Effect of Altered Mechanical Loading in ACLR

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.

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Key information

Conditions

Anterior Cruciate Ligament Reconstruction

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

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

Time frame: 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

Time frame: 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

Time frame: Chance in cartilage turnover over 20 minute intervention

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Registry information

Official study title

Effect of Altered Mechanical Loading on Lower Extremity Biomechanics and Biochemical Markers in Individuals With an Anterior Cruciate Ligament Reconstruction

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2017
First posted: Jan 30, 2017
Registry last updated: Apr 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed