Gait Rehabilitation to Treat FastOA

Not Applicable

Recruiting

• Conditions: Knee Injuries; Post-traumatic Osteoarthritis; Anterior Cruciate Ligament Injuries; Osteo Arthritis Knee; Cartilage, Articular; Gait; Knee Osteoarthritis
• Interventions: Behavioral: Real-time gait biofeedback; Behavioral: Sham real-time gait biofeedback

• Registration Number: NCT05848622
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-14
• Study First Submitted QC: 2023-04-28
• Study First Posted: 2023-05-08
• Study Start: 2023-06-13
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-02
• Last Update Posted: 2024-08-06
• Primary Completion: 2025-05-08
• Study Completion: 2025-05-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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)

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Real-time gait biofeedback (RTGBF)	Real-time gait biofeedback	The RTGBF regimen delivers biofeedback that cues a personalized target to normalize vertical ground reaction force (vGRF) of each limb.
Sham real-time gait biofeedback (Sham RTGBF)	Sham real-time gait biofeedback	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.

Primary Outcome Measures

Name	Time	Method
Mean Change from Baseline to Week 6 in Vertical Ground Reaction Force	Baseline, 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 Week 6 in Knee Joint Contact Forces	Baseline, 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 Forces	Baseline, 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 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 Tibial Cartilage Strain	Baseline, 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 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 Degenerative Matrix Metalloproteinase-1 (MMP-1) Enzyme	Baseline, 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 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 Tibial Cartilage Strain	Baseline, 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 Month 6 in Joint Tissues Metabolism by Assessing Degenerative Matrix Metalloproteinase-3 (MMP-3) Enzyme	Baseline, 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 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 Degenerative Matrix Metalloproteinase-3 (MMP-3) Enzyme	Baseline, 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 the Knee Injury and Osteoarthritis Outcome Quality of Life Subscale Score	Baseline, 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 Degenerative Matrix Metalloproteinase-1 (MMP-1) Enzyme	Baseline, 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 Week 6 in Joint Tissues Metabolism by Assessing Degenerative Matrix Metalloproteinase-9 (MMP-9) Enzyme	Baseline, 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 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.
Mean Change from Baseline to Month 6 in Joint Tissues Metabolism by Assessing Degenerative Matrix Metalloproteinase-9 (MMP-9) Enzyme	Baseline, 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 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 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 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 Vertical Ground Reaction Force	Baseline, 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 the Knee Injury and Osteoarthritis Outcome Quality of Life Subscale Score	Baseline, 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 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 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 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.

Secondary Outcome Measures

Name	Time	Method
Change in the International Knee Documentation Committee Subjective Knee Evaluation Form Score	Up to 6 months	The International Knee Documentation Committee (IKDC) Subjective Knee Evaluation form is a 10-item survey that determines patient-reported knee-related function. This will be collected at Baseline (pre-intervention), 6-week posttest, and 6-month posttest. A higher score indicates better knee function. Range: 0-100.
Change in the Anterior Cruciate Ligament Return to Sport After Injury Scale Score	Up to 6 months	The Anterior Cruciate Ligament Return to Sport After Injury (ACL-RSI) scale to measure an individual's psychological readiness to return to sport. Range: 0-100 points. A lower score on this questionnaire indicates poorer psychological readiness. This will be collected at Baseline (pre-intervention), 6-week posttest, and 6-month posttest.
Change in the Tegner Activity Scale Score	Up to 6 months	The Tegner Activity Scale (TAS) to quantify activity levels in individuals with ACL injury on an 11-point Likert scale. A higher score indicates a higher level of activity (e.g., a 10 indicates participants compete in professional or collegiate levels of sport on a regular basis while a 0 indicates indicates that participants are unable to complete any sport or recreational activity due to disability). This will be collected at Baseline (pre-intervention), 6-week posttest, and 6-month posttest.

Trial Locations

Locations (1)

University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States