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

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ClinicalTrials.gov Identifier: NCT02605876
Recruitment Status : Recruiting
First Posted : November 16, 2015
Last Update Posted : September 15, 2017
Sponsor:
Information provided by (Responsible Party):
Troy Blackburn, PhD, ATC, University of North Carolina, Chapel Hill

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.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Device: Whole body vibration Device: Local muscle vibration Not Applicable

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Basic Science
Actual Study Start Date : October 1, 2015
Estimated Primary Completion Date : September 30, 2018
Estimated Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: Whole Body Vibration
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
Experimental: Local Muscle Vibration
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
No Intervention: Control
Subjects will perform the same procedures as the experimental groups with the exception that no vibratory stimulus will be applied.



Primary Outcome Measures :
  1. Change from baseline ground reaction force loading rate during walking gait immediately following vibration interventions [ Time Frame: Prior to and immediately following vibration interventions (i.e. acute effects) ]
    Ground reaction force loading rate during walking gait

  2. Change from baseline quadriceps strength immediately following vibration interventions assessed by peak torque during maximal quadriceps activation [ Time Frame: Prior to and immediately following vibration interventions (i.e. acute effects) ]
    Peak torque during maximal quadriceps activation

  3. Change from baseline knee proprioception immediately following vibration interventions assessed by joint reposition error [ Time Frame: Prior to and immediately following vibration interventions (i.e. acute effects) ]
    Joint reposition error



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02605876


Contacts
Contact: Troy Blackburn, PhD 919-843-2021 troyb@email.unc.edu
Contact: Brian Pietrosimone, PhD 919-962-3617 pietrosi@email.unc.edu

Locations
United States, North Carolina
Neuromuscular Research Lab, University of North Carolina at Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Troy Blackburn, PhD    919-843-2021    troyb@email.unc.edu   
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Troy Blackburn, PhD University of North Carolina, Chapel Hill

Responsible Party: Troy Blackburn, PhD, ATC, Associate Professor, Department of Exercise & Sport Science, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02605876     History of Changes
Other Study ID Numbers: 15-0838
First Posted: November 16, 2015    Key Record Dates
Last Update Posted: September 15, 2017
Last Verified: September 2017

Keywords provided by Troy Blackburn, PhD, ATC, University of North Carolina, Chapel Hill:
anterior cruciate ligament reconstruction

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases