Optimizing Gait Biomechanics for Posttraumatic Osteoarthritis Prevention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Number of participants recruited using different recruitment modes
研究概览
简要总结
The purpose of this study is to report the feasibility and determine the initial effects of 18 sessions of real-time gait biofeedback delivered over a 6-week period on retention and transfer of normalized gait biomechanics and improvements in indicators of early post-traumatic osteoarthritis development in those with an anterior cruciate ligament reconstruction (ACLR) at 6 and 8-week posttests.
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
- 18 Years 至 35 Years（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 18 and 35
- •Underwent an ACLR between 6 and 24 months prior to enrollment.
- •Demonstrate underloading during gait (vGRF- impact peak <1.09 x BW)
- •Demonstrate clinically relevant-knee symptoms (KOOS-QOL <72)
- •Have undergone ACLR surgery
排除标准
- •ACLR revision surgery
- •A multiple ligament surgery
- •A lower extremity fracture
- •Knee osteoarthritis
- •The participant has a BMI ≥ 36.
结局指标
主要结局
Number of participants recruited using different recruitment modes
时间窗: Baseline (pre-intervention)
The investigators will record the number of participants who were recruited, the frequency at which they were recruited, and where they were recruited from. Range 0-70. Higher number indicates more completion.
The frequency of participant recruitment using different recruitment modes
时间窗: Baseline (pre-intervention)
The investigators will record the number of participants who were recruited, the frequency at which they were recruited, and where they were recruited from. Range 0-70. Higher number indicates more completion.
Percentage of participants who were successfully enrolled
时间窗: Baseline (pre-intervention)
The investigators will record the number of participants who were successfully enrolled compared to the total number of participants screened. Range: 0-100. Higher percentage indicates more enrollment.
Percentage of participants retained
时间窗: After week 4 and after week 8
Investigators will record the percentage of patients retained at each monthly data capture timepoint.
Reasons for refusal to enroll
时间窗: Baseline (pre-intervention)
Investigators will record the reasons participants opt not to enroll in the study to determine whether there is a trend.
Number of subjects who adhered to the intervention
时间窗: About 2 months
Percent of subjects who completed the sequence of training sessions and retention sessions. Range: 0-100. Higher percentage indicates more completion
次要结局
- The change in vertical ground reaction force before and after intervention(Up to 2 months)
- The change in the Knee Injury and Osteoarthritis Outcome Quality of Life subscale score(Up to 2 months)
- The change in peak internal knee extension moment(Up to 2 months)
- The change in T1ρ MRI relaxation times in the medial femoral condyle before and after intervention(Up to 2 months)
- The change in the Anterior Cruciate Ligament Return to Sport After Injury Scale score(Up to 2 months)
- The change in T1ρ MRI relaxation times before and after intervention(Up to 2 months)
- The change in T1ρ MRI relaxation times in the lateral femoral condyle before and after intervention(Up to 2 months)
- The change in T1ρ MRI relaxation times in the medial tibial condyle before and after intervention(Up to 2 months)
- The change in T1ρ MRI relaxation times in the lateral tibial condyle before and after intervention(Up to 2 months)
- The change in the International Knee Documentation Committee Subjective Knee Evaluation form score(Up to 2 months)
- The change in the Tegner Activity Scale score(Up to 2 months)
- The change in peak vGRF(Up to 2 months)
- The change in the Visual, Aural, Reading/Writing, and Kinesthetic Questionnaire score(Up to 2 months)
- The change in peak knee flexion excursion(Up to 2 months)
- The change in joint tissues metabolism by assessing biomarker chemokine (monocyte chemoattractant protein-1 (MCP-1)).(Up to 2 months)
- The change in joint tissues metabolism by assessing degenerative matrix metalloproteinase-3 (MMP-3) enzyme.(Up to 2 months)
- The change in joint tissues metabolism by assessing marker of cartilage turnover (cartilage oligomeric matrix protein (COMP)).(Up to 2 months)