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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03551678

Enrollment

Registered

2018-06-11

Start date

2019-06-21

Completion date

2022-12-31

Last updated

2020-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anterior Cruciate Ligament Reconstruction

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.

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 40 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Knee Adduction Moment	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

Measure	Time frame	Description
Medial knee compartment qMRI	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
Knee Adduction Moment	Change from baseline to 3 months after retraining	Knee Joint Loading (%Bw\*Ht)
Serum inflammatory markers	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

Countries

United States

Contacts

Primary ContactJennifer Hledik, PhD

jerhart@stanford.edu650-493-5000

Backup ContactJessica Asay, MS

asay@stanford.edu

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026