Dynamic Gait-Synchronous Neuromuscular Electrical Stimulation Following Anterior Cruciate Ligament Reconstruction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in gait post-operatively assessed by the KneeStimTM Device
研究概览
简要总结
The goal of this clinical trial is to examine the effects of 12 weeks of post-operative use of a novel wearable electrical stimulation knee sleeve device (KneeStim) on post-operative biomechanical function (gait). Participants will be United States Military Academy cadets aged 17-27 years. The main questions it aims to answer are:
- Examine the effects of KneeStim wear on cadets' post-operative gait
- Examine changes in site-specific skeletal muscle mass
- Examine the changes in patient-reported outcomes
- Assess time to return to full duty
- Compare Bioelectrical Impedance Analysis (BIA) measurements to Magnetic Resonance Imaging (MRI) measurements (total thigh volume)
- Determine the concurrent criterion validity of the KneeStim device compared to gold- standard metrics (3D Motion Capture)
Participants will undergo body composition analysis, MRI, strength testing, standard of care rehabilitation, gait analysis, and complete surveys. Participants will wear the KneeStim during their standard of care rehabilitation visits for the first 5 weeks post-operative, and throughout daily tasks from 6-12 weeks.
Researchers will compare a control group (standard of care + KneeStim controlled low intensity) to an experimental group (standard of care + KneeStim flexible intensity) to assess the aims previously mentioned..
详细描述
Anterior cruciate ligament (ACL) tears have a recovery time of nearly 6-12 months with operative treatment. While most service members return to full duty after ACL reconstruction, it is delayed by quadriceps activation, muscle weakness, and abnormal gait patterns. Neuromuscular electric stimulation devices are already being used in physical therapy to complement gains in muscle strength and size. The innovation of KneeStim, is that it can be used to stimulate knee muscles while the individual is engaging in their daily activities. This study looks at the effects of 12 weeks of post-operative use of the KneeStim on biomechanical function (gait) in United States Military Academy Cadets aged 17-27 years of age. The investigators hypothesize that using the KneeStim will accelerate normalization of the biomechanical function parameters of gait and thus return to full duty.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 17 Years 至 27 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •United States Military Academy cadet between ages of 17-27 years
- •Undergoing a Primary ACL Reconstruction, or Revision ACL Reconstruction
排除标准
- •Concomitant or prior high tibial osteotomy (HTO)
- •Concomitant or prior cartilage restoration procedure
- •Concomitant ligamentous reconstruction (lateral collateral ligament; posterior cruciate ligament; medial collateral ligament)
- •Contraindications to using the KneeStim device
- •- Use of pacemaker, defibrillators, or other implanted electronic devices, as this may cause electric shock, burns, electrical interference, or death Unstable angina or decompensated heart failure Epilepsy or history of seizure disorder Pregnancy or planning to become pregnant (Self reported) Critical ischemia of lower limbs Moderate to severe dementia Altered sensation at the knee such that the user cannot feel a pinprick Undiagnosed pain syndromes
- •Any meniscus tear precluding weight bearing for 6 weeks.
研究组 & 干预措施
Standard of Care + KneeStim controlled low intensity
Low intensity range
干预措施: KneeStim (Device)
Standard of Care + KneeStim flexible intensity
Flexible to high intensity range
干预措施: KneeStim (Device)
结局指标
主要结局
Change in gait post-operatively assessed by the KneeStimTM Device
时间窗: 6 weeks;3, 6, 9, 12 months post-operative
Effects of a novel wearable electrical stimulation knee sleeve device (KneeStim) on post-operative biomechanical function (femur sagittal angle, tibial sagittal angle, femur coronal angle, tibial coronal angle, femur and tibia coronal velocity)
次要结局
- change in gait post-operatively assessed by force plate instrumented treadmill(3, 6, 9, 12 months post-operative)
- change in muscle volume assessed by MRI(pre-operative, 3, 6, 9, 12 months post-operative)
- ACL graft healing assessed by MRI(pre-operative, 3, 6, 9, 12 months post-operative)
- Change in isometric muscle strength assessed by CSMi HUMAC NORM(3, 6, 9, 12 months post-operative)
- Change in skeletal muscle mass assessed by bioelectrical impedance analysis (SECA BIA)(pre-operative, 4, 8 weeks; 3, 6, 9, 12 months post-operative)
