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The Design and Evaluation of an Active Intervention for the Prevention of Non-contact ACL Injury

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01021111
First Posted: November 26, 2009
Last Update Posted: April 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Thomas Peter Andriacchi, Stanford University
  Purpose
The overall goal of this project is to reduce the risk for anterior cruciate ligament injuries by designing a targeted intervention that will alter the known kinematic and kinetic risk factors associated with ACL injuries.

Condition Intervention
Athletic Injuries Sprains and Strains Wounds and Injuries Knee Injuries Device: Activity Training with Feedback

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Design and Evaluation of an Active Intervention for the Prevention of Non-contact ACL Injury

Further study details as provided by Thomas Peter Andriacchi, Stanford University:

Primary Outcome Measures:
  • Knee Flexion Angle and Trunk Flexion Angle After Activity Training With Feedback [ Time Frame: 1 day ]
    Knee flexion angle describes the angle between the tibia and femur during the activity. Trunk flexion is the angle between the shoulders and the hips during the activity.


Secondary Outcome Measures:
  • Thigh Coronal Angular Velocity After Feedback Training [ Time Frame: 1 day ]
    How fast the thigh is moving relative to the tibia during the activity, measured in degrees/second.


Enrollment: 17
Study Start Date: November 2009
Study Completion Date: December 2014
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Activity Training with Feedback
Subject is tested prior to training and retested with feedback training designed to modify the mechanics of landing during jumping and running activities
Device: Activity Training with Feedback
The feedback system consisted of three small inertial measurement units affixed on the chest, thigh, and shank segment respectively. These units were connected to a computer that recorded the signal from the inertial sensors at 240 Hz during the jump task. Using custom software, the knee flexion angle, trunk lean, and coronal thigh angular velocity were calculated immediately after the subject completed the jump trial. A projector was used to display the results of the jump analysis. It took less than 10 minutes to place this system on a subject and less than five seconds to analyze a jump.

Detailed Description:
This study will address the following specific aims: 1) To optimize a wearable, targeted, active training feedback device to reduce the risk of ACL injury among healthy subjects by inducing patterns of movement that alter the known kinematic and kinetic risk factors associated with ACL injuries. 2) To evaluate the efficacy of the active device and determine if the device reduces the risk of ACL injury among healthy subjects by effectively inducing patterns of movement that alter the known kinematic and kinetic risk factors associated with ACL injuries.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:The ages would range from 18 to 65. Both male and female subjects will be enrolled, and ethnic backgrounds would be mixed.

Exclusion Criteria:(i) chronic lower body pain (ii) recent surgery of the lower or upper body (limitation of range of motion) (iii) previous history of ligament, meniscal, or chondral injury requiring surgery to the lower limb (iv) inability to complete jumping tasks

  Contacts and Locations
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): NCT01021111


Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Thomas Peter Andriacchi Stanford University
  More Information

Responsible Party: Thomas Peter Andriacchi, Principle Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT01021111     History of Changes
Other Study ID Numbers: SU-09242009-4061
16584 ( Other Identifier: Stanford University Institutional Review Board )
First Submitted: November 24, 2009
First Posted: November 26, 2009
Results First Submitted: October 26, 2016
Results First Posted: April 21, 2017
Last Update Posted: April 21, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Wounds and Injuries
Knee Injuries
Athletic Injuries
Sprains and Strains
Leg Injuries