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
- 1
- 主要终点
- Reasons for refusal to enroll
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.
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
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
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.
次要结局
- 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 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)
- 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 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)