CClinicalTrials.gg
Status unknownNCT03551678Updated Oct 27, 2020

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

An interventional study of Active feedback gait retraining in Anterior Cruciate Ligament Reconstruction, sponsored by VA Palo Alto Health Care System. Status unknown at 1 site in United States. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2020-10-27.

Sponsored by VA Palo Alto Health Care System · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Not applicable
Ages
18 Years to 40 Years
Sex
All
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Study 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.

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Conditions studied

  • Anterior Cruciate Ligament Reconstruction

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03

In context

Inflammation

3,439 studies on the registry are indexed under Inflammation; 629 are open to participants now.

This study's planned enrollment of 45 is close to the median of 50 across 2,437 interventional studies indexed under Inflammation.

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Lead sponsor

VA Palo Alto Health Care System is the lead sponsor of 42 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
45 participants (estimated)

Study arms

  • 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

Interventions

  • DeviceActive 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.

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What researchers measure

Primary outcomes

  1. Knee Adduction Moment

    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 outcomes

  1. Medial knee compartment qMRI

    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

  2. Knee Adduction Moment

    Knee Joint Loading (%Bw\*Ht)

    Time frame: Change from baseline to 3 months after retraining

  3. Knee Adduction Moment

    Knee Joint Loading (%Bw\*Ht)

    Time frame: Change from baseline to 6 months after retraining

  4. Serum inflammatory markers

    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

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Study locations

1 of 1 sites recruiting
  • VA Palo Alto
    Palo Alto, California 94304, United States
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 27, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03551678
Lead sponsor
VA Palo Alto Health Care System
Collaborators
United States Department of Defense
Responsible party
Constance Chu, MD (Study Principal Investigator, VA Palo Alto Health Care System) — Principal investigator
First posted
Jun 11, 2018
Start date
Jun 21, 2019
Primary completion
Dec 31, 2022 (estimated)
Completion
Dec 31, 2022 (estimated)
Last update
Oct 27, 2020

Study contacts

Jennifer Hledik, PhD
Contact
jerhart@stanford.edu
650-493-5000 ext. 62388
Jessica Asay, MS
Contact
asay@stanford.edu
Constance Chu, MD
principal investigator · VAPAHCS and Stanford University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.

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