Effect of Altered Mechanical Loading in ACLR

NCT03035994 | Completed

• 1 other identifier: 16-0409
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

Altered loading is a causative factor for the development of knee osteoarthritis following anterior cruciate ligament reconstruction (ACLR), and real-time biofeedback may be an effective intervention to manipulate altered mechanical loading about the knee. The purpose of this study is to 1) determine if ACLR participants are able to acquire and retain various loading patterns using real-time biofeedback, 2) determine the effect of altered loading on lower extremity biomechanics during walking gait, and 3) determine the effect of altered loading on biochemical markers of collagen turnover and inflammation during walking gait.

Conditions

Anterior Cruciate Ligament Reconstruction

Outcome Measures

Primary Outcomes (3)

• Difference in acquisition as measured in root mean square error (RMSE) between loading conditions

  Change in acquisition over 20 minute intervention

• Difference in joint loading as measured in peak vertical ground reaction force normalized to body weight (xBW) between loading conditions

  Change in joint loading over 20 minute intervention

• Difference in cartilage turnover as measured in serum concentration of cartilage oligomeric matrix protein (pg/mL) between loading conditions

  Chance in cartilage turnover over 20 minute intervention

Study Arms (4)

Overloading

EXPERIMENTAL

Participants will walk on a force-instrumented treadmill for 20 minutes and will be provided visual biofeedback consisting of bilateral vertical ground reaction force. A target will be placed at 10% greater than the participant's baseline vertical ground reaction force. Participants will be asked to alter their walking gait in an attempt to reach the target line with each step.

Other: Real-Time Biofeedback

Underloading

EXPERIMENTAL

Participants will walk on a force-instrumented treadmill for 20 minutes and will be provided visual biofeedback consisting of bilateral vertical ground reaction force. A target will be placed at 10% lower than the participant's baseline vertical ground reaction force. Participants will be asked to alter their walking gait in an attempt to reach the target line with each step.

Other: Real-Time Biofeedback

Average

EXPERIMENTAL

Participants will walk on a force-instrumented treadmill for 20 minutes and will be provided visual biofeedback consisting of bilateral vertical ground reaction force. A target will be placed at the average of each participant's baseline vertical ground reaction force between limbs. Participants will be asked to alter their walking gait in an attempt to reach the target line with each step.

Other: Real-Time Biofeedback

Control

NO INTERVENTION

Participants will walk for 20 minutes on a force-instrumented treadmill and will not be provided biofeedback.

Interventions

Real-Time Biofeedback OTHER

A custom written MatLab script will sample bilateral peak vertical ground reaction forces and display the magnitude in real time on a screen placed in front of the participant. A target line will be placed in the middle of the screen which corresponds to one of the three loading conditions. Participants will be instructed to alter their movement in an attempt to match each limb's vertical ground reaction force to the target line.

Average; Overloading; Underloading

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Have a history of a primary, unilateral ACLR using either a hamstring or patellar tendon autograft, cleared by a physical for full return to physical activity with no limitations, and participate in at least 30 minutes of physical activity 3 times per week

You may not qualify if:

• History of injury to either leg, other than ACLR (e.g. ankle sprain, muscle strain), within 6 months prior to participation in the study, history of lower extremity surgery other than ACLR, history of osteoarthritis or current symptoms related to knee osteoarthritis (e.g. pain, swelling, stiffness), currently pregnant, or planning to become pregnant while enrolled in the study, cardiovascular restrictions that limit the participant's ability to participate in physical activity.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Related Publications (2)

• Luc-Harkey BA, Franz J, Hackney AC, Blackburn JT, Padua DA, Schwartz T, Davis-Wilson H, Spang J, Pietrosimone B. Immediate Biochemical Changes After Gait Biofeedback in Individuals With Anterior Cruciate Ligament Reconstruction. J Athl Train. 2020 Oct 1;55(10):1106-1115. doi: 10.4085/1062-6050-0372.19.

  PMID: 32966563 DERIVED

• Luc-Harkey BA, Franz JR, Blackburn JT, Padua DA, Hackney AC, Pietrosimone B. Real-time biofeedback can increase and decrease vertical ground reaction force, knee flexion excursion, and knee extension moment during walking in individuals with anterior cruciate ligament reconstruction. J Biomech. 2018 Jul 25;76:94-102. doi: 10.1016/j.jbiomech.2018.05.043. Epub 2018 Jun 15.

  PMID: 29921523 DERIVED

Study Officials

• Brian Pietrosimone, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2017
• First Posted: January 30, 2017
• Study Start: July 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: April 1, 2017
• Last Updated: April 19, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share