Reduction of Risk Factors for ACL Re-injuries Using a Novel Biofeedback Approach

Overview

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.

Full Title of Study: “Reduction of Risk Factors for ACL Re-injuries Using an Innovative Biofeedback Approach”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Care Provider, Outcomes Assessor)
  • Study Primary Completion Date: October 1, 2019

Interventions

  • Other: Biofeedback Intervention
    • Visual and Tactile Biofeedback

Arms, Groups and Cohorts

  • Experimental: 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.
  • No Intervention: 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.

Clinical Trial Outcome Measures

Primary Measures

  • Change in Peak Knee Extension Moment Symmetry
    • Time Frame: Baseline (week 0) and Post-intervention (week 6)
    • The peak knee extension moment asymmetry will be assessed during the first landing of a stop-jump task
  • Change in Peak Knee Extension Moment Symmetry
    • Time Frame: Post-intervention (week 6) and Retention (week 12)
    • The peak knee extension moment asymmetry will be assessed during the first landing of a stop-jump task

Secondary Measures

  • Change in Frontal Plane Knee Range of Motion
    • Time Frame: Baseline (week 0) and Post-intervention (week 6)
    • The frontal plane knee range of motion will be assessed during the first landing of a stop-jump task
  • Change in Frontal Plane Knee Range of Motion
    • Time Frame: Post-intervention (week 6) and Retention (week 12)
    • The frontal plane knee range of motion will be assessed during the first landing of a stop-jump task
  • Change in Peak Vertical Ground Reaction Force Symmetry
    • Time Frame: Baseline (week 0) and Post-intervention (week 6)
    • The peak vertical ground reaction force symmetry will be assessed during the first landing of a stop-jump task
  • Change in Peak Vertical Ground Reaction Force Symmetry
    • Time Frame: Post-intervention (week 6) and Retention (week 12)
    • The peak vertical ground reaction force symmetry will be assessed during the first landing of a stop-jump task

Participating in This Clinical Trial

Inclusion Criteria

1. Provision of signed and dated informed consent form

2. ACL Reconstruction: primary, unilateral ACL reconstruction with no pain in the contralateral leg

3. 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

4. Stated willingness to comply with all study procedures and availability for the duration of the study

5. Male or female, aged 14-21

6. Willing to adhere to the ACL Biofeedback intervention regimen

Exclusion Criteria

1. For females: currently pregnant or planning to become pregnant

2. History of more than one ACL reconstruction

3. Post-operative complications that required additional surgical intervention

4. Hospitalization for any reason other than the ACL reconstruction in the last 3 months

5. Plans for additional surgical procedures in the next 12 months

6. Live greater than 60 miles from the research lab

7. Have limitations that would prevent them from attending the biofeedback training sessions

8. Motor neuron diseases, Parkinson's disease, multiple sclerosis

9. Severely impaired hearing or speech (patients must be able to respond to phone calls)

10. No access to a telephone

11. Participating in another ACL intervention

12. Inability to understand or speak English (since this will be required for the patient-based intervention)

13. Other self-reported medical problem that would prohibit participation in the study

14. Other health condition or personal issue judged by a study team member or primary care physician to make the patient inappropriate for study participation

15. Knee extension moment limb symmetry index (LSI) greater than or equal to 90% at the time of the initial study assessment

Gender Eligibility: All

Minimum Age: 14 Years

Maximum Age: 21 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Virginia Polytechnic Institute and State University
  • Collaborator
    • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
  • Provider of Information About this Clinical Study
    • Principal Investigator: Robin Queen, Associate Professor – Virginia Polytechnic Institute and State University

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