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

Primary Purpose

Injury of Anterior Cruciate Ligament

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
aNMT Biofeedback
Sham Biofeedback
Neuromuscular Training
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Injury of Anterior Cruciate Ligament focused on measuring ACL, biofeedback, injury prevention, virtual reality

Eligibility Criteria

12 Years - 18 Years (Child, Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • none

Sites / Locations

  • Emory Healthcare Sports Performance And Research Center (SPARC)
  • Cincinnati Childrens Hospital Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

aNMT Biofeedback

Sham Biofeedback

Arm Description

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

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

Outcomes

Primary Outcome Measures

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°.
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.
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).
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.
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.

Secondary Outcome Measures

Change in Post-training Lateral Trunk Flexion
Retention of effects of the intervention is assessed with lateral trunk flexion during the vertical drop task will be compared between study arms. Optimal lateral trunk flexion is 0°.environments compared to the sham feedback. The expected outcomes will support increased efficiency and enhanced efficacy of feedback for personalized and targeted injury prevention training.
Change in Post-training Knee to Hip Sagittal Plane Moment Ratio
Retention of effects of the intervention is assessed with 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.
Change in Post-training Knee Abduction Moment
Retention of effects of the intervention is assessed with knee abduction moment during the vertical drop task will be compared between study arms. Optimal knee abduction moment is ≤ 0 newton meter (Nm).
Change in Post-training Foot Placement
Retention of effects of the intervention is assessed with foot placement during the vertical drop task will be compared between study arms. Optimal foot placement is 1:1 ratio to hip width.
Change in Post-training Vertical Ground Reaction Force (VGRF) Ratio
Retention of effects of the intervention is assessed with VGRF during the vertical drop task will be compared between study arms. Optimal VGRF ratio is 1:1 ratio between limbs.

Full Information

First Posted
March 7, 2016
Last Updated
May 4, 2023
Sponsor
Emory University
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
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1. Study Identification

Unique Protocol Identification Number
NCT02933008
Brief Title
Real-time Sensorimotor Feedback for Injury Prevention Assessed in Virtual Reality
Official Title
Real-time Sensorimotor Feedback for Injury Prevention Assessed in Virtual Reality
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
December 2016 (Actual)
Primary Completion Date
May 9, 2022 (Actual)
Study Completion Date
May 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Augmented neuromuscular training (aNMT) integrates biomechanical screening with state-of-the-art augmented reality headsets to display real-time feedback that maps complex biomechanical variables onto simple visual feedback stimuli that athletes "control" via their own movements. The central hypothesis is that aNMT biofeedback will improve joint mechanics in evidence-based measures collected in realistic, sport-specific virtual reality scenarios. Specifically, the purpose of this investigation is to determine the efficacy of aNMT biofeedback to improve high-risk landing mechanics both in a laboratory task and during sport-specific scenarios. Based on the investigator's preliminary data, the investigators hypothesize that aNMT biofeedback will produce greater improvements in localized joint mechanics compared to neuromuscular training that incorporates sham feedback during the drop vertical jump (DVJ) task. In the secondary Aim, the investigators hypothesize aNMT will produce improved localized joint mechanics and global injury risk techniques during sport-specific maneuvers assessed in immersive virtual environments compared to the sham feedback. The expected outcomes will support increased efficiency and enhanced efficacy of feedback for personalized and targeted injury prevention training. The positive impact will be the improvement of injury risk mechanics and the potential to reduce injury on the field of play. A randomized, repeated-measures design will be used to test the two hypotheses for Aim 1: First, that aNMT will produce greater improvements in localized joint mechanics compared to the sham feedback group during the DVJ task; second, based on the preliminary data the investigators expect that innovative aNMT will lead to graduated joint improvements and reduced global injury risk mechanics that will exceed the overall task transferred reductions in high risk biomechanics following 12 real-time biofeedback training sessions. Previously described techniques will be used to measure biomechanical risk factors during a DVJ task performed at the beginning and end of the 6-week pre-competition training period. Athletes will be randomized into one of two groups: 1) aNMT biofeedback or (2) sham (augmented reality glasses with a stimulus that will provide exercise repetition count). Each athlete, as well as the statisticians, will be blinded to the intervention. All athletes will receive 12 training sessions over a 6-week period during their pre-competition season and each of the groups will have longitudinal assessment of biomechanical outcome measures captured at each biofeedback session. All participants will complete pre-training testing, 6 weeks of intervention, post-training testing, and post-season testing.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Injury of Anterior Cruciate Ligament
Keywords
ACL, biofeedback, injury prevention, virtual reality

