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

Primary Purpose

Anterior Cruciate Ligament Reconstruction

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active feedback gait retraining
Sponsored by
VA Palo Alto Health Care System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anterior Cruciate Ligament Reconstruction

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • VA Palo AltoRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Gait retraining

Arm Description

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.

Outcomes

Primary Outcome Measures

Knee Adduction Moment
Knee Joint Loading (%Bw*Ht) will be assessed at baseline and immediately after gait retraining

Secondary Outcome Measures

Medial knee compartment qMRI
Changes to quantitative MRI measures at 6 months after retraining will be correlated with changes to joint loading
Knee Adduction Moment
Knee Joint Loading (%Bw*Ht)
Knee Adduction Moment
Knee Joint Loading (%Bw*Ht)
Serum inflammatory markers
Changes to serum inflammatory markers immediately after the end of training from baseline will be correlated with changes to joint loading

Full Information

First Posted
May 29, 2018
Last Updated
October 23, 2020
Sponsor
VA Palo Alto Health Care System
Collaborators
United States Department of Defense
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1. Study Identification

Unique Protocol Identification Number
NCT03551678
Brief Title
Gait Retraining to Reduce Joint Loading, Inflammation, and PTOA Risk
Official Title
Novel Strategies to Combat Post-Traumatic Osteoarthritis (PTOA): Gait Retraining to Reduce Joint Loading, Inflammation, and PTOA Risk
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 21, 2019 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
VA Palo Alto Health Care System
Collaborators
United States Department of Defense

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Reconstruction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Gait retraining
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Active feedback gait retraining
Intervention Description
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 Measure Information:
Title
Knee Adduction Moment
Description
Knee Joint Loading (%Bw*Ht) will be assessed at baseline and immediately after gait retraining
Time Frame
Change from baseline to immediately after 8 weeks of retraining
Secondary Outcome Measure Information:
Title
Medial knee compartment qMRI
Description
Changes to quantitative MRI measures at 6 months after retraining will be correlated with changes to joint loading
Time Frame
Change from baseline to 6 months after retraining
Title
Knee Adduction Moment
Description
Knee Joint Loading (%Bw*Ht)
Time Frame
Change from baseline to 3 months after retraining
Title
Knee Adduction Moment
Description
Knee Joint Loading (%Bw*Ht)
Time Frame
Change from baseline to 6 months after retraining
Title
Serum inflammatory markers
Description
Changes to serum inflammatory markers immediately after the end of training from baseline will be correlated with changes to joint loading
Time Frame
Change from baseline to immediately after 8 weeks of retraining

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Hledik, PhD
Phone
650-493-5000
Ext
62388
Email
jerhart@stanford.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jessica Asay, MS
Email
asay@stanford.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Constance Chu, MD
Organizational Affiliation
VAPAHCS and Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Palo Alto
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Constance R Chu, MD
Phone
650-721-7618
Email
chucr@stanford.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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