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

NCT03273673 | Completed Results DMC

• 2 other identifiers: 17-007R21AR069865-01A1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Anterior Cruciate Ligament Injury

Keywords

Secondary ACL Injury Prevention; Visual Biofeedback; Tactile Biofeedback

Outcome Measures

Primary Outcomes (2)

• 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)

Secondary Outcomes (4)

• Change in Frontal Plane Knee Range of Motion

  Baseline (week 0) and Post-intervention (week 6)

• Change in Frontal Plane Knee Range of Motion

  Post-intervention (week 6) and Retention (week 12)

• Change in Peak Vertical Ground Reaction Force Symmetry

  Baseline (week 0) and Post-intervention (week 6)

• Change in Peak Vertical Ground Reaction Force Symmetry

  Post-intervention (week 6) and Retention (week 12)

Study Arms (2)

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.

Other: Biofeedback Intervention

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.

Interventions

Biofeedback Intervention OTHER

Visual and Tactile Biofeedback

Biofeedback Intervention

Eligibility Criteria

• Age: 14 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Polytechnic Institute and State University: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

Virginia Tech - Kevin P. Granata Biomechanics Lab

Blacksburg, Virginia, 24060, United States

Location

Related Publications (1)

• 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.

  PMID: 35940085 DERIVED

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Results Point of Contact

• Title: Dr. Robin Queen
• Organization: Virginia Tech

rmqueen@vt.edu

(540) 231-3134

Study Officials

• Robin M Queen, PhD

  Virginia Polytechnic Institute and State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This study involves one active intervention group and an attention control group

Study Record Dates

• First Submitted: September 1, 2017
• First Posted: September 6, 2017
• Study Start: March 20, 2018
• Primary Completion: May 5, 2020
• Study Completion: May 5, 2020
• Last Updated: December 4, 2020
• Results First Posted: December 4, 2020

Record last verified: 2020-12

Locations

US (1)