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Gait Retraining to Reduce Joint Loading, Inflammation, and PTOA Risk

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ClinicalTrials.gov Identifier: NCT03551678
Recruitment Status : Recruiting
First Posted : June 11, 2018
Last Update Posted : October 27, 2020
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Constance Chu, MD, VA Palo Alto Health Care System

Brief Summary:
The purpose of this study is to determine changes to knee joint loading, biological markers, and cartilage structure following a novel active feedback gait retraining program in anterior cruciate ligament reconstructed patients.

Condition or disease Intervention/treatment Phase
Anterior Cruciate Ligament Reconstruction Device: Active feedback gait retraining Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Novel Strategies to Combat Post-Traumatic Osteoarthritis (PTOA): Gait Retraining to Reduce Joint Loading, Inflammation, and PTOA Risk
Actual Study Start Date : June 21, 2019
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Gait retraining
Eight weeks of active-feedback gait retraining. The gait retraining device measures pressure/force under the lateral side of the foot and activates vibration if loading crosses a set threshold. The location of the vibration is customized for each subject to achieve maximal sensitivity.
Device: Active feedback gait retraining
The device measures pressure/force under the lateral side of the foot and activates vibration if loading crosses a set threshold. The location of the vibration is customized for each subject to achieve maximal sensitivity.




Primary Outcome Measures :
  1. Knee Adduction Moment [ Time Frame: Change from baseline to immediately after 8 weeks of retraining ]
    Knee Joint Loading (%Bw*Ht) will be assessed at baseline and immediately after gait retraining


Secondary Outcome Measures :
  1. Medial knee compartment qMRI [ Time Frame: Change from baseline to 6 months after retraining ]
    Changes to quantitative MRI measures at 6 months after retraining will be correlated with changes to joint loading

  2. Knee Adduction Moment [ Time Frame: Change from baseline to 3 months after retraining ]
    Knee Joint Loading (%Bw*Ht)

  3. Knee Adduction Moment [ Time Frame: Change from baseline to 6 months after retraining ]
    Knee Joint Loading (%Bw*Ht)

  4. Serum inflammatory markers [ Time Frame: Change from baseline to immediately after 8 weeks of retraining ]
    Changes to serum inflammatory markers immediately after the end of training from baseline will be correlated with changes to joint loading



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age 18-40 years
  • history of primary ACLR with or without meniscal repair
  • full weight-bearing status
  • neutral to varus knee alignment
  • plans to remain in the area for at least 8 months.

Exclusion Criteria:

  • Kellgren-Lawrence (KL) radiographic grade > 2
  • additional injury or surgery to the involved knee
  • BMI >30 kg/m2
  • use of walking, orthopedic, or prosthetic assistive device
  • pregnancy
  • inability to have MRI

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03551678


Contacts
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Contact: Jennifer Hledik, PhD 650-493-5000 ext 62388 jerhart@stanford.edu
Contact: Jessica Asay, MS asay@stanford.edu

Locations
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United States, California
VA Palo Alto Recruiting
Palo Alto, California, United States, 94304
Contact: Constance R Chu, MD    650-721-7618    chucr@stanford.edu   
Sponsors and Collaborators
VA Palo Alto Health Care System
United States Department of Defense
Investigators
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Principal Investigator: Constance Chu, MD VAPAHCS and Stanford University
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Responsible Party: Constance Chu, MD, Study Principal Investigator, VA Palo Alto Health Care System
ClinicalTrials.gov Identifier: NCT03551678    
Other Study ID Numbers: 46025
CDMRP-PR171647 ( Other Grant/Funding Number: DoD )
First Posted: June 11, 2018    Key Record Dates
Last Update Posted: October 27, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Additional relevant MeSH terms:
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Inflammation
Pathologic Processes