Gait Rehabilitation to Treat FastOA

University of North Carolina (UNC)

Status: Enrolling

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

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05848622

21-1489b

Details and patient eligibility

About

The purpose of this study is to determine the effects of real-time gait biofeedback delivered over a 6-week period on early markers of FastOA and conduct 6-week and 6-month follow-up assessments in anterior cruciate ligament reconstructed patients.

Enrollment: 70 estimated patients

Sex: All

Ages: 16 to 35 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have completed all other formal physical therapy
• Are between the ages of 16 and 35
• Underwent an anterior cruciate ligament reconstruction (ACLR) between 6 and 60 months prior to enrollment
• Demonstrate underloading during gait (vGRF- impact peak <1.12 x BW)

Exclusion criteria

• A multiple ligament surgery (i.e., PCL)
• A lower extremity fracture (i.e., displaced tibial plateau 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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70 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