An interventional study of Biofeedback Intervention in Anterior Cruciate Ligament Injury, sponsored by Virginia Polytechnic Institute and State University. Completed at 1 site in United States. Open to participants aged 14 Years to 21 Years. Per ClinicalTrials.gov, last updated 2020-12-04.
Sponsored by Virginia Polytechnic Institute and State University · Not applicable, Interventional, and Treatment
ACL injuries are common among athletes and due to residual muscle weakness, limited knee motion and asymmetrical movement patterns after surgery many of these athletes will sustain secondary ACL injuries following return to sports. This project seeks to determine if a novel biofeedback-based rehabilitation approach can decrease a known risk factor for secondary injuries to the ACL. The project specifically focuses on correcting asymmetric movement patterns, a known risk factor for secondary injury that is not directly addressed by existing interventions through a 6 week therapy based biofeedback intervention.
Nearly 1 in 60 adolescent athletes will suffer ACL injuries. Approximately 90% of these injured athletes will undergo an ACL reconstruction at an estimated annual cost of $3 billion. While reconstruction and subsequent rehabilitation allow these athletes to return to sports, they have a 15 fold increased risk of secondary ACL injuries, a tear of the ACL graft or the contralateral ACL. As a result, development of an intervention to reduce the incidence of secondary ACL tears would meet a critical need. One area in which existing interventions might be improved is through an increased emphasis on correcting asymmetric movement patterns-a known risk factor for secondary injury. Thus, our long-term objective is to decrease the number of secondary ACL tears by decreasing side-to-side movement and loading asymmetry. The modification of post-operative rehabilitation to focus on movement and loading symmetry with shift the rehabilitation paradigm. Specifically, we propose to evaluate a novel biofeedback training program that focuses on altering loading and movement patterns to improve symmetry and overall lower extremity mechanics in a group of 40 (20 control, 20 intervention) adolescent ACL reconstructed patients. There are two core hypotheses of this study: 1) biofeedback training will decrease known risk factors for secondary ACL injuries immediately following the biofeedback program and these changes will be retained 6 week after the completion of the biofeedback program; and 2) we will be able to recruit and enroll 40 patients and retain 80% of the patients through the end of the follow-up assessment demonstrating the feasibility of the biofeedback intervention. Implementation of a biofeedback program prior to returning to dynamic athletic activities could improve physical performance outcomes, decrease secondary injury risk factors and ultimately decrease the long-term joint degeneration and development of osteoarthritis that has been associated with ACL reconstruction. Ultimately this work will lead to additional investigations to definitively determine the impact of this novel biofeedback program, which could shift the post-operative rehabilitation paradigm following ACL reconstruction to improve long-term joint health in these adolescent patients.
Exclusion Criteria:
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.
Other: Biofeedback Intervention
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.
Visual and Tactile Biofeedback
Change in Peak Knee Extension Moment Symmetry
The peak knee extension moment asymmetry will be assessed during the first landing of a stop-jump task
Time frame: Baseline (week 0) and Post-intervention (week 6)
Change in Peak Knee Extension Moment Symmetry
The peak knee extension moment asymmetry will be assessed during the first landing of a stop-jump task
Time frame: Post-intervention (week 6) and Retention (week 12)
Change in Frontal Plane Knee Range of Motion
The frontal plane knee range of motion will be assessed during the first landing of a stop-jump task
Time frame: Baseline (week 0) and Post-intervention (week 6)
Change in Frontal Plane Knee Range of Motion
The frontal plane knee range of motion will be assessed during the first landing of a stop-jump task
Time frame: Post-intervention (week 6) and Retention (week 12)
Change in Peak Vertical Ground Reaction Force Symmetry
The peak vertical ground reaction force symmetry will be assessed during the first landing of a stop-jump task
Time frame: Baseline (week 0) and Post-intervention (week 6)
Change in Peak Vertical Ground Reaction Force Symmetry
The peak vertical ground reaction force symmetry will be assessed during the first landing of a stop-jump task
Time frame: Post-intervention (week 6) and Retention (week 12)
| Milestone | Biofeedback Intervention | Control |
|---|---|---|
| Started | 18 | 22 |
| Completed | 14 | 22 |
| Not completed | 4 | 0 |
The peak knee extension moment asymmetry will be assessed during the first landing of a stop-jump task
| % Symmetry | Biofeedback Intervention | Control |
|---|---|---|
| Baseline | 50.1 ± 33.8 | 44.2 ± 26 |
| Post-intervention | 44.6 ± 24.2 | 40.6 ± 16.7 |
The peak knee extension moment asymmetry will be assessed during the first landing of a stop-jump task
| % Symmetry | Biofeedback Intervention | Control |
|---|---|---|
| Post-intervention | 44.6 ± 24.2 | 40.6 ± 16.7 |
| Retention | 38.7 ± 22.5 | 33.3 ± 13.5 |
The frontal plane knee range of motion will be assessed during the first landing of a stop-jump task
| Degree | Biofeedback Intervention | Control |
|---|---|---|
| Baseline | 6.4 ± 2.7 | 10.1 ± 4.4 |
| Post-Intervention | 7.5 ± 4.5 | 9.1 ± 4.3 |
The frontal plane knee range of motion will be assessed during the first landing of a stop-jump task
| Degree | Biofeedback Intervention | Control |
|---|---|---|
| Post-intervention | 7.5 ± 4.5 | 9.1 ± 4.3 |
| Retention | 7.9 ± 4.2 | 10.1 ± 4.6 |
The peak vertical ground reaction force symmetry will be assessed during the first landing of a stop-jump task
| % Symmetry | Biofeedback Intervention | Control |
|---|---|---|
| Baseline | 34.1 ± 23 | 28 ± 9.4 |
| Post-intervention | 24.6 ± 14 | 25.7 ± 12.9 |
The peak vertical ground reaction force symmetry will be assessed during the first landing of a stop-jump task
| % Symmetry | Biofeedback Intervention | Control |
|---|---|---|
| Post-intervention | 24.6 ± 14 | 25.7 ± 12.9 |
| Retention | 32.5 ± 14.5 | 22.7 ± 9.2 |
Collected over Data was collected over the 12 weeks during which the participants were active on the study.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Biofeedback Intervention | 0/18 (0%) | 0/18 (0%) | 0/18 (0%) |
| Control | 0/22 (0%) | 0/22 (0%) | 0/22 (0%) |
| Age, Continuous(years) | Biofeedback Intervention | Control | Total |
|---|---|---|---|
| Mean | 16.2 ± 1.6 | 16.4 ± 2.2 | 16.3 ± 1.9 |
| Sex: Female, Male(Participants) | Biofeedback Intervention | Control | Total |
|---|---|---|---|
| Female | 6 | 10 | 16 |
| Male | 12 | 12 | 24 |
| Ethnicity (NIH/OMB)(Participants) | Biofeedback Intervention | Control | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 1 | 2 |
| Not Hispanic or Latino | 17 | 19 | 36 |
| Unknown or Not Reported | 0 | 2 | 2 |
| Race (NIH/OMB)(Participants) | Biofeedback Intervention | Control | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 1 |
| White | 14 | 21 | 35 |
| More than one race | 3 | 0 | 3 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Region of Enrollment(participants) | Biofeedback Intervention | Control | Total |
|---|---|---|---|
| United States | 18 | 22 | 40 |
| Peak Knee Extension Moment Symmetry(% Symmetry) | Biofeedback Intervention | Control | Total |
|---|---|---|---|
| Mean | 47.9 ± 28.4 | 41.4 ± 16.3 | 44.3 ± 22.5 |
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Virginia Polytechnic Institute and State University