Gait Rehabilitation to Treat FastOA
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Mean Change from Baseline to Week 6 in Vertical Ground Reaction Force
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 16 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •A multiple ligament surgery (i.e., PCL)
- •A lower extremity fracture (i.e., displaced tibial plateau fracture)
- •Knee osteoarthritis
研究组 & 干预措施
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.
干预措施: Real-time gait biofeedback (Behavioral)
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.
干预措施: Sham real-time gait biofeedback (Behavioral)
结局指标
主要结局
Mean Change from Baseline to Week 6 in Vertical Ground Reaction Force
时间窗: 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
时间窗: 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
时间窗: 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 Week 6 in Tibial Cartilage Strain
时间窗: 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)).
时间窗: 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)).
时间窗: 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 Month 6 in Joint Tissues Metabolism by Assessing Degenerative Matrix Metalloproteinase-1 (MMP-1) Enzyme
时间窗: 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)
时间窗: 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))
时间窗: 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
时间窗: 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
时间窗: 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))
时间窗: 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 Month 6 in the Knee Injury and Osteoarthritis Outcome Quality of Life Subscale Score
时间窗: 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
时间窗: 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-3 (MMP-3) Enzyme
时间窗: 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 Week 6 in Joint Tissues Metabolism by Assessing Degenerative Matrix Metalloproteinase-9 (MMP-9) Enzyme
时间窗: 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)
时间窗: 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
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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 Week 6 in Joint Tissues Metabolism by Assessing a Disintegrin and Metalloproteinase with thrombospondin Motifs-4 (ADAMTS-4)
时间窗: 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 Vertical Ground Reaction Force
时间窗: 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
时间窗: 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)
时间窗: 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 Marker of Cartilage Turnover C-Terminal Crosslinked Telopeptide-II (CTXII)
时间窗: 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.
次要结局
- Change in the International Knee Documentation Committee Subjective Knee Evaluation Form Score(Up to 6 months)
- Change in the Anterior Cruciate Ligament Return to Sport After Injury Scale Score(Up to 6 months)
- Change in the Tegner Activity Scale Score(Up to 6 months)