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Trial record 1 of 1 for:    NCT03273673
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Reduction of Risk Factors for ACL Re-injuries Using a Novel Biofeedback Approach

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ClinicalTrials.gov Identifier: NCT03273673
Recruitment Status : Completed
First Posted : September 6, 2017
Results First Posted : December 4, 2020
Last Update Posted : December 4, 2020
Sponsor:
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Robin Queen, Virginia Polytechnic Institute and State University

Tracking Information
First Submitted Date  ICMJE September 1, 2017
First Posted Date  ICMJE September 6, 2017
Results First Submitted Date  ICMJE October 28, 2020
Results First Posted Date  ICMJE December 4, 2020
Last Update Posted Date December 4, 2020
Actual Study Start Date  ICMJE March 20, 2018
Actual Primary Completion Date May 5, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 4, 2017)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 4, 2017)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Reduction of Risk Factors for ACL Re-injuries Using a Novel Biofeedback Approach
Official Title  ICMJE Reduction of Risk Factors for ACL Re-injuries Using an Innovative Biofeedback Approach
Brief 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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
This study involves one active intervention group and an attention control group
Masking: Double (Care Provider, Outcomes Assessor)
Masking Description:
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).
Primary Purpose: Treatment
Condition  ICMJE Anterior Cruciate Ligament Injury
Intervention  ICMJE Other: Biofeedback Intervention
Visual and Tactile Biofeedback
Study Arms  ICMJE
  • 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.
    Intervention: Other: Biofeedback Intervention
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 4, 2017)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 5, 2020
Actual Primary Completion Date May 5, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 14 Years to 21 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03273673
Other Study ID Numbers  ICMJE 17-007
R21AR069865-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Robin Queen, Virginia Polytechnic Institute and State University
Study Sponsor  ICMJE Virginia Polytechnic Institute and State University
Collaborators  ICMJE National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators  ICMJE
Principal Investigator: Robin M Queen, PhD Virginia Polytechnic Institute and State University
PRS Account Virginia Polytechnic Institute and State University
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP