Clinical trial NCT05007366: Optimizing Gait Biomechanics for Posttraumatic Osteoarthritis Prevention
Official title: Optimizing Gait Biomechanics for Posttraumatic Osteoarthritis Prevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anterior Cruciate Ligament Injuries
Post-traumatic Osteoarthritis
Knee Osteoarthritis
Knee Injuries
Cartilage, Articular
Gait
Keywords: Biofeedback
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Arthritis Foundation
First posted: 2021-08-16
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants recruited using different recruitment modes
timeFrame: Baseline (pre-intervention)
measure: The frequency of participant recruitment using different recruitment modes
timeFrame: Baseline (pre-intervention)
measure: Percentage of participants who were successfully enrolled
timeFrame: Baseline (pre-intervention)
measure: Percentage of participants retained
timeFrame: After week 4 and after week 8
measure: Reasons for refusal to enroll
timeFrame: Baseline (pre-intervention)
measure: Number of subjects who adhered to the intervention
timeFrame: About 2 months
Secondary outcomes:
measure: The change in vertical ground reaction force before and after intervention
timeFrame: Up to 2 months
measure: The change in T1ρ MRI relaxation times before and after intervention
timeFrame: Up to 2 months
measure: The change in T1ρ MRI relaxation times in the medial femoral condyle before and after intervention
timeFrame: Up to 2 months
measure: The change in T1ρ MRI relaxation times in the lateral femoral condyle before and after intervention
timeFrame: Up to 2 months
measure: The change in T1ρ MRI relaxation times in the medial tibial condyle before and after intervention
timeFrame: Up to 2 months
measure: The change in T1ρ MRI relaxation times in the lateral tibial condyle before and after intervention
timeFrame: Up to 2 months
measure: The change in the Knee Injury and Osteoarthritis Outcome Quality of Life subscale score
timeFrame: Up to 2 months
measure: The change in the International Knee Documentation Committee Subjective Knee Evaluation form score
timeFrame: Up to 2 months
measure: The change in the Tegner Activity Scale score
timeFrame: Up to 2 months
measure: The change in the Anterior Cruciate Ligament Return to Sport After Injury Scale score
timeFrame: Up to 2 months
measure: The change in the Visual, Aural, Reading/Writing, and Kinesthetic Questionnaire score
timeFrame: Up to 2 months
measure: The change in peak vGRF
timeFrame: Up to 2 months
measure: The change in peak knee flexion excursion
timeFrame: Up to 2 months
measure: The change in peak internal knee extension moment
timeFrame: Up to 2 months
measure: The change in joint tissues metabolism by assessing biomarker chemokine (monocyte chemoattractant protein-1 (MCP-1)).
timeFrame: Up to 2 months
measure: The change in joint tissues metabolism by assessing degenerative matrix metalloproteinase-3 (MMP-3) enzyme.
timeFrame: Up to 2 months
measure: The change in joint tissues metabolism by assessing marker of cartilage turnover (cartilage oligomeric matrix protein (COMP)).
timeFrame: Up to 2 months
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Brian Pietrosimone
role: PRINCIPAL_INVESTIGATOR
References: