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Trial record 13 of 346 for:    sprains and strains

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

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ClinicalTrials.gov Identifier: NCT01021111
Recruitment Status : Completed
First Posted : November 26, 2009
Results First Posted : April 21, 2017
Last Update Posted : April 21, 2017
Sponsor:
Information provided by (Responsible Party):
Thomas Peter Andriacchi, Stanford University

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
Enrollment 17
Recruitment Details 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  
Arm/Group Title Activity Training With Feedback
Hide Arm/Group Description

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

Period Title: Overall Study
Started 17
Completed 17
Not Completed 0
Arm/Group Title Activity Training With Feedback
Hide Arm/Group Description Subjects who underwent activity training with feedback
Overall Number of Baseline Participants 17
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants
27.5  (2.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants
Female
10
  58.8%
Male
7
  41.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 17 participants
17
Knee Flexion Angle  
Mean (Standard Deviation)
Unit of measure:  Degrees
Number Analyzed 17 participants
88.8  (8.0)
Trunk lean  
Mean (Standard Deviation)
Unit of measure:  Degrees
Number Analyzed 17 participants
23.6  (8.0)
Thigh coronal angular velocity  
Mean (Standard Deviation)
Unit of measure:  Degrees/second
Number Analyzed 17 participants
67.7  (49.7)
1.Primary Outcome
Title Knee Flexion Angle and Trunk Flexion Angle After Activity Training With Feedback
Hide Description 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.
Time Frame 1 day
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Activity Training With Feedback
Hide Arm/Group Description:
Subjects who underwent activity training with feedback
Overall Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: degrees
Knee Flexion Angle 105.0  (5.6)
Trunk Lean 41.0  (3.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Activity Training With Feedback
Comments The values from the three jumps were averaged in order to have one mean value per subject per session. Paired Student t-tests (baseline vs. follow-up) were used to evaluate the effects of the training.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Secondary Outcome
Title Thigh Coronal Angular Velocity After Feedback Training
Hide Description How fast the thigh is moving relative to the tibia during the activity, measured in degrees/second.
Time Frame 1 day
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Activity Training With Feedback
Hide Arm/Group Description:
Subjects who underwent activity training with feedback
Overall Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: degrees/second
47.6  (40.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Activity Training With Feedback
Comments The association between the change in the thigh coronal angular velocity from baseline to follow-up and the change in the knee abduction moment from baseline to follow-up was assessed with the Pearson correlation coefficient (R), alpha =0.05
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Pearson
Comments [Not Specified]
Time Frame 1 day
Adverse Event Reporting Description Adverse events were monitored on the day of subject testing
 
Arm/Group Title Activity Training With Feedback
Hide Arm/Group Description

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

All-Cause Mortality
Activity Training With Feedback
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Activity Training With Feedback
Affected / at Risk (%)
Total   0/17 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Activity Training With Feedback
Affected / at Risk (%)
Total   0/17 (0.00%) 
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
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 )
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