

有资格学习的性别

全部

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:基础科学
  • 分配:非随机化
  • 介入模型:交叉作业
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的: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.

其他名称:
  • 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.

其他名称:
  • LMV

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

实验性的: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.

其他名称:
  • 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.

其他名称:
  • LMV

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

其他: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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Peak Hip Flexion Angle
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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)

其他结果措施

结果测量
措施说明
大体时间
International Knee Documentation Committee (IKDC) Subjective Knee Form
大体时间: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)
大体时间: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)
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Sansung Hwang, MS、University of North Carolina, Chapel Hill
  • 学习椅:Troy Blackburn, PhD、University of North Carolina, Chapel Hill

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年11月1日

初级完成 (估计的)

2028年11月1日

研究完成 (估计的)

2028年11月1日

研究注册日期

首次提交

2026年11月2日

首先提交符合 QC 标准的

2026年11月2日

首次发布 (实际的)

2026年11月6日

研究记录更新

最后更新发布 (实际的)

2026年11月6日

上次提交的符合 QC 标准的更新

2026年11月2日

最后验证

2026年10月1日

更多信息

与本研究相关的术语

其他研究编号

  • 26-0478
  • 26-SRC049 (其他标识符:UNC-CH Scientific Review Committee)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

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.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