Sports Rehabilitation Therapy for Knee Joint Sports Injuries: A Case Study of Anterior Cruciate Ligament Injury and Patellar Chondromalacia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 160
- 试验地点
- 4
- 主要终点
- International Knee Documentation Committee Subjective Knee Form Score
研究概览
简要总结
The primary objective of this clinical trial is to verify the superiority of a digital diagnosis and treatment system for the conservative management of knee sports injuries-based on wearable sensors, machine vision, and large language models-over conventional off-site rehabilitation in terms of functional outcomes. The secondary objectives include assessing safety and adverse events, compliance and feasibility, algorithm evaluation accuracy and usability, and generating clinical evidence to support the registration of a Class II medical device. Participants will undergo a six-month intervention comprising knee muscle strengthening exercises, lower limb balance and stability training, and stretching exercises. Follow-up assessments will be conducted every four weeks, recording IKDC and Lysholm subjective knee function scores, VAS pain scores, SF-36 quality of life scores, knee range of motion, and MRI findings.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-50 years.
- •Clinical symptoms, signs, and MRI diagnosis confirming ACL rupture.
- •First-time unilateral ACL rupture.
- •Clinical symptoms, signs, and MRI diagnosis confirm patellofemoral cartilage injury.
- •Presence of at least one of the following manifestations:
- •Initially, unilateral knee presents with dull pain, soreness, or a sense of weakness, followed by increased knee pain predominantly located behind the patella. Pain worsens after exertion, with difficulty climbing up or down stairs, and alleviates or disappears after rest. The pain VAS score is ≤6 points.
- •Positive unilateral knee patellar grind test and/or positive patellar compression test and/or positive squat test.
- •Ability to understand and sign the informed consent form, voluntarily participate in the study, and cooperate with follow-up.
排除标准
- •Body Mass Index (BMI) less than 18.5 or greater than 35 kg/m²;
- •Age greater than 50 years or less than 18 years;
- •History of knee surgery or presence of other conditions, such as tumors, rheumatoid arthritis, tuberculosis, etc.;
- •Severe cardiopulmonary dysfunction, neurological disorders, or other conditions unsuitable for exercise rehabilitation;
- •Pregnant or lactating women;
- •Individuals unwilling to undergo this treatment method.
研究组 & 干预措施
Experimental Group
Off-site rehabilitation management is conducted based on an integrated system of "wearable sensors + machine vision + large language models." This includes real-time/periodic collection of exercise data, posture and movement monitoring via machine vision, and personalized rehabilitation guidance provided through a large language model platform.
干预措施: Muscle Strength Training (Other)
Experimental Group
Off-site rehabilitation management is conducted based on an integrated system of "wearable sensors + machine vision + large language models." This includes real-time/periodic collection of exercise data, posture and movement monitoring via machine vision, and personalized rehabilitation guidance provided through a large language model platform.
干预措施: Lower limb balance and stability exercises (Other)
Experimental Group
Off-site rehabilitation management is conducted based on an integrated system of "wearable sensors + machine vision + large language models." This includes real-time/periodic collection of exercise data, posture and movement monitoring via machine vision, and personalized rehabilitation guidance provided through a large language model platform.
干预措施: Stretching and Relaxation (Other)
Control group
Rehabilitation guidance is provided using the traditional outpatient follow-up model, where patients regularly visit the clinic for rehabilitation assessments and treatment recommendations under a conventional rehabilitation prescription.
干预措施: Muscle Strength Training (Other)
Control group
Rehabilitation guidance is provided using the traditional outpatient follow-up model, where patients regularly visit the clinic for rehabilitation assessments and treatment recommendations under a conventional rehabilitation prescription.
干预措施: Lower limb balance and stability exercises (Other)
Control group
Rehabilitation guidance is provided using the traditional outpatient follow-up model, where patients regularly visit the clinic for rehabilitation assessments and treatment recommendations under a conventional rehabilitation prescription.
干预措施: Stretching and Relaxation (Other)
结局指标
主要结局
International Knee Documentation Committee Subjective Knee Form Score
时间窗: week0、week4、week8、week12、week24
The scoring dimensions (18 items in total) include: Symptoms (7 items): pain frequency, pain at rest, pain during activity, swelling, joint locking, sensation of joint instability. Activities of daily living (9 items): walking, ascending and descending stairs, kneeling, squatting, rising from a seated position, running, jumping, turning, and sudden stopping ability. Sports participation (2 items): comparison of current sports activity level with pre-injury level. Scoring rules: each item corresponds to a score (0-4 points or 0-10 points), and the total score is standardized to a 0-100 scale. A higher score indicates better function (100 points = no limitations whatsoever).
Lysholm Knee Scoring Scale
时间窗: week0、week4、week8、week12、week24
Scoring Dimensions (8 items in total): Limping (5 points) Need for support (5 points) Joint locking (15 points) Joint instability (25 points) Pain (25 points) Swelling (10 points) Ascending and descending stairs (10 points) Squatting (5 points) Scoring Rules: The total score ranges from 0 to 100 points, with the score corresponding to functional levels as follows: ≥95 points: Excellent 84-94 points: Good 65-83 points: Fair \<65 points: Poor
次要结局
- Visual Analogue Scale(week0、week4、week8、week12、week24)
- 36-Item Short Form Health Survey(week0、week4、week8、week12、week24)
- Knee Range of Motion(week0、week4、week8、week12、week24)
- Knee MRI(week0、week4、week12、week24)