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Gait Rehabilitation for Post-traumatic Osteoarthritis After ACL Surgery

This study is looking at how real-time gait biofeedback (RTGBF) can help people who have had anterior cruciate ligament (ACL) reconstruction surgery. RTGBF uses special equipment to give you immediate feedback on how you are walking. The goal is to see if this training can reduce early signs of post-traumatic osteoarthritis (FastOA) in your knee. You might be able to join if you are between 16 and 35 years old, had ACL surgery 6 to 60 months ago, and have finished other physical therapy. Researchers will measure changes in how much force your leg puts on the ground and in your knee joints to see if the training is successful. The study plans to enroll 70 participants, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It will involve 70 participants.
What's involved
You would participate in eighteen gait training sessions over 6 weeks. There will also be follow-up assessments at 6 weeks and 6 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 6 months after the intervention.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05848622

Gait Rehabilitation to Treat FastOA

Recruiting
NAAges 16–35InterventionalPrevention
University of North Carolina, Chapel Hill
~70 participants
Updated 2026-06-25 on ClinicalTrials.gov
What's tested:Real-time gait biofeedbackSham real-time gait biofeedback

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Mean Change from Baseline to Week 6 in Vertical Ground Reaction Force
Measured over Baseline, Week 6
+25 more outcomes measured

Conditions

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

Explore related trials

FastOAInjury of anterior cruciate ligamentOsteoarthritis of kneePost traumatic osteoarthritis

Where it's being run

1 sites across 1 states
North Carolina1

Study leadership

  • Brian Pietrosimone, PhD · PRINCIPAL_INVESTIGATOR · University of North Carolina, Chapel Hill

Who to contact

Natalia Favoreto, MS
[email protected]
9199622025
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Mean Change from Baseline to Week 6 in Vertical Ground Reaction ForceBaseline, Week 6

    Participants walk on a dual-belt force-sensing treadmill for 3000 steps while vertical ground reaction forces are collected. Change score (Post-Pre) loading rate calculated as the peak of the first time derivative of the vertical ground reaction force time series curve during the first 50% of the stance phase. This will be collected at Baseline (pre-intervention) and 6 weeks posttest. An increase in vertical ground reaction force at 6 weeks from baseline indicates improved gait mechanics.

  • Mean Change from Baseline to Month 6 in Vertical Ground Reaction ForceBaseline, Month 6

    Participants walk on a dual-belt force-sensing treadmill for 3000 steps while vertical ground reaction forces are collected. Change score (Post-Pre) loading rate calculated as the peak of the first time derivative of the vertical ground reaction force time series curve during the first 50% of the stance phase. This will be collected at Baseline (pre-intervention) and 6 months posttest. An increase in vertical ground reaction force at 6 months from baseline indicates improved gait mechanics.

  • Mean Change from Baseline to Week 6 in Knee Joint Contact ForcesBaseline, Week 6

    Participants walked on a dual-belt force-sensing treadmill for 3000 steps while lower limb kinematics and kinetics were collected. Walking kinematics and kinetics are submitted to musculoskeletal modeling simulations used to determine the magnitude and location of knee joint contact forces. Change score (post-pre) joint contact forces during the first 50% of the stance phase will be calculated. This will be collected at Baseline (pre-intervention) and 6 weeks posttest. An increase in vertical ground reaction force at 6 weeks from baseline indicates improved gait mechanics.

  • Mean Change from Baseline to Month 6 in Knee Joint Contact ForcesBaseline, Month 6

    Participants walked on a dual-belt force-sensing treadmill for 3000 steps while lower limb kinematics and kinetics were collected. Walking kinematics and kinetics are submitted to musculoskeletal modeling simulations used to determine the magnitude and location of knee joint contact forces. Change score (post-pre) joint contact forces during the first 50% of the stance phase will be calculated. This will be collected at Baseline (pre-intervention) and 6 months posttest. An increase in vertical ground reaction force at 6 months from baseline indicates improved gait mechanics.

  • Mean Change from Baseline to Week 6 in Tibial Cartilage StrainBaseline, Week 6

    MRI imaging provided measures of tibial cartilage thickness before and after a standardized walking protocol that were used to measure cartilage strain. The articular cartilage is viscoelastic, and cartilage strain refers to the deformation profiles of the articular cartilage after applying a load. This will be collected at Baseline (pre-intervention) and 6 weeks posttest. More defuse cartilage strain across the knee joint reflects a better outcome.

  • Mean Change from Baseline to Month 6 in Tibial Cartilage StrainBaseline, Month 6

    MRI imaging provided measures of tibial cartilage thickness before and after a standardized walking protocol that were used to measure cartilage strain. The articular cartilage is viscoelastic, and cartilage strain refers to the deformation profiles of the articular cartilage after applying a load. This will be collected at Baseline (pre-intervention) and 6 months posttest. More defuse cartilage strain across the knee joint reflects a better outcome.

  • Mean Change from Baseline to Week 6 in the Knee Injury and Osteoarthritis Outcome Quality of Life Subscale ScoreBaseline, Week 6

    Knee injury Osteoarthritis Outcome Score (KOOS) Quality of Life subscale to measure knee-related quality of life at pre-intervention (baseline). This will be collected at Baseline (pre-intervention) and 6 weeks posttest. A higher score indicates better knee-related quality of life. Range: 0-100.

  • Mean Change from Baseline to Month 6 in the Knee Injury and Osteoarthritis Outcome Quality of Life Subscale ScoreBaseline, Month 6

    Knee injury Osteoarthritis Outcome Score (KOOS) Quality of Life subscale to measure knee-related quality of life at pre-intervention (baseline). This will be collected at Baseline (pre-intervention) and 6 months posttest. A higher score indicates better knee-related quality of life. Range: 0-100.

  • Mean Change from Baseline to Week 6 in Joint Tissues Metabolism by Assessing Biomarker Chemokine (Monocyte Chemoattractant Protein-1 (MCP-1)).Baseline, Week 6

    Blood for serum-based biomarker chemokine (monocyte chemoattractant protein-1 (MCP-1)). This will be collected at Baseline (pre-intervention) and 6 weeks posttest.

  • Mean Change from Baseline to Month 6 in Joint Tissues Metabolism by Assessing Biomarker Chemokine (Monocyte Chemoattractant Protein-1 (MCP-1)).Baseline, Month 6

    Blood for serum-based biomarker chemokine (monocyte chemoattractant protein-1 (MCP-1)). This will be collected at Baseline (pre-intervention) and 6 months posttest.

  • Mean Change from Baseline to Week 6 in Joint Tissues Metabolism by Assessing Degenerative Matrix Metalloproteinase-1 (MMP-1) EnzymeBaseline, Week 6

    Blood for serum-based biomarker degenerative matrix metalloproteinase-1 (MMP-1) enzyme. This will be collected at Baseline (pre-intervention) and 6 weeks posttest.

  • Mean Change from Baseline to Month 6 in Joint Tissues Metabolism by Assessing Degenerative Matrix Metalloproteinase-1 (MMP-1) EnzymeBaseline, Month 6

    Blood for serum-based biomarker degenerative matrix metalloproteinase-1 (MMP-1) enzyme. This will be collected at Baseline (pre-intervention) and 6 months posttest.

  • Mean Change from Baseline to Week 6 in Joint Tissues Metabolism by Assessing Degenerative Matrix Metalloproteinase-3 (MMP-3) EnzymeBaseline, Week 6

    Blood for serum-based biomarker degenerative matrix metalloproteinase-3 (MMP-3) enzyme. This will be collected at Baseline (pre-intervention) and 6 weeks posttest.

  • Mean Change from Baseline to Month 6 in Joint Tissues Metabolism by Assessing Degenerative Matrix Metalloproteinase-3 (MMP-3) EnzymeBaseline, Month 6

    Blood for serum-based biomarker degenerative matrix metalloproteinase-3 (MMP-3) enzyme. This will be collected at Baseline (pre-intervention) and 6 months posttest.

  • Mean Change from Baseline to Week 6 in Joint Tissues Metabolism by Assessing Degenerative Matrix Metalloproteinase-9 (MMP-9) EnzymeBaseline, Week 6

    Blood for serum-based biomarker degenerative matrix metalloproteinase-9 (MMP-9) enzyme. This will be collected at Baseline (pre-intervention) and 6 weeks posttest.

  • Mean Change from Baseline to Month 6 in Joint Tissues Metabolism by Assessing Degenerative Matrix Metalloproteinase-9 (MMP-9) EnzymeBaseline, Month 6

    Blood for serum-based biomarker degenerative matrix metalloproteinase-9 (MMP-9) enzyme. This will be collected at Baseline (pre-intervention) and 6 months posttest.

  • Mean Change from Baseline to Week 6 in Joint Tissues Metabolism by Assessing the Inflammatory Response via Interleukin 6 (IL-6)Baseline, Week 6

    Blood for serum-based biomarker interleukin 6 (IL-6). This will be collected at Baseline (pre-intervention) and 6 weeks posttest.

  • Mean Change from Baseline to Month 6 in Joint Tissues Metabolism by Assessing the Inflammatory Response via Interleukin 6 (IL-6)Baseline, Month 6

    Blood for serum-based biomarker interleukin 6 (IL-6). This will be collected at Baseline (pre-intervention) and 6 months posttest.

  • Mean Change from Baseline to Week 6 in Joint Tissues Metabolism by Assessing Tumor Necrosis Factor Alpha (TNF-Alpha)Baseline, Week 6

    Blood for serum-based biomarker Tumor Necrosis Factor Alpha (TNF-Alpha). This will be collected at Baseline (pre-intervention) and 6 weeks posttest.

  • Mean Change from Baseline to Month 6 in Joint Tissues Metabolism by Assessing Tumor Necrosis Factor Alpha (TNF-Alpha)Baseline, Month 6

    Blood for serum-based biomarker Tumor Necrosis Factor Alpha (TNF-Alpha). This will be collected at Baseline (pre-intervention) and 6 months posttest.

  • Mean Change from Baseline to Week 6 in Joint Tissues Metabolism by Assessing a Disintegrin and Metalloproteinase with thrombospondin Motifs-4 (ADAMTS-4)Baseline, Week 6

    Blood for serum-based biomarker a disintegrin and metalloproteinase with thrombospondin motifs-4 (ADAMTS-4). This will be collected at Baseline (pre-intervention) and 6 weeks posttest.

  • Mean Change from Baseline to Month 6 in Joint Tissues Metabolism by Assessing a Disintegrin and Metalloproteinase with thrombospondin Motifs-4 (ADAMTS-4)Baseline, Month 6

    Blood for serum-based biomarker a disintegrin and metalloproteinase with thrombospondin motifs-4 (ADAMTS-4). This will be collected at Baseline (pre-intervention) and 6 months posttest.

  • Mean Change from Baseline to Week 6 in Joint Tissues Metabolism by Assessing a Marker of Cartilage Turnover (Cartilage Oligomeric Matrix Protein (COMP))Baseline, Week 6

    Blood for serum-based biomarker marker of cartilage turnover (cartilage oligomeric matrix protein (COMP)). This will be collected at Baseline (pre-intervention) and 6 weeks posttest.

  • Mean Change from Baseline to Month 6 in Joint Tissues Metabolism by Assessing a Marker of Cartilage Turnover (Cartilage Oligomeric Matrix Protein (COMP))Baseline, Month 6

    Blood for serum-based biomarker marker of cartilage turnover (cartilage oligomeric matrix protein (COMP)). This will be collected at Baseline (pre-intervention) and 6 months posttest.

  • Mean Change from Baseline to Week 6 in Joint Tissues Metabolism by Assessing a Marker of Cartilage Turnover C-Terminal Crosslinked Telopeptide-II (CTXII)Baseline, Week 6

    Urine for urine-based biomarker marker of cartilage degradation C-terminal crosslinked telopeptide-II (CTXII). This will be collected at Baseline (pre-intervention) and 6 weeks posttest.

  • Mean Change from Baseline to Month 6 in Joint Tissues Metabolism by Assessing a Marker of Cartilage Turnover C-Terminal Crosslinked Telopeptide-II (CTXII)Baseline, Month 6

    Urine for urine-based biomarker marker of cartilage degradation C-terminal crosslinked telopeptide-II (CTXII). This will be collected at Baseline (pre-intervention) and 6 months posttest.