NCT02605876

Brief Summary

This study will evaluate the acute effects of vibration (whole body vibration and local muscle vibration) on quadriceps function, knee joint proprioception, and gait biomechanics linked to osteoarthritis development in individuals with anterior cruciate ligament reconstruction. Subjects will be randomly assigned to control (no vibration), whole body vibration, and local muscle vibration groups, and the aforementioned characteristics will be assessed prior to and following the respective interventions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Oct 2015

Longer than P75 for not_applicable knee-osteoarthritis

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 6, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 16, 2015

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2018

Completed
11 months until next milestone

Results Posted

Study results publicly available

November 19, 2019

Completed
Last Updated

November 19, 2019

Status Verified

October 1, 2019

Enrollment Period

3.2 years

First QC Date

November 6, 2015

Results QC Date

October 24, 2019

Last Update Submit

November 15, 2019

Conditions

Knee Osteoarthritis

Keywords

anterior cruciate ligament reconstruction

Outcome Measures

Primary Outcomes (4)

  • Linear Ground Reaction Force Loading Rate

    Change score (Post-Pre) for the ground reaction force during the first 50% of the stance phase calculated as the slope of the vertical ground reaction force time series curve from heelstrike to the first ground reaction force peak. Though a "normal" value has not been established, typical values for the raw scores (i.e. not change scores) range 8.5-9.5 multiples of body weight per second.

    Prior to and immediately following vibration interventions (within 5 minutes).

  • Quadriceps Strength

    Change score (Post-Pre) for maximal isometric knee extension peak torque in Newton\*meters/kilogram body mass. Though a "normal" value has not been established, typical values for the raw values (i.e. not changes scores) range 1.5-3.5 Newton\*meters/kilogram body mass.

    Prior to and immediately following vibration interventions (within 10 minutes)

  • Knee Proprioception

    Change score (Post-Pre) for the absolute sagittal plane joint reposition error. This value, measured in degrees, represents the absolute difference between a target knee flexion angle and the angle the subject reproduces, and assesses how well the subject can perceive the position of his/her knee in space. Typical values for the raw scores (i.e. not change scores) range from 0.5 - 5 degrees.

    Prior to and immediately following vibration interventions (within 5 minutes)

  • Instantaneous Ground Reaction Force Loading Rate

    Change score (Post-Pre) loading rate calculated as the peak of the first time derivative of the vertical ground reaction force time series curve during the first 50% of the stance phase. Though a "normal" value has not been established, typical values for the raw scores (i.e. not change scores) range 50-70 multiples of body weight per second.

    Immediately prior to and following the interventions (within 5 minutes)

Secondary Outcomes (2)

  • Peak Internal Knee Extension Moment

    Immediately prior to and following the interventions (within 5 minutes)

  • Peak Internal Knee Valgus Moment

    Immediately prior to and following the interventions (within 5 minutes)

Study Arms (3)

Whole Body Vibration

EXPERIMENTAL

Subjects will receive whole body vibration (30Hz, 2g) applied continuously for 1 minute. This exposure will be repeated 6 times with 2 minutes of rest between exposures.

Device: Whole body vibration

Local Muscle Vibration

EXPERIMENTAL

Subjects will receive local muscle vibration (30Hz, 2g) applied continuously for 1 minute. This exposure will be repeated 6 times with 2 minutes of rest between exposures.

Device: Local muscle vibration

Control

NO INTERVENTION

Subjects will perform the same procedures as the experimental groups with the exception that no vibratory stimulus will be applied.

Interventions

Whole body vibrationDEVICE
Whole Body Vibration
Local muscle vibrationDEVICE
Local Muscle Vibration

Eligibility Criteria

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

You may qualify if:

  • age 18-35 years
  • undergone unilateral ACLR within 5 years prior to participation
  • at least 6 months post-ACLR
  • Knee Injury and Osteoarthritis Outcome Score (KOOS) self-report survey Pain subscale score \> 53.1 and Symptom subscale score \> 44.9
  • cleared by a physician for return to physical activity, and currently participating in at least 20 minutes of physical activity 3x per week.

You may not qualify if:

  • central activation ratio (CAR) \> 95%
  • history of ACL graft rupture or revision surgery, neurological disorder, or injury to either leg within 6 months prior to participation (other than the initial ACLR)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neuromuscular Research Lab, University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (3)

  • Blackburn T, Padua DA, Pietrosimone B, Schwartz TA, Spang JT, Goodwin JS, Dewig DR, Johnston CD. Vibration improves gait biomechanics linked to posttraumatic knee osteoarthritis following anterior cruciate ligament injury. J Orthop Res. 2021 May;39(5):1113-1122. doi: 10.1002/jor.24821. Epub 2020 Aug 12.

    PMID: 32757272DERIVED

  • Blackburn JT, Pietrosimone B, Spang JT, Goodwin JS, Johnston CD. Somatosensory Function Influences Aberrant Gait Biomechanics Following Anterior Cruciate Ligament Reconstruction. J Orthop Res. 2020 Mar;38(3):620-628. doi: 10.1002/jor.24495. Epub 2019 Oct 24.

    PMID: 31608488DERIVED

  • Blackburn T, Pietrosimone B, Goodwin JS, Johnston C, Spang JT. Co-activation during gait following anterior cruciate ligament reconstruction. Clin Biomech (Bristol). 2019 Jul;67:153-159. doi: 10.1016/j.clinbiomech.2019.05.010. Epub 2019 May 9.

    PMID: 31121428DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Results Point of Contact

Title
Troy Blackburn
Organization
University of North Carolina at Chapel Hill
troyb@email.unc.edu
9198432021

Study Officials

  • Troy Blackburn, PhD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2015

First Posted

November 16, 2015

Study Start

October 1, 2015

Primary Completion

December 30, 2018

Study Completion

December 30, 2018

Last Updated

November 19, 2019

Results First Posted

November 19, 2019

Record last verified: 2019-10

Locations

US(1)