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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01021111
First received: November 24, 2009
Last updated: June 11, 2013
Last verified: June 2013
  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. 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.


Condition Intervention Phase
Athletic Injuries
Sprains and Strains
Wounds and Injuries
Knee Injuries
Device: Anterior Cruciate Ligament Measurement and Feedback System
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Design and Evaluation of an Active Intervention for the Prevention of Non-contact ACL Injury

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Decrease in risk for ACL injury [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Patient safety during use of intervention [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change in knee kinematics [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: November 2009
Estimated Study Completion Date: December 2013
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: Anterior Cruciate Ligament Measurement and Feedback System

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01021111     History of Changes
Other Study ID Numbers: SU-09242009-4061, 16584
Study First Received: November 24, 2009
Last Updated: June 11, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 27, 2014