Recruiting

Gait Retraining

Sponsor:

VA Palo Alto Health Care System

Code:

NCT03551678

Conditions

Anterior Cruciate Ligament Reconstruction

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Not accepted

Interventions

Active feedback gait retraining

Study Details

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.

Conditions

Anterior Cruciate Ligament Reconstruction

Study ID

NCT03551678

Start date

Jun 21, 2019

Status verified date

Oct, 2020

Completion date

Dec 31, 2022

Anticipated

Primary completion date

Dec 31, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Not accepted

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 Design

Enrollment

45 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Active 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.

Primary outcome measure

  • Knee Adduction Moment [ Time Frame: Change from baseline to immediately after 8 weeks of retraining ]

Central Contacts and Locations

Central contacts

Jennifer Hledik, PhD

650-493-5000jerhart@stanford.edu

Jessica Asay, MS

asay@stanford.edu

Locations

VA Palo Alto

Recruiting

Palo Alto, California, United States, 94304

Contacts

Constance R Chu, MD

650-721-7618chucr@stanford.edu

More Information

Sponsor

VA Palo Alto Health Care System

Last update posted

Oct 27, 2020

Last verified

Oct, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Palo Alto Health Care System on 2020-10-27.