- Change in lean body mass assessed by bioelectrical impedance analysis (SECA BIA)(pre-operative, 4, 8 weeks; 3, 6, 9, 12 months post-operative)
- Change in fat mass assessed by bioelectrical impedance analysis (SECA BIA)(pre-operative, 4, 8 weeks; 3, 6, 9, 12 months post-operative)
- change in gait post-operatively assessed by 3D Motion capture(3, 6, 9, 12 months post-operative)
- Change in knee pain and function assessed by the Knee Injury and Osteoarthritis Score (KOOS)(pre-operative, 3, 6, 9, 12 months post-operative)
- Change in knee pain and function assessed by the International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC)(pre-operative, 3, 6, 9, 12 months post-operative)
- Change in knee pain assessed by the Patient-Reported Outcome Measure Information System (PROMIS-29)(pre-operative, 3, 6, 9, 12 months post-operative)
- Change in knee function assessed with the Single Assessment Numeric Evaluation Method (SANE)(pre-operative, 3, 6, 9, 12 months post-operative)
- Change in knee function assessed by the Marx Activity Rating Scale (MARS)(pre-operative, 3, 6, 9, 12 months post-operative)
- Impact of ACL surgery on overall quality of life assessed by the Anterior Cruciate Ligament-Quality of Life (ACL-QOL)(pre-operative, 3, 6, 9, 12 months post-operative)
- Change of running gait function from the patients' perspective assessed by the University of Wisconsin Running Injury and Recovery Index (UWRI)(pre-operative, 3, 6, 9, 12 months post-operative)
- Change of knee pain from the patients' perspective assessed by the Visual Analog Scale (VAS)(Weekly from 1-week post-operative until 3 months; monthly from 4-12 months)
- Time to return to full duty(12 months post-operative)
- Difference between the Tindeq Progessor and CSMi HUMAC NORM in measuring knee extensor rate of torque development.(At either month 3, 6, 9, or 12, Tindeq testing will occur 24-72 hours after the bilateral strength assessment using the CSMi HUMAC NORM.)
- change in gait post-operatively assessed by 3D Motion capture(3, 6, 9, 12 months post-operative)
- change in gait post-operatively assessed by force plate instrumented treadmill(3, 6, 9, 12 months post-operative)
- change in muscle volume assessed by MRI(pre-operative, 3, 6, 9, 12 months post-operative)
- ACL graft healing assessed by MRI(pre-operative, 3, 6, 9, 12 months post-operative)
- Change in isometric muscle strength assessed by CSMi HUMAC NORM(3, 6, 9, 12 months post-operative)
- Change in skeletal muscle mass assessed by bioelectrical impedance analysis (SECA BIA)(pre-operative, 4, 8 weeks; 3, 6, 9, 12 months post-operative)
- Change in lean body mass assessed by bioelectrical impedance analysis (SECA BIA)(pre-operative, 4, 8 weeks; 3, 6, 9, 12 months post-operative)
- Change in fat mass assessed by bioelectrical impedance analysis (SECA BIA)(pre-operative, 4, 8 weeks; 3, 6, 9, 12 months post-operative)
- Change in knee pain and function assessed by the Knee Injury and Osteoarthritis Score (KOOS)(pre-operative, 3, 6, 9, 12 months post-operative)
- Change in knee pain and function assessed by the International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC)(pre-operative, 3, 6, 9, 12 months post-operative)
- Change in knee pain assessed by the Patient-Reported Outcome Measure Information System (PROMIS-29)(pre-operative, 3, 6, 9, 12 months post-operative)
- Change in knee function assessed by the Marx Activity Rating Scale (MARS)(pre-operative, 3, 6, 9, 12 months post-operative)
- Difference between the Tindeq Progessor and CSMi HUMAC NORM in measuring peak isometric knee extensor torque.(At either month 3, 6, 9, or 12, Tindeq testing will occur 24-72 hours after the bilateral strength assessment using the CSMi HUMAC NORM.)
- Change in knee function assessed with the Single Assessment Numeric Evaluation Method (SANE)(pre-operative, 3, 6, 9, 12 months post-operative)
- Change of running gait function from the patients' perspective assessed by the University of Wisconsin Running Injury and Recovery Index (UWRI)(pre-operative, 3, 6, 9, 12 months post-operative)
- Time to return to full duty(12 months post-operative)
- Impact of ACL surgery on overall quality of life assessed by the Anterior Cruciate Ligament-Quality of Life (ACL-QOL)(pre-operative, 3, 6, 9, 12 months post-operative)
- Change of knee pain from the patients' perspective assessed by the Visual Analog Scale (VAS)(Weekly from 1-week post-operative until 3 months; monthly from 4-12 months)
研究者
Shawn Gee, MD
MD
Keller Army Community Hospital