Personalized Digital Training Intervention to Reduce Inflammation by Correcting Pathological Movement Patterns in Pre-stage Knee Osteoarthritis (OA)
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
- Primary Endpoint
研究概览
简要总结
Osteoarthritis (OA) is a condition that causes pain and stiffness in the joints, often due to injuries like torn ligaments. Even after surgery, these injuries can lead to long-term joint problems. Current treatments don't fully prevent OA from developing. This study is testing a new 12-week exercise program designed to improve how the knee moves, using a special sensor-based system. The goal is to reduce joint inflammation and prevent the development of OA in patients who have had knee surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •Signed written informed consent
- •Adult subjects between 18 to 50 years old at the time of screening
- •Primary ACL reconstruction within a maximum of 6 months after a unilateral ACL injury
- •Complete baseline assessment between 8 and 12 weeks after ACL reconstruction
排除标准
- •Significant trauma to a weight-bearing joint within 12 months prior to study initiation (excluding the ACL injury)
- •Previous surgeries on the study knee (except for the ACL reconstruction)
- •Signs of knee OA as defined by the OARSI-Joint Space Narrowing (JSN) Score of two or more (standing AP x-ray)
- •Physical activity level: Tegner activity score before injury of 0-2 (very low activity) or 8-10 (very high activity)
- •Body mass index ≥ 30 kg/m2;
- •Inflammatory arthropathies;
- •Immunosuppression due to illness or medication;
- •Sepsis or hemostasis disorders;
- •Severe uncontrolled inflammatory disease or autoimmune disease (e.g., ulcerative colitis, Crohn's disease, etc.);
- •Having malignancy and undergoing treatment including chemotherapy, radiotherapy, or immunotherapy;
- •Contraindications for MRI, including pacemakers, defibrillators, metal implants, pregnancy, sensorineural hearing loss above 30 dB, tinnitus and claustrophobia
- •Unable to freely give their informed consent (e.g., individuals under legal guardianship).
- •Currently enrolled in or has not yet completed a period of at least 5 times as the half-life time of the drug used in the previous trial since ending other investigational device or drug trial(s)
- •Patients who are dependent on the sponsor, investigator, or study site;
- •Pregnant or breast-feeding women or women of childbearing potential not protected by an effective contraceptive method of birth control (defined as pearl index < 1);
- •Any form of substance abuse, psychiatric disorder, or other condition that, in the opinion of the Investigator, may invalidate communication with the Investigator and/or designated study personnel;
- •Patients who are committed to an institution by virtue of an order issued by either the judicial or the administrative authorities;
研究组 & 干预措施
The treatment group
In addition to the standard-of-care physiotherapy program, the treatment group will additionally receive a training intervention utilizing sensor-based technology that provides 3D avatar training, supported by an accompanying app, to deliver personalized exercise regimens. This intervention aims to correct the pathological knee movement and loading patterns that exacerbate joint inflammation and contribute to the development of knee OA.
干预措施: Training intervention (Behavioral)
the control group
Standard-of-care physiotherapy program
结局指标
主要结局
Primary Endpoint
时间窗: at 6-month follow-up visit
Restoration of normal knee angle and moment patterns during walking at 6-month follow-up (compared to normative data), as determined by a machine learning-derived gait index.
次要结局
- Secondary Endpoint: Cartilage Thickness(Baseline, 6, and 36 months follow-up visits)
- Secondary Endpoint: Cartilage Volume(Baseline, 6, and 36 months follow-up visits)
- Secondary Endpoint: Cartilage Composition(Baseline, 6, and 36 months follow-up visits)
- Secondary Endpoint: Meniscus Position(Baseline, 6, and 36 months follow-up visits)
- Secondary Endpoint: Hoffa Synovitis(Baseline, 6, and 36 months follow-up visits)
- Secondary Endpoint: Effusion Synovitis(Baseline, 6, and 36 months follow-up visits)
- Secondary Endpoint: Magnetic Resonance Imaging Osteoarthritis Knee Score (MOAKS)(Baseline, 6, and 36 months follow-up visits)
研究者
Tobias Winkler
Prof. Dr.med.
Charite University, Berlin, Germany