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

Not Applicable

• Conditions: Anterior Cruciate Ligament Reconstruction
• Interventions: Device: Active feedback gait retraining

• Registration Number: NCT03551678
• Lead Sponsor: VA Palo Alto Health Care System

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-05-29
• Study First Submitted QC: 2018-05-29
• Study First Posted: 2018-06-11
• Study Start: 2019-06-21
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-23
• Last Update Posted: 2020-10-27
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Gait retraining	Active feedback 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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
Knee Adduction Moment	Change from baseline to 6 months after retraining	Knee Joint Loading (%Bw\*Ht)

Trial Locations

Locations (1)

VA Palo Alto; 🇺🇸 Palo Alto, California, United States