Trial Outcomes & Findings for The Design and Evaluation of an Active Intervention for the Prevention of Non-contact ACL Injury (NCT NCT01021111)

NCT ID: NCT01021111

Last Updated: 2017-04-21

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 17 participants
• Primary outcome timeframe: 1 day
• Results posted on: 2017-04-21

Participant Flow

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.

Participant milestones

Measure	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
Overall Study STARTED	17
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Activity Training With Feedback n=17 Participants Subjects who underwent activity training with feedback
Age, Continuous	27.5 years STANDARD_DEVIATION 2.3 • n=93 Participants
Sex: Female, Male Female	10 Participants n=93 Participants
Sex: Female, Male Male	7 Participants n=93 Participants
Region of Enrollment United States	17 participants n=93 Participants
Knee Flexion Angle	88.8 degrees STANDARD_DEVIATION 8.0 • n=93 Participants
Trunk lean	23.6 degrees STANDARD_DEVIATION 8.0 • n=93 Participants
Thigh coronal angular velocity	67.7 degrees/second STANDARD_DEVIATION 49.7 • n=93 Participants

PRIMARY outcome

Timeframe: 1 day

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.

Outcome measures

Measure	Activity Training With Feedback n=17 Participants Subjects who underwent activity training with feedback
Knee Flexion Angle and Trunk Flexion Angle After Activity Training With Feedback Knee Flexion Angle	105.0 degrees Standard Deviation 5.6
Knee Flexion Angle and Trunk Flexion Angle After Activity Training With Feedback Trunk Lean	41.0 degrees Standard Deviation 3.8

SECONDARY outcome

Timeframe: 1 day

How fast the thigh is moving relative to the tibia during the activity, measured in degrees/second.

Outcome measures

Measure	Activity Training With Feedback n=17 Participants Subjects who underwent activity training with feedback
Thigh Coronal Angular Velocity After Feedback Training	47.6 degrees/second Standard Deviation 40.5

Adverse Events

Activity Training With Feedback

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Professor Thomas P. Andriacchi

Stanford University

Phone: 6507238024

Email: tandriac@stanford.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place