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

VA Palo Alto Health Care System

Status: Unknown

Conditions: Anterior Cruciate Ligament Reconstruction

Treatments: Device: Active feedback gait retraining

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT03551678

CDMRP-PR171647 (Other Grant/Funding Number)

46025

Details and patient eligibility

About

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.

Enrollment: 45 estimated patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

Gait retraining

Experimental group

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.

Treatment:

Device: Active feedback gait retraining