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Clinical Trials/NCT03035994
NCT03035994
Completed
Not Applicable

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

University of North Carolina, Chapel Hill0 sites30 target enrollmentJuly 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anterior Cruciate Ligament Reconstruction
Sponsor
University of North Carolina, Chapel Hill
Enrollment
30
Primary Endpoint
Difference in cartilage turnover as measured in serum concentration of cartilage oligomeric matrix protein (pg/mL) between loading conditions
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2016
End Date
April 2017
Last Updated
9 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

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

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

Time Frame: Change in acquisition over 20 minute intervention

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