Trial Outcomes & Findings for Reduction of Risk Factors for ACL Re-injuries Using a Novel Biofeedback Approach (NCT NCT03273673)
NCT ID: NCT03273673
Last Updated: 2020-12-04
Results Overview
The peak knee extension moment asymmetry will be assessed during the first landing of a stop-jump task
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
Baseline (week 0) and Post-intervention (week 6)
Results posted on
2020-12-04
Participant Flow
Participant milestones
| Measure |
Biofeedback Intervention
The 6-week biofeedback training program is focused on altering loading and movement asymmetry during biweekly sessions on non-consecutive days (12 sessions). The biofeedback training program will provide sensory (visual and tactile) feedback to the subject to heighten awareness of asymmetrical movement strategies (e.g. load shift, movement asymmetry) during a squat. The two exercises that will be completed during the biofeedback training program will be a visual feedback squat and a resisted squat (tactile feedback). Each of these tasks will be completed 30 (3 sets of 10 repetitions) times per session. We will provide a 20 second rest between trials, and a 10 minute break between the visual and tactile feedback exercises to decrease the effect of fatigue.
Biofeedback Intervention: Visual and Tactile Biofeedback
|
Control
The 6-week attention control group program will focus on providing educational information to the participants related to the clinical and sports expectations as they are released to return to sport. These participants will be asked to meet 6 times during the 6-week intervention time period. Three of these visits will be completed in person and three will be completed using an online educational module (6 sessions). The online sessions will be completed in week 1, week 3, and week 5 while the in person sessions will be completed during week 2, week 4, and week 6.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
22
|
|
Overall Study
COMPLETED
|
14
|
22
|
|
Overall Study
NOT COMPLETED
|
4
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Reduction of Risk Factors for ACL Re-injuries Using a Novel Biofeedback Approach
Baseline characteristics by cohort
| Measure |
Biofeedback Intervention
n=18 Participants
The 6-week biofeedback training program is focused on altering loading and movement asymmetry during biweekly sessions on non-consecutive days (12 sessions). The biofeedback training program will provide sensory (visual and tactile) feedback to the subject to heighten awareness of asymmetrical movement strategies (e.g. load shift, movement asymmetry) during a squat. The two exercises that will be completed during the biofeedback training program will be a visual feedback squat and a resisted squat (tactile feedback). Each of these tasks will be completed 30 (3 sets of 10 repetitions) times per session. We will provide a 20 second rest between trials, and a 10 minute break between the visual and tactile feedback exercises to decrease the effect of fatigue.
Biofeedback Intervention: Visual and Tactile Biofeedback
|
Control
n=22 Participants
The 6-week attention control group program will focus on providing educational information to the participants related to the clinical and sports expectations as they are released to return to sport. These participants will be asked to meet 6 times during the 6-week intervention time period. Three of these visits will be completed in person and three will be completed using an online educational module (6 sessions). The online sessions will be completed in week 1, week 3, and week 5 while the in person sessions will be completed during week 2, week 4, and week 6.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
16.2 years
STANDARD_DEVIATION 1.6 • n=5 Participants
|
16.4 years
STANDARD_DEVIATION 2.2 • n=7 Participants
|
16.3 years
STANDARD_DEVIATION 1.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=5 Participants
|
22 participants
n=7 Participants
|
40 participants
n=5 Participants
|
|
Peak Knee Extension Moment Symmetry
|
47.9 % Symmetry
STANDARD_DEVIATION 28.4 • n=5 Participants
|
41.4 % Symmetry
STANDARD_DEVIATION 16.3 • n=7 Participants
|
44.3 % Symmetry
STANDARD_DEVIATION 22.5 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (week 0) and Post-intervention (week 6)Population: Analysis completed with participants with \>80% adherence
The peak knee extension moment asymmetry will be assessed during the first landing of a stop-jump task
Outcome measures
| Measure |
Biofeedback Intervention
n=11 Participants
The 6-week biofeedback training program is focused on altering loading and movement asymmetry during biweekly sessions on non-consecutive days (12 sessions). The biofeedback training program will provide sensory (visual and tactile) feedback to the subject to heighten awareness of asymmetrical movement strategies (e.g. load shift, movement asymmetry) during a squat. The two exercises that will be completed during the biofeedback training program will be a visual feedback squat and a resisted squat (tactile feedback). Each of these tasks will be completed 30 (3 sets of 10 repetitions) times per session. We will provide a 20 second rest between trials, and a 10 minute break between the visual and tactile feedback exercises to decrease the effect of fatigue.
