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

• Sponsor: University of North Carolina, Chapel Hill (Other)
• Overall Status: Completed
• CT.gov ID: NCT02605876
• Collaborator: United States Department of Defense (U.S. Fed)
• Enrollment: 75
• Location: 1
• Arms: 3
• Actual Duration (Months): 39
• Patients Per Site Per Month: 1.9

Study Details

Study Description

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	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 75 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Basic Science
• Official Title: Vibratory Stimuli: A Novel Rehabilitation Method for Preventing Post-traumatic Knee Osteoarthritis
• Actual Study Start Date: Oct 1, 2015
• Actual Primary Completion Date: Dec 30, 2018
• Actual Study Completion Date: Dec 30, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Linear Ground Reaction Force Loading Rate [Prior to and immediately following vibration interventions (within 5 minutes).]

   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.

2. Quadriceps Strength [Prior to and immediately following vibration interventions (within 10 minutes)]

   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.

3. Knee Proprioception [Prior to and immediately following vibration interventions (within 5 minutes)]

   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.

4. Instantaneous Ground Reaction Force Loading Rate [Immediately prior to and following the interventions (within 5 minutes)]

   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.

Secondary Outcome Measures

1. Peak Internal Knee Extension Moment [Immediately prior to and following the interventions (within 5 minutes)]

   Change score (Post-Pre) for the peak internal knee extension moment during the first 50% of the stance phase. This value reflects the internal (i.e. muscle and other soft tissue) response to external loading of the knee joint in the sagittal plane of motion, and is indicative of quadriceps muscle function during walking. Though a "normal" value has not been established, typical values for the raw scores (i.e. not change scores) range 2-4 % body weight x height.

2. Peak Internal Knee Valgus Moment [Immediately prior to and following the interventions (within 5 minutes)]

   Change score (Post-Pre) for the peak internal knee valgus moment during the first 50% of the stance phase. This value reflects the internal (i.e. muscle and other soft tissue) response to external loading of the knee joint in the frontal plane of motion, and is indicative of medial tibiofemoral joint loading during walking. Though a "normal" value has not been established, typical values for the raw scores (i.e. not change scores) range 2-4 % body weight x height.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 35 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Neuromuscular Research Lab, University of North Carolina at Chapel Hill	Chapel Hill	North Carolina	United States	27599

Sponsors and Collaborators

• University of North Carolina, Chapel Hill
• United States Department of Defense

Investigators

• Principal Investigator: Troy Blackburn, PhD, University of North Carolina, Chapel Hill

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 14, 2019

More Information

Publications

None provided.

• Responsible Party: University of North Carolina, Chapel Hill
• ClinicalTrials.gov Identifier: NCT02605876
• Other Study ID Numbers: 15-0838
• First Posted: Nov 16, 2015
• Last Update Posted: Nov 19, 2019
• Last Verified: Oct 1, 2019

• Keywords provided by University of North Carolina, Chapel Hill: anterior cruciate ligament reconstruction
• Additional relevant MeSH terms: Osteoarthritis; Osteoarthritis, Knee

Study Results

Participant Flow

Recruitment Details	A convenience sample was recruited from local rehabilitation clinics, the University population, the local population, and a nearby Veterans Affairs Medical Center.

Arm/Group Title	Whole Body Vibration	Local Muscle Vibration	Control
Arm/Group Description	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. Whole body 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. Local muscle vibration	Subjects will perform the same procedures as the experimental groups with the exception that no vibratory stimulus will be applied.
Period Title: Overall Study
STARTED	25	25	25
COMPLETED	25	25	25
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	Whole Body Vibration	Local Muscle Vibration	Control	Total
Arm/Group Description	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. Whole body 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. Local muscle vibration	Subjects will perform the same procedures as the experimental groups with the exception that no vibratory stimulus will be applied.	Total of all reporting groups
Overall Participants	25	25	25	75
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	25 100%	25 100%	25 100%	75 100%
>=65 years	0 0%	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	20 (2)	20 (3)	21 (4)	21 (3)
Sex: Female, Male (Count of Participants)
Female	18 72%	19 76%	17 68%	54 72%
Male	7 28%	6 24%	8 32%	21 28%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (Count of Participants)
United States	25 100%	25 100%	25 100%	75 100%

Outcome Measures

1. Primary Outcome

Title	Linear Ground Reaction Force Loading Rate
Description	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.
Time Frame	Prior to and immediately following vibration interventions (within 5 minutes).

