Clinical trial NCT03035994: Effect of Altered Mechanical Loading in ACLR
Official title: Effect of Altered Mechanical Loading on Lower Extremity Biomechanics and Biochemical Markers in Individuals With an Anterior Cruciate Ligament Reconstruction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anterior Cruciate Ligament Reconstruction
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2017-01-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

Detailed description: Participants will attend 4 testing sessions. Lower extremity biomechanical outcomes and blood samples will be taken before and following the participant walking at a self-selected speed for 20 minutes. During the 20 minutes of treadmill walking real-time biofeedback will be displayed in an attempt to alter mechanical loading. Participants will complete a control, overloading, under-loading, average loading testing session. Order of loading condition will be randomized.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Difference in acquisition as measured in root mean square error (RMSE) between loading conditions
timeFrame: Change in acquisition over 20 minute intervention
measure: Difference in joint loading as measured in peak vertical ground reaction force normalized to body weight (xBW) between loading conditions
timeFrame: Change in joint loading over 20 minute intervention
measure: Difference in cartilage turnover as measured in serum concentration of cartilage oligomeric matrix protein (pg/mL) between loading conditions
timeFrame: Chance in cartilage turnover over 20 minute intervention
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Brian Pietrosimone, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.