Back to resultsThe Design and Evaluation of an Active Intervention for the Prevention of Non-contact ACL Injury
Primary Purpose
Athletic Injuries, Sprains and Strains, Wounds and Injuries
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Activity Training with Feedback
Sponsored by
About this trial
This is an interventional prevention trial for Athletic Injuries
Eligibility 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
Sites / Locations
- Stanford University School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Activity Training with Feedback
Arm Description
Subject is tested prior to training and retested with feedback training designed to modify the mechanics of landing during jumping and running activities
Outcomes
Primary Outcome Measures
Knee Flexion Angle and Trunk Flexion Angle After Activity Training With Feedback
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
How fast the thigh is moving relative to the tibia during the activity, measured in degrees/second.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01021111
Brief Title
The Design and Evaluation of an Active Intervention for the Prevention of Non-contact ACL Injury
Official Title
The Design and Evaluation of an Active Intervention for the Prevention of Non-contact ACL Injury
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Athletic Injuries, Sprains and Strains, Wounds and Injuries, Knee Injuries
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Activity Training with Feedback
Arm Type
Experimental
Arm Description
Subject is tested prior to training and retested with feedback training designed to modify the mechanics of landing during jumping and running activities
Intervention Type
Device
Intervention Name(s)
Activity Training with Feedback
Intervention Description
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.
Primary Outcome Measure Information:
Title
Knee Flexion Angle and Trunk Flexion Angle After Activity Training With Feedback
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
Secondary Outcome Measure Information:
Title
Thigh Coronal Angular Velocity After Feedback Training
Description
How fast the thigh is moving relative to the tibia during the activity, measured in degrees/second.
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Peter Andriacchi
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Design and Evaluation of an Active Intervention for the Prevention of Non-contact ACL Injury
We'll reach out to this number within 24 hrs