Gait Rehabilitation to Treat FastOA

NCT05848622 | Recruiting

• 1 other identifier: 21-1489b
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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; Cartilage, Articular; Gait

Keywords

Biofeedback; FastOA

Outcome Measures

Primary Outcomes (26)

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

  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.

  Baseline, Week 6

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

  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.

  Baseline, Month 6

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

  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.

  Baseline, Week 6

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

  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.

  Baseline, Month 6

• Mean Change from Baseline to Week 6 in Tibial Cartilage Strain

  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.

  Baseline, Week 6

• Mean Change from Baseline to Month 6 in Tibial Cartilage Strain

  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.

  Baseline, Month 6

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

  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.

  Baseline, Week 6

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

  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.

  Baseline, Month 6

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

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

  Baseline, Week 6

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

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

  Baseline, Month 6

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

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

  Baseline, Week 6

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

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

  Baseline, Month 6

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

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

  Baseline, Week 6

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

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

  Baseline, Month 6

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

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

  Baseline, Week 6

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

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

  Baseline, Month 6

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

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

  Baseline, Week 6

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

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

  Baseline, Month 6

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

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

  Baseline, Week 6

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

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

  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)

  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.

  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)

  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.

  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))

  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.

  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))

  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.

  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)

  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.

  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)

  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.

  Baseline, Month 6

Secondary Outcomes (3)

• Change in the International Knee Documentation Committee Subjective Knee Evaluation Form Score

  Up to 6 months

• Change in the Tegner Activity Scale Score

  Up to 6 months

• Change in the Anterior Cruciate Ligament Return to Sport After Injury Scale Score

  Up to 6 months

Study Arms (2)

Real-time gait biofeedback (RTGBF)

ACTIVE COMPARATOR

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

Behavioral: Real-time gait biofeedback

Sham real-time gait biofeedback (Sham RTGBF)

SHAM COMPARATOR

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.

Behavioral: Sham real-time gait biofeedback

Interventions

Real-time gait biofeedback BEHAVIORAL

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.

Real-time gait biofeedback (RTGBF)

Sham real-time gait biofeedback BEHAVIORAL

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.

Sham real-time gait biofeedback (Sham RTGBF)

Eligibility Criteria

• Age: 16 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Arthritis Foundation: collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27516, United States

RECRUITING

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries; Osteoarthritis, Knee; Knee Injuries

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries; Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Brian Pietrosimone, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Natalia Favoreto, MS

CONTACT

9199622025; favoreto@med.unc.edu

Brian Pietrosimone, PhD

CONTACT

19199623617; pietrosi@email.unc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2023
• First Posted: May 8, 2023
• Study Start: June 13, 2023
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: June 22, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Time Frame: 9 to 36 months
• Access Criteria: The investigator who proposes to use the data has approval from an IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

Locations

US (1)