Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Palo Alto, California 94304


Purpose:

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.


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


Study is Available At:


Original ID:

46025


NCT ID:

NCT03551678


Secondary ID:

CDMRP-PR171647


Study Acronym:


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


Overall Status:

Not yet recruiting


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

40 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

VA Palo Alto Health Care System


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

45


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Constance Chu, MD
Principal Investigator
VAPAHCS and Stanford University
Primary Contact:Jennifer Hledik, PhD
650-493-5000 ext. 62388
650-493-5000
jerhart@stanford.edu
Backup Contact:Jessica Asay, MS
asay@stanford.edu

Study Dates

Start Date:September 1, 2018
Completion Date:December 31, 2022
Completion Type:Anticipated
Primary Completion Date:December 31, 2022
Primary Completion Type:Anticipated
Verification Date:June 2018
Last Changed Date:June 12, 2018
First Received Date:May 29, 2018

Study Outcomes

Outcome Type:Primary Outcome
Measure:Knee Adduction Moment
Time Frame:Change from baseline to immediately after 8 weeks of retraining
Safety Issues:False
Description:Knee Joint Loading (%Bw*Ht) will be assessed at baseline and immediately after gait retraining
Outcome Type:Secondary Outcome
Measure:Medial knee compartment qMRI
Time Frame:Change from baseline to 6 months after retraining
Safety Issues:False
Description:Changes to quantitative MRI measures at 6 months after retraining will be correlated with changes to joint loading
Outcome Type:Secondary Outcome
Measure:Knee Adduction Moment
Time Frame:Change from baseline to 3 months after retraining
Safety Issues:False
Description:Knee Joint Loading (%Bw*Ht)
Outcome Type:Secondary Outcome
Measure:Knee Adduction Moment
Time Frame:Change from baseline to 6 months after retraining
Safety Issues:False
Description:Knee Joint Loading (%Bw*Ht)
Outcome Type:Secondary Outcome
Measure:Serum inflammatory markers
Time Frame:Change from baseline to immediately after 8 weeks of retraining
Safety Issues:False
Description:Changes to serum inflammatory markers immediately after the end of training from baseline will be correlated with changes to joint loading

Study Interventions

Intervention Type:Device
Name:Active feedback gait retraining
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.
Arm Name:Gait retraining

Study Arms

Study Arm Type:Experimental
Arm Name:Gait retraining
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.

Study Agencies

Agency Class:U.S. Fed
Agency Type:Lead Sponsor
Agency Name:VA Palo Alto Health Care System
Agency Class:U.S. Fed
Agency Type:Collaborator
Agency Name:United States Department of Defense

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.