Effect and Evaluation of Long-term Isokinetic Training of Knee Joint Under the Influence of Stiffness
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Cross-sectional area of the quadriceps
研究概览
简要总结
The goal of this clinical trial is to assess the effectiveness of isokinetic rehabilitation training under optimal stiffness in patients undergoing knee joint rehabilitation. The main questions it aims to answer are:
- Does isokinetic training under optimal stiffness lead to greater force exertion compared to traditional bodyweight training?
- What are the long-term (6-week) effects of isokinetic training under optimal stiffness on joint flexibility and muscle strength? Researchers will compare the effects of isokinetic training under optimal stiffness to traditional bodyweight training to see if isokinetic training produces superior improvements in muscle strength, flexibility, and overall functional recovery.
Participants will:
- Perform regular training sessions using a portable knee joint isokinetic trainer, customized to their optimal stiffness for maximum force exertion.
- Engage in a 6-week rehabilitation program, with assessments at the beginning, and end of the study to evaluate changes in muscle strength, and functional recovery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 20-60 years.
- •Patients with unilateral anterior cruciate ligament (ACL) rupture (with or without meniscus injury), posterior cruciate ligament (PCL) rupture, meniscal tear (M), and patellar dislocation (PD).
- •4. Postoperative period of 3-6 months.
- •No restriction in knee extension or flexion movements.
排除标准
- •Patients with major diseases or conditions such as coronary heart disease, myocardial infarction, heart failure, cerebral infarction, cerebral hemorrhage, or malignant tumors.
- •Pregnant or breastfeeding women and other special populations.
- •Patients who refuse to sign the informed consent form or are unable to complete the entire study process.
- •Patients currently infected with human immunodeficiency virus (HIV), or with a history of infectious hepatitis B or C.
- •Patients with concurrent medical issues, including but not limited to: (1) Uncontrolled hypertension (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥95 mmHg), congestive heart failure (New York Heart Association functional classification of stage III or IV). (2) Patients with mental incapacity or an inability to comprehend the study requirements.
研究组 & 干预措施
None-robot-assisted Rehabilitation
The control group will consist of 6 patients who meet the inclusion criteria and will undergo traditional isotonic and isometric rehabilitation
干预措施: traditional rehabilitation (Behavioral)
Robot-assisted Rehabilitation
In this clinical trial, 6 patients who meet the inclusion criteria will be enrolled in the experimental group to undergo rehabilitation using a portable isokinetic device.
干预措施: With robot assistance (Device)
结局指标
主要结局
Cross-sectional area of the quadriceps
时间窗: Before 1st practice, and after 12th practice (6 weeks * 2 practices/week = 12 practices)
Using MRI，Up to 6 weeks
Cross-sectional area of the hamstrings
时间窗: Before 1st practice, and after 12th practice (6 weeks * 2 practices/week = 12 practices)
using MRI， Up to 6 weeks
Peak flexion and extension knee torque
时间窗: During each practice (6 weeks * 2 practices/week = 12 practices).
Using an integrated torque sensor
Average flexion and extension knee torque
时间窗: During each practice (6 weeks * 2 practices/week = 12 practices).
Flexion and extension knee work
时间窗: In each ptractice (6 weeks * 2 practices /week = 12 practices).
Work=Torque\*Speed
次要结局
- Thigh circumference(In each ptractice (6 weeks * 2 practices /week = 12 practices).)
- Knee joint pain score (VAS score)(Before 1st practice, and after 12th practice (6 weeks * 2 practices/week = 12 practices))
- Surface electromyography signals of quadricep and hamstrings(During optimal stiffness measurements)
研究者
Yuan Fuzhen
Principle Investigator
Peking University Third Hospital