Effect of Altered Mechanical Loading in ACLR
17 april 2017 bijgewerkt door: University of North Carolina, Chapel Hill
Effect of Altered Mechanical Loading on Lower Extremity Biomechanics and Biochemical Markers in Individuals With an Anterior Cruciate Ligament Reconstruction
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.
Studie Overzicht
Toestand
Voltooid
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
30
Fase
- Niet toepasbaar
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 35 jaar (Volwassen)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Fundamentele wetenschap
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Overloading
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.
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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.
|
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Experimenteel: Underloading
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.
|
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.
|
|
Experimenteel: Average
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.
|
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.
|
|
Geen tussenkomst: Control
Participants will walk for 20 minutes on a force-instrumented treadmill and will not be provided biofeedback.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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Difference in acquisition as measured in root mean square error (RMSE) between loading conditions
Tijdsspanne: Change in acquisition over 20 minute intervention
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Change in acquisition over 20 minute intervention
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Difference in joint loading as measured in peak vertical ground reaction force normalized to body weight (xBW) between loading conditions
Tijdsspanne: Change in joint loading over 20 minute intervention
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Change in joint loading over 20 minute intervention
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Difference in cartilage turnover as measured in serum concentration of cartilage oligomeric matrix protein (pg/mL) between loading conditions
Tijdsspanne: Chance in cartilage turnover over 20 minute intervention
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Chance in cartilage turnover over 20 minute intervention
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Onderzoekers
- Hoofdonderzoeker: Brian Pietrosimone, PhD, University of North Carolina, Chapel Hill
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- 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.
- 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.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 juli 2016
Primaire voltooiing (Werkelijk)
1 februari 2017
Studie voltooiing (Werkelijk)
1 april 2017
Studieregistratiedata
Eerst ingediend
22 januari 2017
Eerst ingediend dat voldeed aan de QC-criteria
26 januari 2017
Eerst geplaatst (Schatting)
30 januari 2017
Updates van studierecords
Laatste update geplaatst (Werkelijk)
19 april 2017
Laatste update ingediend die voldeed aan QC-criteria
17 april 2017
Laatst geverifieerd
1 april 2017
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- 16-0409
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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