NCT02851316

Brief Summary

Whole body vibration (WBV) acutely improves quadriceps strength, and may improve long-term outcomes in individuals with anterior cruciate ligament reconstruction (ACLR). However, it is unclear if WBV influences athletic tasks such as running. The purpose of this study is to evaluate the influence of WBV on running biomechanics in individuals with ACLR.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Jul 2016

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

July 1, 2016

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

July 19, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 1, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

August 15, 2019

Status Verified

August 1, 2019

Enrollment Period

1.2 years

First QC Date

July 19, 2016

Last Update Submit

August 13, 2019

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (3)

  • Change in ground reaction force

    Ground reaction force during running gait

    Day 1, Prior to and immediately following vibration intervention in a single session (i.e. - acute effects)

  • Change in ground reaction force loading rate

    Ground reaction force loading rate during running gait

    Day 1, Prior to and immediately following vibration intervention in a single session (i.e. acute effects)

  • Change in knee flexion excursion

    Knee flexion excursion during running gait

    Day 1, Prior to and immediately following vibration intervention in a single session (i.e. acute effects)

Study Arms (2)

Whole Body Vibration

EXPERIMENTAL

The WBV intervention consists of 6 bouts of 60 seconds vibration with 2 minutes of rest in between (30Hz, 2g acceleration) while participants stand on a vibrating platform with their knees bent.

Other: Whole Body Vibration

Control

NO INTERVENTION

The control intervention consists of 6 bouts of 60 seconds with 2 minutes of rest in between while participants stand with their knees bent (no vibration applied).

Interventions

Whole Body VibrationOTHER

Participants will stand in a squatted position on a platform that provides a brief vibratory stimuli.

Whole Body Vibration

Eligibility Criteria

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

You may qualify if:

  • years
  • Unilateral ACL reconstruction
  • At least 6 months post-reconstruction
  • Recreationally active (at least 20 minutes of physical activity 3 times per week)

You may not qualify if:

  • History of ACL graft rupture or revision surgery
  • Neurological disorder
  • Other lower extremity within the 6 months prior to participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CSU Fullerton: Biomechanics Laboratory (KHS 021)

Fullerton, California, 92831, United States

Location

Related Publications (1)

  • Pamukoff DN, Montgomery MM, Choe KH, Moffit TJ, Vakula MN. Effect of Whole-Body Vibration on Sagittal Plane Running Mechanics in Individuals With Anterior Cruciate Ligament Reconstruction: A Randomized Crossover Trial. Arch Phys Med Rehabil. 2018 May;99(5):973-980. doi: 10.1016/j.apmr.2017.11.019. Epub 2018 Jan 31.

    PMID: 29407520DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Derek N Pamukoff, PhD

    California State University, Fullerton

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 19, 2016

First Posted

August 1, 2016

Study Start

July 1, 2016

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

August 15, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)