Neuroplastic Mechanisms Underlying Augmented Neuromuscular Training

NCT04069520 | Completed Results

• 3 other identifiers: STUDY000017721R01AR0761532019-0245
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to determine the neural mechanisms of augmented neuromuscular training (aNMT). Participants will complete a 6-week course of neuromuscular training with either aNMT biofeedback or sham biofeedback. An MRI will be performed before and after the training program.

Conditions

Anterior Cruciate Ligament Injuries

Outcome Measures

Primary Outcomes (2)

• Neural Mechanisms for Injury-resistant Movement Pattern Acquisition

  Sensorimotor brain activity was measured in task-based fMRI (% Blood Oxygen Level Dependent (BOLD) Signal change of knee sensorimotor network regions from baseline between rest and move blocks at each respective time point- the standard measure to determine brain activity during a condition is to contrast to rest to remove confounds make the data interpretable across conditions and individuals) and was associated with knee joint biomechanics (knee sagittal and frontal plane angle and moments) captured during landing task during standard laboratory landing assessment pre- and post-intervention.

  Baseline (pre-training testing), Week 7 (post-training testing)

• Knee Joint Biomechanics During Landing Task

  Knee joint biomechanics (knee angle) captured during a standard laboratory landing task assessment was reported pre- and post-intervention. The degree of knee angle is the peak knee flexion angle during drop vertical jump landing.

  Baseline (pre-training testing), Week 7 (post-training testing)

Secondary Outcomes (2)

• Neural Mechanisms for Injury-resistant Movement Pattern Transfer to VR-simulated Sport

  Baseline (pre-training testing), Week 7 (post-training testing)

• Knee Joint Biomechanics During VR-simulated Sport

  Baseline (pre-training testing), Week 7 (post-training testing)

Study Arms (2)

aNMT Biofeedback

EXPERIMENTAL

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

Other: aNMT Biofeedback

Sham Biofeedback

SHAM COMPARATOR

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

Other: Sham Biofeedback

Interventions

aNMT Biofeedback OTHER

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. The aNMT biofeedback occurs during neuromuscular training sessions. The neuromuscular training is a 18 session, pre-season training program occurring over 6 weeks.

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. The sham biofeedback occurs during neuromuscular training sessions. The neuromuscular training is a 18 session, pre-season training program occurring over 6 weeks.

Sham Biofeedback

Eligibility Criteria

• Age: 12 Years - 19 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \- enrolled in parent study "Real-time Sensorimotor Feedback for Injury Prevention Assessed in Virtual Reality"

You may not qualify if:

• \- contraindications to MRI scan

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 (CCHMC)

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Results Point of Contact

• Title: Dr. Kim Barber Foss
• Organization: Emory University

kim.barberfoss@emory.edu

404-544-1306

Study Officials

• Gregory D Myer, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: July 9, 2019
• First Posted: August 28, 2019
• Study Start: June 1, 2019
• Primary Completion: August 3, 2021
• Study Completion: August 3, 2021
• Last Updated: July 25, 2024
• Results First Posted: July 25, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)