Trial Outcomes & Findings for Optimizing Movement After Anterior Cruciate Ligament Injury (NCT NCT05363683)

Last Updated: 2025-12-12

Results Overview

Participants completed 3 sets of 5 bilateral bodyweight squats with arms crossed at the chest, with the middle 3 of each set (9 total) averaged and reported. The external knee flexion moment was calculated using an inverse dynamics approach. The interlimb ratio (injured limb / uninjured limb) of the knee flexion moment impulse during descent and ascent of bilateral squatting was analyzed at post-intervention. A value of 1 represents symmetric knee flexion moment impulse; a value less than 1 represents a smaller knee flexion moment impulse in the injured compared to uninjured limb.

Recruitment status

COMPLETED

Study phase

Target enrollment

34 participants

Primary outcome timeframe

Immediately post-intervention (within approximately 1 week after completing intervention)

Results posted on

2025-12-12

Participant Flow

Participant milestones

Participant milestones
Measure	Biofeedback Group Provided real-time visual feedback on a screen during bilateral squat intervention.	Control Group Provided standard verbal instructions during bilateral squat intervention.
Overall Study STARTED	16	18
Overall Study COMPLETED	15	17
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

1 participant from the control group dropped from the study and did not complete any baseline test; 1 participant from the squat biofeedback group did not complete the demographics survey during baseline testing.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Immediately post-intervention (within approximately 1 week after completing intervention)

Outcome measures

Outcome measures
Measure	Biofeedback Group n=15 Participants Provided real-time visual feedback on a screen during bilateral squat intervention.	Control Group n=17 Participants Provided standard verbal instructions during bilateral squat intervention.
Knee Flexion Moment Impulse	0.54 Ratio Standard Deviation 0.28	0.50 Ratio Standard Deviation 0.21

PRIMARY outcome

Timeframe: Baseline (immediately before intervention, 2-6 weeks after anterior cruciate ligament reconstruction) and 6 months after anterior cruciate ligament reconstruction.

Percent change in cartilage T2 relaxation time will be measured by a magnetic resonance imaging (MRI) scan. A positive percent change represents longer (worse) T2 relaxation times at 6 months compared to baseline testing.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months after anterior cruciate ligament reconstruction.

Participants completed 3 sets of 5 bilateral bodyweight squats with arms crossed at the chest, with the middle 3 of each set (9 total) averaged and reported. The external knee flexion moment was calculated using an inverse dynamics approach. The interlimb ratio (injured limb / uninjured limb) of the knee flexion moment impulse during descent and ascent of bilateral squatting was analyzed at 6 months. A value of 1 represents symmetric knee flexion moment impulse; a value less than 1 represents a smaller knee flexion moment impulse in the injured compared to uninjured limb.

Outcome measures

Outcome measures
Measure	Biofeedback Group n=15 Participants Provided real-time visual feedback on a screen during bilateral squat intervention.	Control Group n=17 Participants Provided standard verbal instructions during bilateral squat intervention.
Knee Flexion Moment Impulse	0.66 Ratio Standard Deviation 0.24	0.54 Ratio Standard Deviation 0.21

SECONDARY outcome

Timeframe: Immediately post-intervention (approximately 1 week after intervention)

Participants completed 3 sets of 5 bilateral bodyweight squats with arms crossed at the chest, with the middle 3 of each set (9 total) averaged and reported. The vertical ground reaction force impulse was calculated. The interlimb ratio (injured limb / uninjured limb) of the vertical ground reaction force impulse during descent and ascent of bilateral squatting was analyzed at post-intervention. A value of 1 represents symmetric vertical ground reaction force impulse; a value less than 1 represents a smaller vertical ground reaction force impulse in the injured compared to uninjured limb.

Outcome measures

Outcome measures
Measure	Biofeedback Group n=15 Participants Provided real-time visual feedback on a screen during bilateral squat intervention.	Control Group n=17 Participants Provided standard verbal instructions during bilateral squat intervention.
Vertical Ground Reaction Force Impulse	0.91 Ratio Standard Deviation 0.08	0.84 Ratio Standard Deviation 0.11

SECONDARY outcome

Timeframe: 6 months after anterior cruciate ligament reconstruction.

Participants completed 3 sets of 5 bilateral bodyweight squats with arms crossed at the chest, with the middle 3 of each set (9 total) averaged and reported. The vertical ground reaction force impulse was calculated. The interlimb ratio (injured limb / uninjured limb) of the vertical ground reaction force impulse during descent and ascent of bilateral squatting was analyzed at 6 months. A value of 1 represents symmetric vertical ground reaction force impulse; a value less than 1 represents a smaller vertical ground reaction force impulse in the injured compared to uninjured limb.

Outcome measures

Outcome measures
Measure	Biofeedback Group n=15 Participants Provided real-time visual feedback on a screen during bilateral squat intervention.	Control Group n=17 Participants Provided standard verbal instructions during bilateral squat intervention.
Vertical Ground Reaction Force Impulse	0.95 N/A (Ratio) Standard Deviation 0.08	0.86 N/A (Ratio) Standard Deviation 0.10

SECONDARY outcome

Timeframe: Immediately post-intervention (within approximately 1 week after completing intervention)

Participants completed 5 valid trials of walking in each limb. The external knee flexion moment was calculated using an inverse dynamics approach. The interlimb ratio (injured limb / uninjured limb) of the peak knee flexion moment during walking was analyzed at post-intervention. A value of 1 represents symmetric peak knee flexion moment; a value less than 1 represents a smaller peak knee flexion moment in the injured compared to uninjured limb.

Outcome measures

Outcome measures
Measure	Biofeedback Group n=15 Participants Provided real-time visual feedback on a screen during bilateral squat intervention.	Control Group n=17 Participants Provided standard verbal instructions during bilateral squat intervention.
Peak Knee Flexion Moment	0.6 Ratio Interval 0.2 to 0.8	0.7 Ratio Interval 0.4 to 0.8

SECONDARY outcome

Timeframe: 6 months after anterior cruciate ligament reconstruction.

Participants completed 5 valid trials of walking in each limb. The external knee flexion moment was calculated using an inverse dynamics approach. The interlimb ratio (injured limb / uninjured limb) of the peak knee flexion moment during walking was analyzed at 6 months. A value of 1 represents symmetric peak knee flexion moment; a value less than 1 represents a smaller peak knee flexion moment in the injured compared to uninjured limb.

Outcome measures

Outcome measures
Measure	Biofeedback Group n=15 Participants Provided real-time visual feedback on a screen during bilateral squat intervention.	Control Group n=17 Participants Provided standard verbal instructions during bilateral squat intervention.
Peak Knee Flexion Moment	0.7 Ratio Interval 0.6 to 0.9	0.7 Ratio Interval 0.6 to 0.9

SECONDARY outcome

Timeframe: Immediately post-intervention (within approximately 1 week after completing intervention)

Participants completed 3 trials of maximal isometric quadriceps strength testing using an isokinetic dynamometer at each limb, with the best trial in each limb used for analysis. The interlimb ratio (injured limb / uninjured limb) of maximum quadriceps strength was analyzed at post-intervention. A value of 1 represents symmetric quadriceps strength; a value less than 1 represents less quadriceps strength in the injured compared to uninjured limb.

Outcome measures

Outcome measures
Measure	Biofeedback Group n=15 Participants Provided real-time visual feedback on a screen during bilateral squat intervention.	Control Group n=17 Participants Provided standard verbal instructions during bilateral squat intervention.
Quadriceps Strength	0.5 Ratio Interval 0.4 to 0.6	0.5 Ratio Interval 0.5 to 0.6

SECONDARY outcome

Timeframe: 6 months after anterior cruciate ligament reconstruction.

Participants completed 3 trials of maximal isometric quadriceps strength testing using an isokinetic dynamometer at each limb, with the best trial in each limb used for analysis. The interlimb ratio (injured limb / uninjured limb) of maximum quadriceps strength was analyzed at 6 months. A value of 1 represents symmetric quadriceps strength; a value less than 1 represents less quadriceps strength in the injured compared to uninjured limb.

Outcome measures

Outcome measures
Measure	Biofeedback Group n=15 Participants Provided real-time visual feedback on a screen during bilateral squat intervention.	Control Group n=17 Participants Provided standard verbal instructions during bilateral squat intervention.
Quadriceps Strength	0.8 Ratio Interval 0.5 to 0.8	0.6 Ratio Interval 0.6 to 0.7

