NCT01021111

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 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

November 1, 2009

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

November 24, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 26, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
3.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

April 21, 2017

Completed
Last Updated

April 21, 2017

Status Verified

March 1, 2017

Enrollment Period

1.4 years

First QC Date

November 24, 2009

Results QC Date

October 26, 2016

Last Update Submit

March 15, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 day

Secondary Outcomes (1)

  • Thigh Coronal Angular Velocity After Feedback Training

    1 day

Study Arms (1)

Activity Training with Feedback

EXPERIMENTAL

Subject is tested prior to training and retested with feedback training designed to modify the mechanics of landing during jumping and running activities

Device: Activity Training with Feedback

Interventions

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.

Activity Training with Feedback

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Athletic InjuriesSprains and StrainsWounds and InjuriesKnee Injuries

Condition Hierarchy (Ancestors)

Leg Injuries

Results Point of Contact

Title
Professor Thomas P. Andriacchi
Organization
Stanford University

Study Officials

  • Thomas Peter Andriacchi

    Stanford University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

November 24, 2009

First Posted

November 26, 2009

Study Start

November 1, 2009

Primary Completion

April 1, 2011

Study Completion

December 1, 2014

Last Updated

April 21, 2017

Results First Posted

April 21, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations