Optimizing Gait Biomechanics for Posttraumatic Osteoarthritis Prevention

University of North Carolina (UNC)

Status: Completed

Conditions: Knee Injuries; Post-traumatic Osteoarthritis; Anterior Cruciate Ligament Injuries; Cartilage, Articular; Gait; Knee Osteoarthritis

Treatments: Behavioral: Real-time gait biofeedback; Behavioral: Sham real-time gait biofeedback

Study type: Interventional

Funder types: Other

Identifiers

NCT05007366

21-1489a

Details and patient eligibility

About

The purpose of this study is to report the feasibility and determine the initial effects of 18 sessions of real-time gait biofeedback delivered over a 6-week period on retention and transfer of normalized gait biomechanics and improvements in indicators of early post-traumatic osteoarthritis development in those with an anterior cruciate ligament reconstruction (ACLR) at 6 and 8-week posttests.

Enrollment: 24 patients

Sex: All

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have completed all other formal physical therapy
• Are between the ages of 18 and 35
• Underwent an ACLR between 6 and 24 months prior to enrollment.
• Demonstrate underloading during gait (vGRF- impact peak <1.09 x BW)
• Demonstrate clinically relevant-knee symptoms (KOOS-QOL <72)
• Have undergone ACLR surgery

Exclusion criteria

• ACLR revision surgery
• A multiple ligament surgery
• A lower extremity fracture
• Knee osteoarthritis
• The participant has a BMI ≥ 36.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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24 participants in 2 patient groups

Real-time gait biofeedback (RTGBF)

Active Comparator group

Description:

The RTGBF regimen delivers biofeedback that cues a personalized target to normalize vertical ground reaction force (vGRF) of each limb.

Treatment:

Behavioral: Real-time gait biofeedback

Sham real-time gait biofeedback (Sham RTGBF)

Sham Comparator group

Description:

The Sham RTGBF regimen will receive biofeedback that cues their habitual step length determined during the accommodation period on the first session of treadmill walking.

Treatment:

Behavioral: Sham real-time gait biofeedback