Clinical trial NCT05848622: Gait Rehabilitation to Treat FastOA
Official title: Gait Rehabilitation to Treat FastOA
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anterior Cruciate Ligament Injuries
Post-traumatic Osteoarthritis
Knee Osteoarthritis
Osteo Arthritis Knee
Knee Injuries
Cartilage, Articular
Gait
Keywords: Biofeedback
FastOA
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Arthritis Foundation
First posted: 2023-05-08
Enrollment: 70
Sex: ALL
Minimum age (years): 16
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Mean Change from Baseline to Week 6 in Vertical Ground Reaction Force
timeFrame: Baseline, Week 6
measure: Mean Change from Baseline to Month 6 in Vertical Ground Reaction Force
timeFrame: Baseline, Month 6
measure: Mean Change from Baseline to Week 6 in Knee Joint Contact Forces
timeFrame: Baseline, Week 6
measure: Mean Change from Baseline to Month 6 in Knee Joint Contact Forces
timeFrame: Baseline, Month 6
measure: Mean Change from Baseline to Week 6 in Tibial Cartilage Strain
timeFrame: Baseline, Week 6
measure: Mean Change from Baseline to Month 6 in Tibial Cartilage Strain
timeFrame: Baseline, Month 6
measure: Mean Change from Baseline to Week 6 in the Knee Injury and Osteoarthritis Outcome Quality of Life Subscale Score
timeFrame: Baseline, Week 6
measure: Mean Change from Baseline to Month 6 in the Knee Injury and Osteoarthritis Outcome Quality of Life Subscale Score
timeFrame: Baseline, Month 6
measure: Mean Change from Baseline to Week 6 in Joint Tissues Metabolism by Assessing Biomarker Chemokine (Monocyte Chemoattractant Protein-1 (MCP-1)).
timeFrame: Baseline, Week 6
measure: Mean Change from Baseline to Month 6 in Joint Tissues Metabolism by Assessing Biomarker Chemokine (Monocyte Chemoattractant Protein-1 (MCP-1)).
timeFrame: Baseline, Month 6
measure: Mean Change from Baseline to Week 6 in Joint Tissues Metabolism by Assessing Degenerative Matrix Metalloproteinase-1 (MMP-1) Enzyme
timeFrame: Baseline, Week 6
measure: Mean Change from Baseline to Month 6 in Joint Tissues Metabolism by Assessing Degenerative Matrix Metalloproteinase-1 (MMP-1) Enzyme
timeFrame: Baseline, Month 6
measure: Mean Change from Baseline to Week 6 in Joint Tissues Metabolism by Assessing Degenerative Matrix Metalloproteinase-3 (MMP-3) Enzyme
timeFrame: Baseline, Week 6
measure: Mean Change from Baseline to Month 6 in Joint Tissues Metabolism by Assessing Degenerative Matrix Metalloproteinase-3 (MMP-3) Enzyme
timeFrame: Baseline, Month 6
measure: Mean Change from Baseline to Week 6 in Joint Tissues Metabolism by Assessing Degenerative Matrix Metalloproteinase-9 (MMP-9) Enzyme
timeFrame: Baseline, Week 6
measure: Mean Change from Baseline to Month 6 in Joint Tissues Metabolism by Assessing Degenerative Matrix Metalloproteinase-9 (MMP-9) Enzyme
timeFrame: Baseline, Month 6
measure: Mean Change from Baseline to Week 6 in Joint Tissues Metabolism by Assessing the Inflammatory Response via Interleukin 6 (IL-6)
timeFrame: Baseline, Week 6
measure: Mean Change from Baseline to Month 6 in Joint Tissues Metabolism by Assessing the Inflammatory Response via Interleukin 6 (IL-6)
timeFrame: Baseline, Month 6
measure: Mean Change from Baseline to Week 6 in Joint Tissues Metabolism by Assessing Tumor Necrosis Factor Alpha (TNF-Alpha)
timeFrame: Baseline, Week 6
measure: Mean Change from Baseline to Month 6 in Joint Tissues Metabolism by Assessing Tumor Necrosis Factor Alpha (TNF-Alpha)
timeFrame: Baseline, Month 6
measure: Mean Change from Baseline to Week 6 in Joint Tissues Metabolism by Assessing a Disintegrin and Metalloproteinase with thrombospondin Motifs-4 (ADAMTS-4)
timeFrame: Baseline, Week 6
measure: Mean Change from Baseline to Month 6 in Joint Tissues Metabolism by Assessing a Disintegrin and Metalloproteinase with thrombospondin Motifs-4 (ADAMTS-4)
timeFrame: Baseline, Month 6
measure: Mean Change from Baseline to Week 6 in Joint Tissues Metabolism by Assessing a Marker of Cartilage Turnover (Cartilage Oligomeric Matrix Protein (COMP))
timeFrame: Baseline, Week 6
measure: Mean Change from Baseline to Month 6 in Joint Tissues Metabolism by Assessing a Marker of Cartilage Turnover (Cartilage Oligomeric Matrix Protein (COMP))
timeFrame: Baseline, Month 6
measure: Mean Change from Baseline to Week 6 in Joint Tissues Metabolism by Assessing a Marker of Cartilage Turnover C-Terminal Crosslinked Telopeptide-II (CTXII)
timeFrame: Baseline, Week 6
measure: Mean Change from Baseline to Month 6 in Joint Tissues Metabolism by Assessing a Marker of Cartilage Turnover C-Terminal Crosslinked Telopeptide-II (CTXII)
timeFrame: Baseline, Month 6
Secondary outcomes:
measure: Change in the International Knee Documentation Committee Subjective Knee Evaluation Form Score
timeFrame: Up to 6 months
measure: Change in the Tegner Activity Scale Score
timeFrame: Up to 6 months
measure: Change in the Anterior Cruciate Ligament Return to Sport After Injury Scale Score
timeFrame: Up to 6 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, PhD
role: PRINCIPAL_INVESTIGATOR
References: