Effectiveness of Robot-Aided Off-Axis Neuromuscular Training for Knee Osteoarthritis: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 36
- 主要终点
- Peak knee adduction moment
研究概览
简要总结
Although the primary knee motion occurs in flexion/extension, the frontal and transverse (off-axis) knee motions are smaller but crucial for maintaining joint stability and normal knee loading. Altered kinematics and neuromuscular control in off-axis knee motions have been reported in patients with knee osteoarthritis (OA), which are associated with excessive knee loading and the progression of knee OA. However, traditional rehabilitative treatments for people with knee OA and existing exercise equipment often focus on sagittal plane movement. Probably due to the technical limitations, there is a lack of convenient and effective equipment/method to train patients with knee OA in off-axis (frontal and transverse) planes.
The purpose of this study is to use a robot-aided elliptical training device to measure knee neuromechanical properties and to improve neuromuscular control in off-axis knee motions, aiming for joint de-loading and pain reduction for individuals with knee OA.
详细描述
The device used in this study is provided by Rehabtek LLC, which has received U.S. federal grants to develop and commercialize this device.
Eligible knee osteoarthritis (OA) patients will be randomly assigned to three groups: (A) evaluation-based, progressive, neuromuscular training group; (B) traditional regular stepping group.
Participants in both groups will undergo 3 assessments.
Once the participants have consented, the first assessment visit will be scheduled before the training, which includes the neuromechanical and clinical assessments:
- The neuromechanical assessments involve the off-axis knee moments and instability during the free-speed stepping and fast stepping tasks on the elliptical machine to see which off-axis directions (knee valgus, varus, internal rotation, and/or external rotation) or combination of directions show excessive moments. Off-axis instability, muscle strength, range of motion, stiffness, proprioception acuity, and knee moments during stepping will also be evaluated.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 45 - 85 years.
- •Meets the ACR classification criteria for knee OA (clinical + radiographic criteria); Kellgren-Lawrence grade I-III.
- •Persistent knee pain ≥ 3 months.
- •Able to independently complete elliptical training (6 minutes without interruption).
排除标准
- •Other inflammatory joint diseases (e.g., rheumatoid arthritis).
- •Knee trauma, surgery, or intra-articular injections within the past year.
- •History of knee or hip replacement.
- •Cardiovascular disease or uncontrolled hypertension contradict to exercises.
- •Cognitive impairment (Montreal cognitive assessment < 22).
- •Currently participating in another interventional study for the lower limb.
- •Neurological impairment (e.g., stroke, Parkinson's disease, radicular pain).
研究组 & 干预措施
evaluation-based, progressive, off-axis neuromuscular training group
干预措施: Robot-Aided Off-Axis Neuromuscular Training (Device)
traditional elliptical regular stepping group
干预措施: Traditional elliptical regular stepping (Device)
结局指标
主要结局
Peak knee adduction moment
时间窗: Baseline, immediately after the 5-week training, and follow-up evaluation 8-week post-training
Knee pain
时间窗: Baseline, immediately after the 5-week training, and follow-up evaluation 8-week post-training
Questionnaires, including the Knee Injury and Osteoarthritis Outcome Score (KOOS)
次要结局
- Functional ability(Baseline, immediately after the 5-week training, and follow-up evaluation 8-week post-training)
- Heath-related quality of life(Baseline, immediately after the 5-week training, and follow-up evaluation 8-week post-training)
- Knee proprioception acuity/pain in off-axis directions(Baseline, immediately after the 5-week training, and follow-up evaluation 8-week post-training)
- Knee range of motions/stiffness/laxity in off-axis directions(Baseline, immediately after the 5-week training, and follow-up evaluation 8-week post-training)
- Functional ability(Baseline, immediately after the 5-week training, and follow-up evaluation 8-week post-training)
- Heath-related quality of life(Baseline, immediately after the 5-week training, and follow-up evaluation 8-week post-training)
研究者
Li-Qun Zhang
Professor
University of Maryland, Baltimore