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

NCT ID: NCT02605876

Last Updated: 2019-11-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-01

Study Completion Date

2018-12-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Whole body vibration

Intervention Type DEVICE

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.

Group Type EXPERIMENTAL

Local muscle vibration

Intervention Type DEVICE

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Whole body vibration

Intervention Type DEVICE

Local muscle vibration

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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United States Department of Defense

FED

Sponsor Role collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Troy Blackburn, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

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Neuromuscular Research Lab, University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 32757272 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31608488 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31121428 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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15-0838

Identifier Type: -

Identifier Source: org_study_id

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