Trial Outcomes & Findings for Neuroplastic Mechanisms Underlying Augmented Neuromuscular Training (NCT NCT04069520)
NCT ID: NCT04069520
Last Updated: 2024-07-25
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
93 participants
Primary outcome timeframe
Baseline (pre-training testing), Week 7 (post-training testing)
Results posted on
2024-07-25
Participant Flow
Participant milestones
| Measure |
aNMT Biofeedback
Participants randomized to receive a neuromuscular training intervention that incorporates aNMT biofeedback training.
aNMT Biofeedback: 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.
|
Sham Biofeedback
Participants randomized to receive a neuromuscular training intervention with sham feedback training.
Sham Biofeedback: 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.
|
|---|---|---|
|
Overall Study
STARTED
|
48
|
45
|
|
Overall Study
COMPLETED
|
46
|
40
|
|
Overall Study
NOT COMPLETED
|
2
|
5
|
Reasons for withdrawal
| Measure |
aNMT Biofeedback
Participants randomized to receive a neuromuscular training intervention that incorporates aNMT biofeedback training.
aNMT Biofeedback: 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.
|
Sham Biofeedback
Participants randomized to receive a neuromuscular training intervention with sham feedback training.
Sham Biofeedback: 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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Prior Injury
|
1
|
0
|
|
Overall Study
Orthodontia
|
1
|
0
|
|
Overall Study
Cut from team
|
0
|
2
|
Baseline Characteristics
Neuroplastic Mechanisms Underlying Augmented Neuromuscular Training
Baseline characteristics by cohort
| Measure |
aNMT Biofeedback
n=48 Participants
Female basketball, soccer and volleyball player enrolled in high school or club teams were randomized to receive a neuromuscular training intervention that incorporates biofeedback training.
|
Sham Biofeedback
n=45 Participants
Female basketball, soccer and volleyball players enrolled in high school or club teams were randomized to receive a neuromuscular training intervention that incorporates Sham biofeedback training.
|
Total
n=93 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
15.39 years
STANDARD_DEVIATION 1.22 • n=5 Participants
|
15.55 years
STANDARD_DEVIATION 1.30 • n=7 Participants
|
15.47 years
STANDARD_DEVIATION 1.47 • n=5 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
48 participants
n=5 Participants
|
45 participants
n=7 Participants
|
93 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (pre-training testing), Week 7 (post-training testing)Population: Number of participants at week 7 post-training includes subjects that were able to attend and complete the visit.
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.
Outcome measures
| Measure |
aNMT Biofeedback
n=48 Participants
Participants randomized to receive a neuromuscular training intervention that incorporates aNMT biofeedback training.
aNMT Biofeedback: 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.
|
Sham Biofeedback
n=45 Participants
Participants randomized to receive a neuromuscular training intervention with sham feedback training.
Sham Biofeedback: 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.
|
|---|---|---|
|
Neural Mechanisms for Injury-resistant Movement Pattern Acquisition
Baseline (pre-training testing)
|
0.28 % BOLD Signal change
Standard Deviation 0.11
|
0.26 % BOLD Signal change
Standard Deviation 0.17
|
|
Neural Mechanisms for Injury-resistant Movement Pattern Acquisition
Week 7 (post-training testing)
|
0.26 % BOLD Signal change
Standard Deviation 0.17
|
0.21 % BOLD Signal change
Standard Deviation 0.10
|
PRIMARY outcome
Timeframe: Baseline (pre-training testing), Week 7 (post-training testing)Population: Number of participants at week 7 post-training includes subjects that were able to attend and complete the visit.
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.
Outcome measures
| Measure |
aNMT Biofeedback
n=48 Participants
Participants randomized to receive a neuromuscular training intervention that incorporates aNMT biofeedback training.
aNMT Biofeedback: 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.
|
Sham Biofeedback
n=45 Participants
Participants randomized to receive a neuromuscular training intervention with sham feedback training.
Sham Biofeedback: 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.
|
|---|---|---|
|
Knee Joint Biomechanics During Landing Task
Knee angle at Baseline (pre-training testing)
|
83.49 Degrees
Standard Deviation 10.00
|
80.50 Degrees
Standard Deviation 9.77
|
|
Knee Joint Biomechanics During Landing Task
Knee angle at Week 7 (post-training testing)
|
86.06 Degrees
Standard Deviation 10.81
|
83.48 Degrees
Standard Deviation 10.36
|
SECONDARY outcome
Timeframe: Baseline (pre-training testing), Week 7 (post-training testing)Population: Number of participants at week 7 post-training includes subjects that were able to attend and complete the visit.
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.
Outcome measures
| Measure |
aNMT Biofeedback
n=48 Participants
Participants randomized to receive a neuromuscular training intervention that incorporates aNMT biofeedback training.
aNMT Biofeedback: 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.
|
Sham Biofeedback
n=45 Participants
Participants randomized to receive a neuromuscular training intervention with sham feedback training.
Sham Biofeedback: 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.
|
|---|---|---|
|
Neural Mechanisms for Injury-resistant Movement Pattern Transfer to VR-simulated Sport
Baseline (pre-training testing)
|
0.31 % of BOLD signal change
Standard Deviation 0.14
|
0.26 % of BOLD signal change
Standard Deviation 0.13
|
|
Neural Mechanisms for Injury-resistant Movement Pattern Transfer to VR-simulated Sport
Week 7 (post-training testing)
|
0.26 % of BOLD signal change
Standard Deviation 0.13
|
0.31 % of BOLD signal change
Standard Deviation 0.11
|
SECONDARY outcome
Timeframe: Baseline (pre-training testing), Week 7 (post-training testing)Population: Number of participants at week 7 post-training includes subjects that were able to attend and complete the visit.
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.
Outcome measures
| Measure |
aNMT Biofeedback
n=48 Participants
Participants randomized to receive a neuromuscular training intervention that incorporates aNMT biofeedback training.
aNMT Biofeedback: 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.
|
Sham Biofeedback
n=45 Participants
Participants randomized to receive a neuromuscular training intervention with sham feedback training.
Sham Biofeedback: 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.
|
|---|---|---|
|
Knee Joint Biomechanics During VR-simulated Sport
Knee angle at Baseline (pre-training testing)
|
68.43 Degrees
Standard Deviation 10.93
|
68.93 Degrees
Standard Deviation 12.10
|
|
Knee Joint Biomechanics During VR-simulated Sport
Knee angle at Week 7 (post-training testing)
|
73.27 Degrees
Standard Deviation 12.76
|
71.89 Degrees
Standard Deviation 12.09
|
Adverse Events
aNMT Biofeedback
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham Biofeedback
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place