Vibratory Stimuli, A Novel Rehabilitation Method for Preventing Post - Traumatic Knee Osteoarthritis

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 35 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 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.

Exclusion Criteria:

- 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)

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02605876
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of North Carolina, Chapel Hill
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Troy Blackburn, PhD
Principal Investigator Affiliation University of North Carolina, Chapel Hill
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Knee Osteoarthritis
Additional Details

Quadriceps muscle dysfunction and proprioceptive deficits following knee injuries alter walking gait biomechanics in manners that contribute to development of knee osteoarthritis. Current rehabilitation techniques are minimally effective for addressing these complications and preventing knee osteoarthritis. Anterior cruciate ligament reconstruction dramatically increases the risk of knee osteoarthritis, and represents an ideal model for evaluating novel rehabilitation techniques for preventing knee osteoarthritis. Direct (local muscle vibration) and indirect (whole body vibration) vibratory stimuli enhance quadriceps function and proprioception, and may improve rehabilitation and reduce the risk of knee osteoarthritis. The purpose of this investigation is to determine and compare the acute effects of whole body vibration and local muscle vibration on quadriceps function, knee proprioception, and gait biomechanics in individuals with anterior cruciate ligament reconstruction. The investigators hypothesize that vibratory stimuli will enhance quadriceps function, knee proprioception, and gait biomechanics in manners that would reduce the risk of developing knee osteoarthritis, and that whole body vibration and local muscle vibration will produce equivalent improvements in these characteristics.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Chapel Hill, North Carolina

Status

Recruiting

Address

Neuromuscular Research Lab, University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599

Site Contact

Troy Blackburn, PhD

[email protected]

919-843-2021