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
420 (Actual)

8. Arms, Groups, and Interventions

Arm Title
aNMT Biofeedback
Arm Type
Experimental
Arm Description
Participants randomized to receive a neuromuscular training intervention that incorporates biofeedback training.
Arm Title
Sham Biofeedback
Arm Type
Sham Comparator
Arm Description
Participants randomized to receive a neuromuscular training intervention with sham feedback training.
Intervention Type
Other
Intervention Name(s)
aNMT Biofeedback
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Sham Biofeedback
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Neuromuscular Training
Intervention Description
Participants will complete a 12-week, pre-season training program, over 6 weeks.
Primary Outcome Measure Information:
Title
Change in Lateral Trunk Flexion
Description
Lateral trunk flexion during the vertical drop task will be compared between study arms. Optimal lateral trunk flexion is 0°.
Time Frame
Baseline (pre-training testing), Week 6 (post-training testing)
Title
Change in Knee to Hip Sagittal Plane Moment Ratio
Description
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.
Time Frame
Baseline (pre-training testing), Week 6 (post-training testing)
Title
Change in Knee Abduction Moment
Description
Knee abduction moment during the vertical drop task will be compared between study arms. Optimal knee abduction moment is ≤ 0 newton meter (Nm).
Time Frame
Baseline (pre-training testing), Week 6 (post-training testing)
Title
Change in Foot Placement
Description
Foot placement during the vertical drop task will be compared between study arms. Optimal foot placement is 1:1 ratio to hip width.
Time Frame
Baseline (pre-training testing), Week 6 (post-training testing)
Title
Change in Vertical Ground Reaction Force (VGRF) Ratio
Description
VGRF during the vertical drop task will be compared between study arms. Optimal VGRF ratio is 1:1 ratio between limbs.
Time Frame
Baseline (pre-training testing), Week 6 (post-training testing)
Secondary Outcome Measure Information:
Title
Change in Post-training Lateral Trunk Flexion
Description
Retention of effects of the intervention is assessed with lateral trunk flexion during the vertical drop task will be compared between study arms. Optimal lateral trunk flexion is 0°.environments compared to the sham feedback. The expected outcomes will support increased efficiency and enhanced efficacy of feedback for personalized and targeted injury prevention training.
Time Frame
Week 6 (post-training testing), up to Month 11 (post-season testing)
Title
Change in Post-training Knee to Hip Sagittal Plane Moment Ratio
Description
Retention of effects of the intervention is assessed with 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.
Time Frame
Week 6 (post-training testing), up to Month 11 (post-season testing)
Title
Change in Post-training Knee Abduction Moment
Description
Retention of effects of the intervention is assessed with knee abduction moment during the vertical drop task will be compared between study arms. Optimal knee abduction moment is ≤ 0 newton meter (Nm).
Time Frame
Week 6 (post-training testing), up to Month 11 (post-season testing)
Title
Change in Post-training Foot Placement
Description
Retention of effects of the intervention is assessed with foot placement during the vertical drop task will be compared between study arms. Optimal foot placement is 1:1 ratio to hip width.
Time Frame
Week 6 (post-training testing), up to Month 11 (post-season testing)
Title
Change in Post-training Vertical Ground Reaction Force (VGRF) Ratio
Description
Retention of effects of the intervention is assessed with VGRF during the vertical drop task will be compared between study arms. Optimal VGRF ratio is 1:1 ratio between limbs.
Time Frame
Week 6 (post-training testing), up to Month 11 (post-season testing)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: none
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory D Myer, PhD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory Healthcare Sports Performance And Research Center (SPARC)
City
Flowery Branch
State/Province
Georgia
ZIP/Postal Code
30542
Country
United States
Facility Name
Cincinnati Childrens Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
While study results will be published, individual subject data will not be shared with other researchers.

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

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