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Whole Body Vibration	Local Muscle Vibration	Control
Arm/Group Description	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. Whole body 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. Local muscle vibration	Subjects will perform the same procedures as the experimental groups with the exception that no vibratory stimulus will be applied.
Measure Participants	25	25	25
Mean (95% Confidence Interval) [multiples of body weight per second]	0.276	-0.146	-0.135

2. Primary Outcome

Title	Quadriceps Strength
Description	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.
Time Frame	Prior to and immediately following vibration interventions (within 10 minutes)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Whole Body Vibration	Local Muscle Vibration	Control
Arm/Group Description	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. Whole body 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. Local muscle vibration	Subjects will perform the same procedures as the experimental groups with the exception that no vibratory stimulus will be applied.
Measure Participants	25	25	25
Mean (95% Confidence Interval) [Newton*meters/kilogram body mass]	0.05	-0.13	-0.09

3. Primary Outcome

Title	Knee Proprioception
Description	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.
Time Frame	Prior to and immediately following vibration interventions (within 5 minutes)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Whole Body Vibration	Local Muscle Vibration	Control
Arm/Group Description	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. Whole body 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. Local muscle vibration	Subjects will perform the same procedures as the experimental groups with the exception that no vibratory stimulus will be applied.
Measure Participants	25	25	25
Mean (95% Confidence Interval) [degrees]	-0.71	-0.61	-0.08

4. Primary Outcome

Title	Instantaneous Ground Reaction Force Loading Rate
Description	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.
Time Frame	Immediately prior to and following the interventions (within 5 minutes)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Whole Body Vibration	Local Muscle Vibration	Control
Arm/Group Description	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. Whole body 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. Local muscle vibration	Subjects will perform the same procedures as the experimental groups with the exception that no vibratory stimulus will be applied.
Measure Participants	25	25	25
Mean (95% Confidence Interval) [multiples of body weight per second]	-0.333	-3.552	0.473

5. Secondary Outcome

Title	Peak Internal Knee Extension Moment
Description	Change score (Post-Pre) for the peak internal knee extension moment during the first 50% of the stance phase. This value reflects the internal (i.e. muscle and other soft tissue) response to external loading of the knee joint in the sagittal plane of motion, and is indicative of quadriceps muscle function during walking. Though a "normal" value has not been established, typical values for the raw scores (i.e. not change scores) range 2-4 % body weight x height.
Time Frame	Immediately prior to and following the interventions (within 5 minutes)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Whole Body Vibration	Local Muscle Vibration	Control
Arm/Group Description	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. Whole body 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. Local muscle vibration	Subjects will perform the same procedures as the experimental groups with the exception that no vibratory stimulus will be applied.
Measure Participants	25	25	25
Mean (95% Confidence Interval) [% body weight x height]	0.271	0.014	-0.17

6. Secondary Outcome

Title	Peak Internal Knee Valgus Moment
Description	Change score (Post-Pre) for the peak internal knee valgus moment during the first 50% of the stance phase. This value reflects the internal (i.e. muscle and other soft tissue) response to external loading of the knee joint in the frontal plane of motion, and is indicative of medial tibiofemoral joint loading during walking. Though a "normal" value has not been established, typical values for the raw scores (i.e. not change scores) range 2-4 % body weight x height.
Time Frame	Immediately prior to and following the interventions (within 5 minutes)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Whole Body Vibration	Local Muscle Vibration	Control
Arm/Group Description	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. Whole body 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. Local muscle vibration	Subjects will perform the same procedures as the experimental groups with the exception that no vibratory stimulus will be applied.
Measure Participants	25	25	25
Mean (95% Confidence Interval) [% body weight x height]	-0.450	-0.436	-0.304

Adverse Events

Time Frame	Each participant was enrolled in the study for approximately 3 weeks over which AEs were evaluated. No follow up assessments occurred once participation was complete. Participants were asked to follow up with research team in the event that they experienced any adverse events, but were not directly evaluated.
Arm/Group Title	Whole Body Vibration		Local Muscle Vibration		Control
Arm/Group Description	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. Whole body 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. Local muscle vibration		Subjects will perform the same procedures as the experimental groups with the exception that no vibratory stimulus will be applied.
All Cause Mortality
	Whole Body Vibration		Local Muscle Vibration		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/25 (0%)		0/25 (0%)
Serious Adverse Events
	Whole Body Vibration		Local Muscle Vibration		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/25 (0%)		0/25 (0%)
Other (Not Including Serious) Adverse Events
	Whole Body Vibration		Local Muscle Vibration		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/25 (0%)		0/25 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.