NCT04069520

Neuroplastic Mechanisms Underlying Augmented Neuromuscular Training

Completed NA Results posted Last updated 25 July 2024

What this trial tests

NA trial testing aNMT Biofeedback in Anterior Cruciate Ligament Injuries in 93 participants. Completed in 3 August 2021.

Timeline

1 June 2019

Primary endpoint
3 August 2021

3 August 2021

Quick facts

Lead sponsor	Emory University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	93
Start date	1 June 2019
Primary completion	3 August 2021
Estimated completion	3 August 2021
Sites	2 locations across United States

Drugs / interventions tested

• aNMT Biofeedback
• Sham Biofeedback

Conditions studied

• Anterior Cruciate Ligament Injuries — all drugs for Anterior Cruciate Ligament Injuries →

Sponsor

Emory University

Who can join

Adults 12 to 19, female only, with Anterior Cruciate Ligament Injuries. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Neural Mechanisms for Injury-resistant Movement Pattern Acquisition Primary · Baseline (pre-training testing), Week 7 (post-training testing)

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)

Group	Value	95% CI
aNMT Biofeedback	0.28	± 0.11
Sham Biofeedback	0.26	± 0.17

Week 7 (post-training testing)

Group	Value	95% CI
aNMT Biofeedback	0.26	± 0.17
Sham Biofeedback	0.21	± 0.10

Knee Joint Biomechanics During Landing Task Primary · Baseline (pre-training testing), Week 7 (post-training testing)

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.

Knee angle at Baseline (pre-training testing)

Group	Value	95% CI
aNMT Biofeedback	83.49	± 10.00
Sham Biofeedback	80.50	± 9.77

Knee angle at Week 7 (post-training testing)

Group	Value	95% CI
aNMT Biofeedback	86.06	± 10.81
Sham Biofeedback	83.48	± 10.36

Neural Mechanisms for Injury-resistant Movement Pattern Transfer to VR-simulated Sport Secondary · Baseline (pre-training testing), Week 7 (post-training testing)

Sensorimotor brain activity during 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) was assessed and compared to biomechanical movement patterns (knee angle) measured during VR-simulated sport.

Baseline (pre-training testing)

Group	Value	95% CI
aNMT Biofeedback	0.31	± 0.14
Sham Biofeedback	0.26	± 0.13

Week 7 (post-training testing)

Group	Value	95% CI
aNMT Biofeedback	0.26	± 0.13
Sham Biofeedback	0.31	± 0.11

Knee Joint Biomechanics During VR-simulated Sport Secondary · Baseline (pre-training testing), Week 7 (post-training testing)

Biomechanical movement patterns (knee angle) were measured during VR-simulated sport at pre- and post-intervention. The degree of knee angle is the peak knee flexion angle during a sport specific landing task.

Knee angle at Baseline (pre-training testing)

Group	Value	95% CI
aNMT Biofeedback	68.43	± 10.93
Sham Biofeedback	68.93	± 12.10

Knee angle at Week 7 (post-training testing)

Group	Value	95% CI
aNMT Biofeedback	73.27	± 12.76
Sham Biofeedback	71.89	± 12.09

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.