Real-time Sensorimotor Feedback for Injury Prevention Assessed in Virtual Reality

NCT02933008 | Completed DMC

• 3 other identifiers: STUDY000017705U01AR0679972014-2946
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 2

Brief Summary

Traumatic, debilitating anterior cruciate ligament (ACL) injuries occur at a 2 to 10-fold greater rate in female than male athletes. Consequently, there is a larger population of females that endure significant pain, functional limitations, and radiographic signs of knee osteoarthritis (OA) within 12 to 20 years following injury. To reduce the burden of OA, The National Public Health Agenda for Osteoarthritis recommends expanding and refining evidence-based prevention of ACL injury. Specialized training that targets modifiable risk factors shows statistical efficacy in high-risk athletes; however, clinically meaningful reduction of risk has not been achieved. A critical barrier that limits successful training outcomes is the requirement of qualified instructors to deliver personalized, intuitive, and accessible feedback to young athletes. Thus, a key gap in knowledge is how to efficiently deliver objective, effective feedback during training for injury prevention. The investigators long-term goal is to reduce ACL injuries and the subsequent sequela in young female athletes. The overall objective of this proposal is to implement and test innovative augmented neuromuscular training (aNMT) techniques to enhance sensorimotor learning and reduce biomechanical risk factors for ACL injury. The rationale that underlies this proposal is that, after completion, the investigators will be equipped to more effectively deliver biofeedback and decelerate the trend of increasing ACL injury rates in female athletes. This contribution will be significant for the reduction of the long-term sequel following ACL injury in young females.

Conditions

Injury of Anterior Cruciate Ligament

Keywords

ACL; biofeedback; injury prevention; virtual reality

Outcome Measures

Primary Outcomes (5)

• Change in Lateral Trunk Flexion

  Lateral trunk flexion during the vertical drop task will be compared between study arms. Optimal lateral trunk flexion is 0°.

  Baseline (pre-training testing), Week 6 (post-training testing)

• Change in Knee to Hip Sagittal Plane Moment Ratio

  Knee to hip sagittal plane moment ratio during the vertical drop task will be compared between study arms. Optimal knee to hip sagittal plane ratio is \< 1.

  Baseline (pre-training testing), Week 6 (post-training testing)

• Change in Knee Abduction Moment

  Knee abduction moment during the vertical drop task will be compared between study arms. Optimal knee abduction moment is ≤ 0 newton meter (Nm).

  Baseline (pre-training testing), Week 6 (post-training testing)

• Change in Foot Placement

  Foot placement during the vertical drop task will be compared between study arms. Optimal foot placement is 1:1 ratio to hip width.

  Baseline (pre-training testing), Week 6 (post-training testing)

• Change in Vertical Ground Reaction Force (VGRF) Ratio

  VGRF during the vertical drop task will be compared between study arms. Optimal VGRF ratio is 1:1 ratio between limbs.

  Baseline (pre-training testing), Week 6 (post-training testing)

Secondary Outcomes (5)

• Change in Post-training Lateral Trunk Flexion

  Week 6 (post-training testing), up to Month 11 (post-season testing)

• Change in Post-training Knee to Hip Sagittal Plane Moment Ratio

  Week 6 (post-training testing), up to Month 11 (post-season testing)

• Change in Post-training Knee Abduction Moment

  Week 6 (post-training testing), up to Month 11 (post-season testing)

• Change in Post-training Foot Placement

  Week 6 (post-training testing), up to Month 11 (post-season testing)

• Change in Post-training Vertical Ground Reaction Force (VGRF) Ratio

  Week 6 (post-training testing), up to Month 11 (post-season testing)

Study Arms (2)

aNMT Biofeedback

EXPERIMENTAL

Participants randomized to receive a neuromuscular training intervention that incorporates biofeedback training.

Other: aNMT Biofeedback; Other: Neuromuscular Training

Sham Biofeedback

SHAM COMPARATOR

Participants randomized to receive a neuromuscular training intervention with sham feedback training.

Other: Sham Biofeedback; Other: Neuromuscular Training

Interventions

aNMT Biofeedback OTHER

aNMT utilizes well-established visual feedback strategies to promote efficient, rapid and robust learning of complex movements. Athletes can discover how to move to create the desired feedback, even without explicit, conscious knowledge of how their movements relate to the visual pattern. aNMT biofeedback is created by calculating kinematic and kinetic data in real-time from the athlete's own movements. These values determine real-time transformations of the stimulus shape the athlete views via augmented-reality (AR) glasses during movement performance. The athlete's task is to move so as to create ("animate") a particular stimulus shape that corresponds to desired values of the biomechanical parameters targeted by the intervention.

aNMT Biofeedback

Sham Biofeedback OTHER

Sham biofeedback provides a similar phenomenological experience to aNMT biofeedback for athletes-both groups experience a shape that changes with their movements-but the sham biofeedback will not provide usable information to modify movement parameters during critical movement phases.

Sham Biofeedback

Neuromuscular Training OTHER

Participants will complete a 12-session, pre-season training program, over 6 weeks.

Sham Biofeedback; aNMT Biofeedback

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• intend to participate on an organized competitive sports team (volleyball, soccer, or basketball)
• be physically able to participate in their sport and complete the testing procedures at the time of study enrollment

You may not qualify if:

• none

Sponsors & Collaborators

• Emory University: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (2)

Emory Healthcare Sports Performance And Research Center (SPARC)

Flowery Branch, Georgia, 30542, United States

Location

Cincinnati Childrens Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Officials

• Gregory D Myer, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 7, 2016
• First Posted: October 14, 2016
• Study Start: December 1, 2016
• Primary Completion: May 9, 2022
• Study Completion: May 30, 2022
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)