N/A
N=40
Reduction of Risk Factors for ACL Re-injuries Using a Novel Biofeedback Approach
Anterior Cruciate Ligament Injury
Bottom Line
View on ClinicalTrials.gov: NCT03273673 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcome: Primary: Change in Peak Knee Extension Moment Symmetry — 50.1; 44.2; 44.6; 40.6 % Symmetry
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Biofeedback Intervention (Other)
- Age
- Pediatric, Adult · 14+ yrs
- Sex
- All
- Sponsor
- Virginia Polytechnic Institute and State University
- Primary completion
- May 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Peak Knee Extension Moment Symmetry |
44.6; 40.6; 38.7; 33.3 | — |
| PRIMARY Change in Peak Knee Extension Moment Symmetry |
44.6; 40.6; 38.7; 33.3 | — |
| SECONDARY Change in Frontal Plane Knee Range of Motion |
7.5; 9.1; 7.9; 10.1 | — |
| SECONDARY Change in Frontal Plane Knee Range of Motion |
7.5; 9.1; 7.9; 10.1 | — |
| SECONDARY Change in Peak Vertical Ground Reaction Force Symmetry |
24.6; 25.7; 32.5; 22.7 | — |
| SECONDARY Change in Peak Vertical Ground Reaction Force Symmetry |
24.6; 25.7; 32.5; 22.7 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Provision of signed and dated informed consent form
- ACL Reconstruction: primary, unilateral ACL reconstruction with no pain in the contralateral leg
- Rehabilitation: need to have completed at least 4.5 months of post-operative physical therapy and be within approximately 6 weeks of being ready to be released by his/her treating orthopaedic surgeon to return to full sport participation
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 14-21
- Willing to adhere to the ACL Biofeedback intervention regimen
Exclusion Criteria
- For females: currently pregnant or planning to become pregnant
- History of more than one ACL reconstruction
- Post-operative complications that required additional surgical intervention
- Hospitalization for any reason other than the ACL reconstruction in the last 3 months
- Plans for additional surgical procedures in the next 12 months
- Live greater than 60 miles from the research lab
- Have limitations that would prevent them from attending the biofeedback training sessions
- Motor neuron diseases, Parkinson's disease, multiple sclerosis
- Severely impaired hearing or speech (patients must be able to respond to phone calls)
- No access to a telephone
- Participating in another ACL intervention
- Inability to understand or speak English (since this will be required for the patient-based intervention)
- Other self-reported medical problem that would prohibit participation in the study
- Other health condition or personal issue judged by a study team member or primary care physician to make the patient inappropriate for study participation
- Knee extension moment limb symmetry index (LSI) greater than or equal to 90% at the time of the initial study assessment
Data sourced from ClinicalTrials.gov (NCT03273673). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.