Biofeedback Intervention: Visual and Tactile Biofeedback
|
Control
n=19 Participants
The 6-week attention control group program will focus on providing educational information to the participants related to the clinical and sports expectations as they are released to return to sport. These participants will be asked to meet 6 times during the 6-week intervention time period. Three of these visits will be completed in person and three will be completed using an online educational module (6 sessions). The online sessions will be completed in week 1, week 3, and week 5 while the in person sessions will be completed during week 2, week 4, and week 6.
|
|---|---|---|
|
Change in Peak Knee Extension Moment Symmetry
Baseline
|
50.1 % Symmetry
Standard Deviation 33.8
|
44.2 % Symmetry
Standard Deviation 26
|
|
Change in Peak Knee Extension Moment Symmetry
Post-intervention
|
44.6 % Symmetry
Standard Deviation 24.2
|
40.6 % Symmetry
Standard Deviation 16.7
|
PRIMARY outcome
Timeframe: Post-intervention (week 6) and Retention (week 12)Population: Analysis completed with participants with \>80% adherence
The peak knee extension moment asymmetry will be assessed during the first landing of a stop-jump task
Outcome measures
| Measure |
Biofeedback Intervention
n=14 Participants
The 6-week biofeedback training program is focused on altering loading and movement asymmetry during biweekly sessions on non-consecutive days (12 sessions). The biofeedback training program will provide sensory (visual and tactile) feedback to the subject to heighten awareness of asymmetrical movement strategies (e.g. load shift, movement asymmetry) during a squat. The two exercises that will be completed during the biofeedback training program will be a visual feedback squat and a resisted squat (tactile feedback). Each of these tasks will be completed 30 (3 sets of 10 repetitions) times per session. We will provide a 20 second rest between trials, and a 10 minute break between the visual and tactile feedback exercises to decrease the effect of fatigue.
Biofeedback Intervention: Visual and Tactile Biofeedback
|
Control
n=22 Participants
The 6-week attention control group program will focus on providing educational information to the participants related to the clinical and sports expectations as they are released to return to sport. These participants will be asked to meet 6 times during the 6-week intervention time period. Three of these visits will be completed in person and three will be completed using an online educational module (6 sessions). The online sessions will be completed in week 1, week 3, and week 5 while the in person sessions will be completed during week 2, week 4, and week 6.
|
|---|---|---|
|
Change in Peak Knee Extension Moment Symmetry
Post-intervention
|
44.6 % Symmetry
Standard Deviation 24.2
|
40.6 % Symmetry
Standard Deviation 16.7
|
|
Change in Peak Knee Extension Moment Symmetry
Retention
|
38.7 % Symmetry
Standard Deviation 22.5
|
33.3 % Symmetry
Standard Deviation 13.5
|
SECONDARY outcome
Timeframe: Baseline (week 0) and Post-intervention (week 6)Population: Analysis completed with participants with \>80% adherence
The frontal plane knee range of motion will be assessed during the first landing of a stop-jump task
Outcome measures
| Measure |
Biofeedback Intervention
n=11 Participants
The 6-week biofeedback training program is focused on altering loading and movement asymmetry during biweekly sessions on non-consecutive days (12 sessions). The biofeedback training program will provide sensory (visual and tactile) feedback to the subject to heighten awareness of asymmetrical movement strategies (e.g. load shift, movement asymmetry) during a squat. The two exercises that will be completed during the biofeedback training program will be a visual feedback squat and a resisted squat (tactile feedback). Each of these tasks will be completed 30 (3 sets of 10 repetitions) times per session. We will provide a 20 second rest between trials, and a 10 minute break between the visual and tactile feedback exercises to decrease the effect of fatigue.
Biofeedback Intervention: Visual and Tactile Biofeedback
|
Control
n=19 Participants
The 6-week attention control group program will focus on providing educational information to the participants related to the clinical and sports expectations as they are released to return to sport. These participants will be asked to meet 6 times during the 6-week intervention time period. Three of these visits will be completed in person and three will be completed using an online educational module (6 sessions). The online sessions will be completed in week 1, week 3, and week 5 while the in person sessions will be completed during week 2, week 4, and week 6.
|
|---|---|---|
|
Change in Frontal Plane Knee Range of Motion
Baseline
|
6.4 Degree
Standard Deviation 2.7
|
10.1 Degree
Standard Deviation 4.4
|
|
Change in Frontal Plane Knee Range of Motion
Post-Intervention
|
7.5 Degree
Standard Deviation 4.5
|
9.1 Degree
Standard Deviation 4.3
|
SECONDARY outcome
Timeframe: Post-intervention (week 6) and Retention (week 12)Population: Analysis completed with participants with \>80% adherence
The frontal plane knee range of motion will be assessed during the first landing of a stop-jump task
Outcome measures
| Measure |
Biofeedback Intervention
n=11 Participants
The 6-week biofeedback training program is focused on altering loading and movement asymmetry during biweekly sessions on non-consecutive days (12 sessions). The biofeedback training program will provide sensory (visual and tactile) feedback to the subject to heighten awareness of asymmetrical movement strategies (e.g. load shift, movement asymmetry) during a squat. The two exercises that will be completed during the biofeedback training program will be a visual feedback squat and a resisted squat (tactile feedback). Each of these tasks will be completed 30 (3 sets of 10 repetitions) times per session. We will provide a 20 second rest between trials, and a 10 minute break between the visual and tactile feedback exercises to decrease the effect of fatigue.
