Gait Retraining to Reduce Joint Loading, Inflammation, and PTOA Risk
Novel Strategies to Combat Post-Traumatic Osteoarthritis (PTOA): Gait Retraining to Reduce Joint Loading, Inflammation, and PTOA Risk
2 other identifiers
interventional
45
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 29, 2018
CompletedFirst Posted
Study publicly available on registry
June 11, 2018
CompletedStudy Start
First participant enrolled
June 21, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedOctober 27, 2020
October 1, 2020
3.5 years
May 29, 2018
October 23, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Knee Adduction Moment
Knee Joint Loading (%Bw\*Ht) will be assessed at baseline and immediately after gait retraining
Change from baseline to immediately after 8 weeks of retraining
Secondary Outcomes (4)
Medial knee compartment qMRI
Change from baseline to 6 months after retraining
Knee Adduction Moment
Change from baseline to 3 months after retraining
Knee Adduction Moment
Change from baseline to 6 months after retraining
Serum inflammatory markers
Change from baseline to immediately after 8 weeks of retraining
Study Arms (1)
Gait retraining
EXPERIMENTALEight 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VA Palo Alto
Palo Alto, California, 94304, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Constance Chu, MD
VAPAHCS and Stanford University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- FED
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Study Principal Investigator
Study Record Dates
First Submitted
May 29, 2018
First Posted
June 11, 2018
Study Start
June 21, 2019
Primary Completion
December 31, 2022
Study Completion
December 31, 2022
Last Updated
October 27, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will not share