Status:
COMPLETED
Reduction of Risk Factors for ACL Re-injuries Using a Novel Biofeedback Approach
Lead Sponsor:
Virginia Polytechnic Institute and State University
Collaborating Sponsors:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Conditions:
Anterior Cruciate Ligament Injury
Eligibility:
All Genders
14-21 years
Phase:
NA
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 injur...
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 reconstruct...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 20 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 5 2020
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03273673
Start Date
March 20 2018
End Date
May 5 2020
Last Update
December 4 2020
Active Locations (1)
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1
Virginia Tech - Kevin P. Granata Biomechanics Lab
Blacksburg, Virginia, United States, 24060