Biofeedback Intervention: Visual and Tactile Biofeedback
|
Control
n=19 Participants
The 6-week attention control group program will focus on providing educational information to the participants related to the clinical and sports expectations as they are released to return to sport. These participants will be asked to meet 6 times during the 6-week intervention time period. Three of these visits will be completed in person and three will be completed using an online educational module (6 sessions). The online sessions will be completed in week 1, week 3, and week 5 while the in person sessions will be completed during week 2, week 4, and week 6.
|
|---|---|---|
|
Change in Frontal Plane Knee Range of Motion
Post-intervention
|
7.5 Degree
Standard Deviation 4.5
|
9.1 Degree
Standard Deviation 4.3
|
|
Change in Frontal Plane Knee Range of Motion
Retention
|
7.9 Degree
Standard Deviation 4.2
|
10.1 Degree
Standard Deviation 4.6
|
SECONDARY outcome
Timeframe: Baseline (week 0) and Post-intervention (week 6)Population: Analysis completed with participants with \>80% adherence
The peak vertical ground reaction force symmetry will be assessed during the first landing of a stop-jump task
Outcome measures
| Measure |
Biofeedback Intervention
n=11 Participants
The 6-week biofeedback training program is focused on altering loading and movement asymmetry during biweekly sessions on non-consecutive days (12 sessions). The biofeedback training program will provide sensory (visual and tactile) feedback to the subject to heighten awareness of asymmetrical movement strategies (e.g. load shift, movement asymmetry) during a squat. The two exercises that will be completed during the biofeedback training program will be a visual feedback squat and a resisted squat (tactile feedback). Each of these tasks will be completed 30 (3 sets of 10 repetitions) times per session. We will provide a 20 second rest between trials, and a 10 minute break between the visual and tactile feedback exercises to decrease the effect of fatigue.
Biofeedback Intervention: Visual and Tactile Biofeedback
|
Control
n=19 Participants
The 6-week attention control group program will focus on providing educational information to the participants related to the clinical and sports expectations as they are released to return to sport. These participants will be asked to meet 6 times during the 6-week intervention time period. Three of these visits will be completed in person and three will be completed using an online educational module (6 sessions). The online sessions will be completed in week 1, week 3, and week 5 while the in person sessions will be completed during week 2, week 4, and week 6.
|
|---|---|---|
|
Change in Peak Vertical Ground Reaction Force Symmetry
Baseline
|
34.1 % Symmetry
Standard Deviation 23
|
28 % Symmetry
Standard Deviation 9.4
|
|
Change in Peak Vertical Ground Reaction Force Symmetry
Post-intervention
|
24.6 % Symmetry
Standard Deviation 14
|
25.7 % Symmetry
Standard Deviation 12.9
|
SECONDARY outcome
Timeframe: Post-intervention (week 6) and Retention (week 12)Population: Analysis completed with participants with \>80% adherence
The peak vertical ground reaction force symmetry will be assessed during the first landing of a stop-jump task
Outcome measures
| Measure |
Biofeedback Intervention
n=11 Participants
The 6-week biofeedback training program is focused on altering loading and movement asymmetry during biweekly sessions on non-consecutive days (12 sessions). The biofeedback training program will provide sensory (visual and tactile) feedback to the subject to heighten awareness of asymmetrical movement strategies (e.g. load shift, movement asymmetry) during a squat. The two exercises that will be completed during the biofeedback training program will be a visual feedback squat and a resisted squat (tactile feedback). Each of these tasks will be completed 30 (3 sets of 10 repetitions) times per session. We will provide a 20 second rest between trials, and a 10 minute break between the visual and tactile feedback exercises to decrease the effect of fatigue.
Biofeedback Intervention: Visual and Tactile Biofeedback
|
Control
n=19 Participants
The 6-week attention control group program will focus on providing educational information to the participants related to the clinical and sports expectations as they are released to return to sport. These participants will be asked to meet 6 times during the 6-week intervention time period. Three of these visits will be completed in person and three will be completed using an online educational module (6 sessions). The online sessions will be completed in week 1, week 3, and week 5 while the in person sessions will be completed during week 2, week 4, and week 6.
|
|---|---|---|
|
Change in Peak Vertical Ground Reaction Force Symmetry
Post-intervention
|
24.6 % Symmetry
Standard Deviation 14
|
25.7 % Symmetry
Standard Deviation 12.9
|
|
Change in Peak Vertical Ground Reaction Force Symmetry
Retention
|
32.5 % Symmetry
Standard Deviation 14.5
|
22.7 % Symmetry
Standard Deviation 9.2
|
Adverse Events
Biofeedback Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
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