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| ID | Type | Description | Link |
|---|---|---|---|
| R21AR069865-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biofeedback Intervention | Experimental | 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. |
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| Control | No 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biofeedback Intervention | Other | Visual and Tactile Biofeedback |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | Post-intervention (week 6) and Retention (week 12) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline (week 0) and Post-intervention (week 6) |
| Change in Frontal Plane Knee Range of Motion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robin M Queen, PhD | Virginia Polytechnic Institute and State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Tech - Kevin P. Granata Biomechanics Lab | Blacksburg | Virginia | 24060 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35940085 | Derived | Peebles AT, Miller TK, Savla J, Ollendick T, Messier SP, Queen RM. Reduction of risk factors for ACL Re-injuries using an innovative biofeedback approach: A phase I randomized clinical trial. Phys Ther Sport. 2022 Sep;57:78-88. doi: 10.1016/j.ptsp.2022.07.007. Epub 2022 Jul 16. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Analysis completed with participants with >80% adherence | Posted | Mean | Standard Deviation | % Symmetry | Baseline (week 0) and Post-intervention (week 6) |
|
Data was collected over the 12 weeks during which the participants were active on the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Robin Queen | Virginia Tech | (540) 231-3134 | rmqueen@vt.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 27, 2020 | Oct 27, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000070598 | Anterior Cruciate Ligament Injuries |
| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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This study involves one active intervention group and an attention control group
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To reduce the possibility of bias, the biofeedback intervention will be completed by a single individual (clinician - Athletic trainer) and the biomechanical assessments will be completed by a second individual who will be blinded to the subject's group assignment (research technician).
The frontal plane knee range of motion will be assessed during the first landing of a stop-jump task
| 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 | 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 | Post-intervention (week 6) and Retention (week 12) |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Peak Knee Extension Moment Symmetry | Mean | Standard Deviation | % Symmetry |
|
| OG001 | 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. |
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| Primary | 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 | Analysis completed with participants with >80% adherence | Posted | Mean | Standard Deviation | % Symmetry | Post-intervention (week 6) and Retention (week 12) |
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| Secondary | 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 | Analysis completed with participants with >80% adherence | Posted | Mean | Standard Deviation | Degree | Baseline (week 0) and Post-intervention (week 6) |
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| Secondary | 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 | Analysis completed with participants with >80% adherence | Posted | Mean | Standard Deviation | Degree | Post-intervention (week 6) and Retention (week 12) |
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| Secondary | 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 | Analysis completed with participants with >80% adherence | Posted | Mean | Standard Deviation | % Symmetry | Baseline (week 0) and Post-intervention (week 6) |
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| Secondary | 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 | Analysis completed with participants with >80% adherence | Posted | Mean | Standard Deviation | % Symmetry | Post-intervention (week 6) and Retention (week 12) |
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| 0 |
| 18 |
| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | 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. | 0 | 22 | 0 | 22 | 0 | 22 |
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