Adverse Events

Biofeedback Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

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

Elizabeth Wellsandt

University of Nebraska Medical Center

Phone: 402-559-4309

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Biofeedback Group n=16 Participants Provided real-time visual feedback on a screen during bilateral squat intervention.	Control Group n=17 Participants Provided standard verbal instructions during bilateral squat intervention.	Total n=33 Participants Total of all reporting groups
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=15 Participants • 1 participant from the control group dropped from the study and did not complete any baseline test; 1 participant from the squat biofeedback group did not complete the demographics survey during baseline testing.	0 Participants n=17 Participants • 1 participant from the control group dropped from the study and did not complete any baseline test; 1 participant from the squat biofeedback group did not complete the demographics survey during baseline testing.	0 Participants n=32 Participants • 1 participant from the control group dropped from the study and did not complete any baseline test; 1 participant from the squat biofeedback group did not complete the demographics survey during baseline testing.
Age, Continuous	20.9 Years STANDARD_DEVIATION 6.6 • n=15 Participants • 1 participant from the control group dropped from the study and did not complete any baseline test; 1 participant from the squat biofeedback group did not complete the demographics survey during baseline testing.	19.3 Years STANDARD_DEVIATION 4.6 • n=17 Participants • 1 participant from the control group dropped from the study and did not complete any baseline test; 1 participant from the squat biofeedback group did not complete the demographics survey during baseline testing.	20.1 Years STANDARD_DEVIATION 5.6 • n=32 Participants • 1 participant from the control group dropped from the study and did not complete any baseline test; 1 participant from the squat biofeedback group did not complete the demographics survey during baseline testing.
Sex: Female, Male Female	10 Participants n=15 Participants • 1 participant from the control group dropped from the study and did not complete any baseline test; 1 participant from the squat biofeedback group did not complete the demographics survey during baseline testing.	5 Participants n=17 Participants • 1 participant from the control group dropped from the study and did not complete any baseline test; 1 participant from the squat biofeedback group did not complete the demographics survey during baseline testing.	15 Participants n=32 Participants • 1 participant from the control group dropped from the study and did not complete any baseline test; 1 participant from the squat biofeedback group did not complete the demographics survey during baseline testing.
Sex: Female, Male Male	5 Participants n=15 Participants • 1 participant from the control group dropped from the study and did not complete any baseline test; 1 participant from the squat biofeedback group did not complete the demographics survey during baseline testing.	12 Participants n=17 Participants • 1 participant from the control group dropped from the study and did not complete any baseline test; 1 participant from the squat biofeedback group did not complete the demographics survey during baseline testing.	17 Participants n=32 Participants • 1 participant from the control group dropped from the study and did not complete any baseline test; 1 participant from the squat biofeedback group did not complete the demographics survey during baseline testing.
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=15 Participants • 1 participant from the control group dropped from the study and did not complete any baseline test; 1 participant from the squat biofeedback group did not complete the demographics survey during baseline testing.	1 Participants n=17 Participants • 1 participant from the control group dropped from the study and did not complete any baseline test; 1 participant from the squat biofeedback group did not complete the demographics survey during baseline testing.	1 Participants n=32 Participants • 1 participant from the control group dropped from the study and did not complete any baseline test; 1 participant from the squat biofeedback group did not complete the demographics survey during baseline testing.
Race (NIH/OMB) Asian	1 Participants n=15 Participants • 1 participant from the control group dropped from the study and did not complete any baseline test; 1 participant from the squat biofeedback group did not complete the demographics survey during baseline testing.	1 Participants n=17 Participants • 1 participant from the control group dropped from the study and did not complete any baseline test; 1 participant from the squat biofeedback group did not complete the demographics survey during baseline testing.	2 Participants n=32 Participants • 1 participant from the control group dropped from the study and did not complete any baseline test; 1 participant from the squat biofeedback group did not complete the demographics survey during baseline testing.
Race (NIH/OMB) Black or African American	1 Participants n=15 Participants • 1 participant from the control group dropped from the study and did not complete any baseline test; 1 participant from the squat biofeedback group did not complete the demographics survey during baseline testing.	2 Participants n=17 Participants • 1 participant from the control group dropped from the study and did not complete any baseline test; 1 participant from the squat biofeedback group did not complete the demographics survey during baseline testing.	3 Participants n=32 Participants • 1 participant from the control group dropped from the study and did not complete any baseline test; 1 participant from the squat biofeedback group did not complete the demographics survey during baseline testing.
