Recruiting

Gait Rehabilitation

Sponsor:

University of North Carolina, Chapel Hill

Code:

NCT05848622

Conditions

Anterior Cruciate Ligament Injuries

Post-traumatic Osteoarthritis

Knee Osteoarthritis

Osteo Arthritis Knee

Knee Injuries

Eligibility Criteria

Sex: All

Age: 16 - 35

Healthy Volunteers: Not accepted

Interventions

Real-time gait biofeedback

Sham real-time gait biofeedback

Study Details

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.

Conditions

Anterior Cruciate Ligament Injuries

Post-traumatic Osteoarthritis

Knee Osteoarthritis

Osteo Arthritis Knee

Knee Injuries

Study ID

NCT05848622

Start date

Jun 13, 2023

Status verified date

Jun, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16 - 35

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Real-time gait biofeedback (RTGBF)

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

sham comparator: Sham real-time gait biofeedback (Sham RTGBF)

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.

Interventions

Real-time gait biofeedback

The RTGBF interventions will include eighteen step gait training sessions. The intervention will gradually increase to 3,000 steps at the 5th session with 100% feedback. During the remaining sessions, the intervention will include 3,000 steps, but the feedback will be gradually tapered off starting with the 11th session.

Sham real-time gait biofeedback

The Sham RTGBF interventions will include eighteen step gait training sessions. The intervention will gradually increase to 3,000 steps at the 5th session with 100% feedback. During the remaining sessions, the intervention will include 3,000 steps, but the feedback will be gradually tapered off starting with the 11th session.

Primary outcome measure

  • Mean Change from Baseline to Week 6 in Vertical Ground Reaction Force [ Time Frame: Baseline, Week 6 ]
  • Mean Change from Baseline to Month 6 in Vertical Ground Reaction Force [ Time Frame: Baseline, Month 6 ]
  • Mean Change from Baseline to Week 6 in Knee Joint Contact Forces [ Time Frame: Baseline, Week 6 ]
  • Mean Change from Baseline to Month 6 in Knee Joint Contact Forces [ Time Frame: Baseline, Month 6 ]
  • Mean Change from Baseline to Week 6 in Tibial Cartilage Strain [ Time Frame: Baseline, Week 6 ]
  • Mean Change from Baseline to Month 6 in Tibial Cartilage Strain [ Time Frame: Baseline, Month 6 ]
  • Mean Change from Baseline to Week 6 in the Knee Injury and Osteoarthritis Outcome Quality of Life Subscale Score [ Time Frame: Baseline, Week 6 ]
  • Mean Change from Baseline to Month 6 in the Knee Injury and Osteoarthritis Outcome Quality of Life Subscale Score [ Time Frame: Baseline, Month 6 ]
  • Mean Change from Baseline to Week 6 in Joint Tissues Metabolism by Assessing Biomarker Chemokine (Monocyte Chemoattractant Protein-1 (MCP-1)). [ Time Frame: Baseline, Week 6 ]
  • Mean Change from Baseline to Month 6 in Joint Tissues Metabolism by Assessing Biomarker Chemokine (Monocyte Chemoattractant Protein-1 (MCP-1)). [ Time Frame: Baseline, Month 6 ]
  • Mean Change from Baseline to Week 6 in Joint Tissues Metabolism by Assessing Degenerative Matrix Metalloproteinase-1 (MMP-1) Enzyme [ Time Frame: Baseline, Week 6 ]
  • Mean Change from Baseline to Month 6 in Joint Tissues Metabolism by Assessing Degenerative Matrix Metalloproteinase-1 (MMP-1) Enzyme [ Time Frame: Baseline, Month 6 ]
  • Mean Change from Baseline to Week 6 in Joint Tissues Metabolism by Assessing Degenerative Matrix Metalloproteinase-3 (MMP-3) Enzyme [ Time Frame: Baseline, Week 6 ]
  • Mean Change from Baseline to Month 6 in Joint Tissues Metabolism by Assessing Degenerative Matrix Metalloproteinase-3 (MMP-3) Enzyme [ Time Frame: Baseline, Month 6 ]
  • Mean Change from Baseline to Week 6 in Joint Tissues Metabolism by Assessing Degenerative Matrix Metalloproteinase-9 (MMP-9) Enzyme [ Time Frame: Baseline, Week 6 ]
  • Mean Change from Baseline to Month 6 in Joint Tissues Metabolism by Assessing Degenerative Matrix Metalloproteinase-9 (MMP-9) Enzyme [ Time Frame: Baseline, Month 6 ]
  • Mean Change from Baseline to Week 6 in Joint Tissues Metabolism by Assessing the Inflammatory Response via Interleukin 6 (IL-6) [ Time Frame: Baseline, Week 6 ]
  • Mean Change from Baseline to Month 6 in Joint Tissues Metabolism by Assessing the Inflammatory Response via Interleukin 6 (IL-6) [ Time Frame: Baseline, Month 6 ]
  • Mean Change from Baseline to Week 6 in Joint Tissues Metabolism by Assessing Tumor Necrosis Factor Alpha (TNF-Alpha) [ Time Frame: Baseline, Week 6 ]
  • Mean Change from Baseline to Month 6 in Joint Tissues Metabolism by Assessing Tumor Necrosis Factor Alpha (TNF-Alpha) [ Time Frame: Baseline, Month 6 ]
  • Mean Change from Baseline to Week 6 in Joint Tissues Metabolism by Assessing a Disintegrin and Metalloproteinase with thrombospondin Motifs-4 (ADAMTS-4) [ Time Frame: Baseline, Week 6 ]
  • Mean Change from Baseline to Month 6 in Joint Tissues Metabolism by Assessing a Disintegrin and Metalloproteinase with thrombospondin Motifs-4 (ADAMTS-4) [ Time Frame: Baseline, Month 6 ]
  • Mean Change from Baseline to Week 6 in Joint Tissues Metabolism by Assessing a Marker of Cartilage Turnover (Cartilage Oligomeric Matrix Protein (COMP)) [ Time Frame: Baseline, Week 6 ]
  • Mean Change from Baseline to Month 6 in Joint Tissues Metabolism by Assessing a Marker of Cartilage Turnover (Cartilage Oligomeric Matrix Protein (COMP)) [ Time Frame: Baseline, Month 6 ]
  • Mean Change from Baseline to Week 6 in Joint Tissues Metabolism by Assessing a Marker of Cartilage Turnover C-Terminal Crosslinked Telopeptide-II (CTXII) [ Time Frame: Baseline, Week 6 ]
  • Mean Change from Baseline to Month 6 in Joint Tissues Metabolism by Assessing a Marker of Cartilage Turnover C-Terminal Crosslinked Telopeptide-II (CTXII) [ Time Frame: Baseline, Month 6 ]

Central Contacts and Locations

Central contacts

Natalia Favoreto, MS

9199622025favoreto@med.unc.edu

Brian Pietrosimone, PhD

19199623617pietrosi@email.unc.edu

Locations

University of North Carolina at Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27516

More Information

Sponsor

University of North Carolina, Chapel Hill

Last update posted

Jun 25, 2026

Last verified

Jun, 2026

Keywords

  • Biofeedback
  • FastOA

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of North Carolina, Chapel Hill on 2026-06-25.