NCT07681193

Brief Summary

Individuals who undergo anterior cruciate ligament reconstruction (ACLR) are at heightened risk of secondary anterior cruciate ligament (ACL) injury (e.g. additional injury to the ACL in either knee). One of the primary physiological consequences of ACLR is the presence of quadriceps dysfunction (i.e. reduced activation and strength) which has been linked to altered gait and landing biomechanics. Aberrant landing biomechanics have been associated with an increased risk of both primary and secondary ACL injury, thus additional research is needed to evaluate the efficacy of treatments aimed to reduce quadriceps dysfunction and restore adequate landing biomechanics in attempts to reduce secondary ACL injury. Whole-body Vibration (WBV) has demonstrated success in improving quadriceps function and gait biomechanics in individuals with ACLR, however its effectiveness on landing biomechanics is unknown. To evaluate the acute effects of WBV on landing biomechanics in those with ACLR, a non-randomized crossover-controlled trial was conducted to determine if a single bout of WBV improved landing biomechanics greater than a control condition. Participants completed two separate testing sessions (separated by at least one week) in which measures of quadriceps function and landing biomechanics were assessed before and after either a control (no WBV) or WBV intervention. Separate linear mixed-effects models of post-test values for each dependent outcome were conducted with condition (control vs WBV) and limb (ACLR vs Uninvolved) as an interaction term, and each condition pre-test values and time post-ACLR as fixed effect covariates and a random effect of subject. The investigators expect to observe a significant improvement in landing biomechanics following WBV compared to the control condition.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 22, 2022

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2022

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

June 10, 2026

Completed
22 days until next milestone

First Posted

Study publicly available on registry

July 2, 2026

Completed
Last Updated

July 2, 2026

Status Verified

June 1, 2026

Enrollment Period

8 months

First QC Date

June 10, 2026

Last Update Submit

June 25, 2026

Conditions

Keywords

vibrationquadricepssecondary injuryACL reconstructionLanding biomechanics

Outcome Measures

Primary Outcomes (3)

  • Internal Knee Adduction Moment (KAM)

    Peak value during landing in both single-leg and double-leg tasks averaged over 3 trials and normalized to the product of body weight and height

    Separate values prior to and immediately following the intervention (within 5 minutes).

  • Internal Knee Extension Moment (KEM)

    Peak value during landing in both single-leg and double-leg tasks averaged over 3 trials and normalized to a product of body weight\*height

    Separate values prior to and immediately following the intervention (within 5 minutes).

  • Knee Flexion Angle (KFA)

    Peak value during landing in both single-leg and double-leg tasks averaged over 3 trials

    Separate values prior to and immediately following the intervention (within 5 minutes).

Secondary Outcomes (3)

  • Dynamic Postural Control

    Separate values prior to and immediately following the intervention (within 5 minutes).

  • Vertical Ground Reaction Force

    Separate values prior to and immediately following the intervention (within 5 minutes).

  • Frontal Plane Kinematics

    Separate values prior to and immediately following the intervention (within 5 minutes).

Study Arms (2)

Whole body vibration followed by No Intervention (Control)

EXPERIMENTAL

Participants in this arm will receive Whole Body Vibration followed by a washout period of 1 week, then receive the Sham Whole body vibration (Control). Each condition will be evaluated in a single session (i.e. acute effects).

Other: Whole body vibration (WBV)Other: Sham Whole body vibration

Sham Whole body vibration (Control) followed by Whole Body Vibration

EXPERIMENTAL

Participants in this arm will receive Sham Whole body vibration (Control) followed by a washout period of 1 week, then receive Whole Body Vibration. Each condition will be evaluated in a single session (i.e. acute effects).

Other: Whole body vibration (WBV)Other: Sham Whole body vibration

Interventions

Participants will stand on a WBV platform in a mini-squat position while vibration is applied during six 60-second bouts with 2 minutes of rest between each bout. WBV will be delivered at an acceleration of 2g and a frequency of 30 Hz.

Sham Whole body vibration (Control) followed by Whole Body VibrationWhole body vibration followed by No Intervention (Control)

Participants will stand on a WBV platform in a mini-squat position during six 60-second bouts with 2 minutes of rest between each bout. No vibration will be applied.

Sham Whole body vibration (Control) followed by Whole Body VibrationWhole body vibration followed by No Intervention (Control)

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Between the ages of 18-35
  • History of primary, unilateral ACLR
  • Medically cleared for unrestricted physical activity

You may not qualify if:

  • More than 5 years removed from ACLR
  • Currently pregnant
  • History of other lower extremity surgery
  • History of lower extremity injury in previous 6 months
  • History of neurological disorder
  • Maximal isometric quadriceps torque \> 3.0 Nm/kg in the ACLR limb

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Univesrity of North Carolina at Chapel HIll MOTION Science Institute

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Officials

  • Derek Dewig

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2026

First Posted

July 2, 2026

Study Start

September 1, 2021

Primary Completion

April 22, 2022

Study Completion

May 10, 2022

Last Updated

July 2, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will share

Deidentified individual data that supports the results will be shared beginning 9 and continuing for 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.

Shared Documents
STUDY PROTOCOL
Time Frame
IPD will be available beginning 9 and continuing for 36 months following publication.
Access Criteria
Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

Locations