Race (NIH/OMB) White	10 Participants n=15 Participants • 1 participant from the control group dropped from the study and did not complete any baseline test; 1 participant from the squat biofeedback group did not complete the demographics survey during baseline testing.	8 Participants n=17 Participants • 1 participant from the control group dropped from the study and did not complete any baseline test; 1 participant from the squat biofeedback group did not complete the demographics survey during baseline testing.	18 Participants n=32 Participants • 1 participant from the control group dropped from the study and did not complete any baseline test; 1 participant from the squat biofeedback group did not complete the demographics survey during baseline testing.
Race (NIH/OMB) More than one race	1 Participants n=15 Participants • 1 participant from the control group dropped from the study and did not complete any baseline test; 1 participant from the squat biofeedback group did not complete the demographics survey during baseline testing.	1 Participants n=17 Participants • 1 participant from the control group dropped from the study and did not complete any baseline test; 1 participant from the squat biofeedback group did not complete the demographics survey during baseline testing.	2 Participants n=32 Participants • 1 participant from the control group dropped from the study and did not complete any baseline test; 1 participant from the squat biofeedback group did not complete the demographics survey during baseline testing.
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=15 Participants • 1 participant from the control group dropped from the study and did not complete any baseline test; 1 participant from the squat biofeedback group did not complete the demographics survey during baseline testing.	4 Participants n=17 Participants • 1 participant from the control group dropped from the study and did not complete any baseline test; 1 participant from the squat biofeedback group did not complete the demographics survey during baseline testing.	6 Participants n=32 Participants • 1 participant from the control group dropped from the study and did not complete any baseline test; 1 participant from the squat biofeedback group did not complete the demographics survey during baseline testing.
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=15 Participants • 1 participant from the control group dropped from the study and did not complete any baseline test; 1 participant from the squat biofeedback group did not complete the demographics survey during baseline testing.	5 Participants n=17 Participants • 1 participant from the control group dropped from the study and did not complete any baseline test; 1 participant from the squat biofeedback group did not complete the demographics survey during baseline testing.	8 Participants n=32 Participants • 1 participant from the control group dropped from the study and did not complete any baseline test; 1 participant from the squat biofeedback group did not complete the demographics survey during baseline testing.
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=15 Participants • 1 participant from the control group dropped from the study and did not complete any baseline test; 1 participant from the squat biofeedback group did not complete the demographics survey during baseline testing.	12 Participants n=17 Participants • 1 participant from the control group dropped from the study and did not complete any baseline test; 1 participant from the squat biofeedback group did not complete the demographics survey during baseline testing.	24 Participants n=32 Participants • 1 participant from the control group dropped from the study and did not complete any baseline test; 1 participant from the squat biofeedback group did not complete the demographics survey during baseline testing.
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=15 Participants • 1 participant from the control group dropped from the study and did not complete any baseline test; 1 participant from the squat biofeedback group did not complete the demographics survey during baseline testing.	0 Participants n=17 Participants • 1 participant from the control group dropped from the study and did not complete any baseline test; 1 participant from the squat biofeedback group did not complete the demographics survey during baseline testing.	0 Participants n=32 Participants • 1 participant from the control group dropped from the study and did not complete any baseline test; 1 participant from the squat biofeedback group did not complete the demographics survey during baseline testing.
Knee Flexion Moment Impulse at Baseline	0.23 Ratio STANDARD_DEVIATION 0.19 • n=16 Participants • 1 participant from the control group dropped from the study and did not complete any baseline testing.	0.26 Ratio STANDARD_DEVIATION 0.16 • n=17 Participants • 1 participant from the control group dropped from the study and did not complete any baseline testing.	0.25 Ratio STANDARD_DEVIATION 0.18 • n=33 Participants • 1 participant from the control group dropped from the study and did not complete any baseline testing.
Vertical Ground Reaction Force Impulse at Baseline	0.72 Ratio STANDARD_DEVIATION 0.11 • n=16 Participants • 1 participant from the control group dropped from the study and did not complete any baseline testing. 1 participant from the squat biofeedback group dropped after part of baseline testing was completed with no follow-up testing completed; therefore, their data was not used as a covariate in ANCOVA analyses.	0.72 Ratio STANDARD_DEVIATION 0.12 • n=17 Participants • 1 participant from the control group dropped from the study and did not complete any baseline testing. 1 participant from the squat biofeedback group dropped after part of baseline testing was completed with no follow-up testing completed; therefore, their data was not used as a covariate in ANCOVA analyses.	0.72 Ratio STANDARD_DEVIATION 0.11 • n=33 Participants • 1 participant from the control group dropped from the study and did not complete any baseline testing. 1 participant from the squat biofeedback group dropped after part of baseline testing was completed with no follow-up testing completed; therefore, their data was not used as a covariate in ANCOVA analyses.