NCT01034527

Brief Summary

Females who participate in cutting and landing sports suffer anterior cruciate ligament (ACL) injuries at a 2 to 10-fold greater rate than males participating in the same high-risk sports. Fifty to 100 percent of ACL injured females will suffer osteoarthritis of the injured knee within one to two decades of the injury. External knee abduction moment (LOAD) predicts ACL injury with high sensitivity and specificity in female athletes. Control of lateral trunk motion (LTM) also predicts ACL injury with similar levels of sensitivity and specificity in female athletes. These predictors may be linked, as lateral positioning of the trunk can create high knee abduction load via both biomechanical and neuromuscular mechanisms. The mechanism of ACL injury in females include high knee LOAD and high LTM, with the majority of body weight shifted over the injured limb and the foot positioned lateral to the body's center of mass. An unanticipated perturbation is also often a contributor to the injury mechanism. LTM may result in increased knee LOAD by increasing the lateral position and magnitude of the GRF vector (ΔGRFv) or by increasing reactive hip adductor torque (HAdT). Our long-term objectives are to determine the mechanisms that cause ACL injury in female athletes and to develop neuromuscular training (NMT) interventions that specifically target these mechanisms. If the objectives of this proposal are achieved, an evidence-based NMT intervention will be developed and made available nationally that will effectively and efficiently reduce ACL injury risk in high-risk female athletes. The major goal of this proposal is to determine if increased LTM increases coronal plane knee load in high-risk groups of female athletes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
593

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 16, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 17, 2009

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
6.2 years until next milestone

Results Posted

Study results publicly available

July 30, 2019

Completed
Last Updated

September 4, 2020

Status Verified

August 1, 2020

Enrollment Period

4 years

First QC Date

December 16, 2009

Results QC Date

January 10, 2017

Last Update Submit

August 20, 2020

Conditions

Keywords

Anterior Cruciate LigamentFemale AthleteSports InjuriesInjury Prevention

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Decrease in Knee Valgus Measurement

    determine biomechanical risk factors for ACL injury and determine if participation in NMT reduces risk factors compared to sham (speed training)

    2 years

Study Arms (2)

Neuromuscular Training

EXPERIMENTAL

Combination of exercises and phases designed to initiate lateral trunk perturbations that force the athlete to decelerate and control the trunk in order to successfully perform the techniques.

Other: Neuromuscular Training

Speed Training

NO INTERVENTION

Sham training will consist of sagittal plane only running drills designs solely to enhance sprint speed. A sham sagittal plane sprint training protocol that will be instituted with the teams that are randomly selected for sham treatment. Five phases will be utilized to facilitate progressions designed to improve the athletes' forward sprinting speed. Training volume will be approximately equivalent for the TNMT and sham protocols. They each will take athletes approximately 30 minutes to complete

Interventions

Combination of exercises and phases to initiate lateral trunk perturbations that force the athlete to decelerate and control the trunk in order to successfully perform the techniques.

Neuromuscular Training

Eligibility Criteria

Age10 Years - 19 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Female
  • Soccer, Basketball, or Volleyball athlete
  • Attends Middle School or High School in Boone County or Fayette County KY

You may not qualify if:

  • Male

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45206, United States

Location

Related Publications (1)

  • Hewett TE, Ford KR, Xu YY, Khoury J, Myer GD. Utilization of ACL Injury Biomechanical and Neuromuscular Risk Profile Analysis to Determine the Effectiveness of Neuromuscular Training. Am J Sports Med. 2016 Dec;44(12):3146-3151. doi: 10.1177/0363546516656373. Epub 2016 Jul 29.

MeSH Terms

Conditions

Anterior Cruciate Ligament InjuriesAthletic Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Results Point of Contact

Title
Dr. Timothy Hewett
Organization
Mayo Clinic

Study Officials

  • Timothy E Hewett, Phd

    Children's Hospital Medical Center, Cincinnati

    PRINCIPAL INVESTIGATOR
  • Kim D Barber Foss, MS

    Children's Hospital Medical Center, Cincinnati

    STUDY DIRECTOR
  • Staci Thomas, Ms

    Children's Hospital Medical Center, Cincinnati

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2009

First Posted

December 17, 2009

Study Start

June 1, 2009

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

September 4, 2020

Results First Posted

July 30, 2019

Record last verified: 2020-08

Locations