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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:
Information provided by (Responsible Party):
Thomas Peter Andriacchi, Stanford University
ClinicalTrials.gov Identifier:
NCT01021111
First received: November 24, 2009
Last updated: March 15, 2017
Last verified: March 2017
Results First Received: October 26, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions: Athletic Injuries
Sprains and Strains
Wounds and Injuries
Knee Injuries
Intervention: Device: Activity Training with Feedback

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were involved in sports involving jumping maneuvers at the recreational level and free of previous lower limb musculoskeletal injuries, surgery, or pain. Subjects were unaware of the goals of the study prior to the start of the testing session.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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

Anterior Cruciate Ligament Measurement and Feedback System


Participant Flow:   Overall Study
    Activity Training With Feedback
STARTED   17 
COMPLETED   17 
NOT COMPLETED   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Activity Training With Feedback Subjects who underwent activity training with feedback

Baseline Measures
   Activity Training With Feedback 
Overall Participants Analyzed 
[Units: Participants]
 17 
Age 
[Units: Years]
Mean (Standard Deviation)
 27.5  (2.3) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      10  58.8% 
Male      7  41.2% 
Region of Enrollment 
[Units: Participants]
 
United States   17 
Knee Flexion Angle 
[Units: Degrees]
Mean (Standard Deviation)
 88.8  (8.0) 
Trunk lean 
[Units: Degrees]
Mean (Standard Deviation)
 23.6  (8.0) 
Thigh coronal angular velocity 
[Units: Degrees/second]
Mean (Standard Deviation)
 67.7  (49.7) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Knee Flexion Angle and Trunk Flexion Angle After Activity Training With Feedback   [ Time Frame: 1 day ]

2.  Secondary:   Thigh Coronal Angular Velocity After Feedback Training   [ Time Frame: 1 day ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Professor Thomas P. Andriacchi
Organization: Stanford University
phone: 6507238024
e-mail: tandriac@stanford.edu



Responsible Party: Thomas Peter Andriacchi, Stanford University
ClinicalTrials.gov Identifier: NCT01021111     History of Changes
Other Study ID Numbers: SU-09242009-4061
16584 ( Other Identifier: Stanford University Institutional Review Board )
Study First Received: November 24, 2009
Results First Received: October 26, 2016
Last Updated: March 15, 2017