Comparison of Arthrogenic Muscle Inhibition (AMI) After ACL Reconstruction in Patients With Conventional Rehabilitation or Conventional Rehabilitation Combined With Digital Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 448
- 试验地点
- 2
- 主要终点
- AMI rate
研究概览
简要总结
Traumatic injury to the knee joint, such as rupture of the anterior cruciate ligament (ACL), can compromise the voluntary activation capacity of the quadriceps despite the anatomical integrity of the nerve and muscle structures responsible for contraction. This phenomenon is commonly known as 'arthrogenic muscle inhibition' (AMI).
AMI is a major limiting factor in recovery and rehabilitation after ACL rupture, and a potential cause of functional disability if left undiagnosed and untreated.
Traditional rehabilitation protocols for ACL reconstruction do not adequately address the underlying neuromuscular deficits caused by AMI, leading to sub-optimal recovery and prolonged rehabilitation. Furthermore, patient adherence to these protocols, outside of supervised settings, is variable and often poor, which can further delay recovery
Recent advances in digital health technologies offer new ways of improving rehabilitation outcomes. Numerous studies highlight the effectiveness of digital therapies in the form of mobile applications in improving patient engagement and compliance with rehabilitation protocols. In addition, evidence suggests that the integration of these technologies enables faster recovery of muscle function, reduces pain levels, may reduce complications such as Cyclops syndrome and improves overall patient satisfaction with rehabilitation.
Healing has developed a digital therapy called DOCT'UP® which, in addition to physiotherapy sessions, offers support programmes for patients following ACL reconstruction. These programmes include self-education exercises to be carried out at home, some of which specifically target the AMI phenomenon. DOCT'UP® digital therapy has already been used in rehabilitation after ACL reconstruction, with results at 3 weeks on quadriceps activation and post-operative pain, as well as at 1 year on Cyclops syndrome.
Given the limitations of current rehabilitation practices in the context of AMI and the potential of the DOCT'UP® application, there is a clear need to scientifically assess whether the DOCT'UP® application can effectively improve the results of rehabilitation on AMI after ACL reconstruction. This is why the sponsor wishes to set up this Clinical Investigation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient, male or female, aged ≥ 18 years
- •Patient with a scheduled primary ACL reconstruction
- •Patient with a smartphone and able to use a mobile application on a smartphone
- •Patient affiliated to or benefiting from a social security scheme
- •French-speaking patient who has signed an informed consent form
排除标准
- •Patients with residual AMI
- •Patient with previous ipsi or contralateral knee surgery
- •Patient with a multi-ligament injury
- •Patient with contraindications to physical exercise: severe cardiovascular disease or uncontrolled metabolic disease
- •Patients with cognitive problems
- •Patient without internet access
- •Patient taking part in another study
- •Pregnant or breast-feeding women
- •Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
结局指标
主要结局
AMI rate
时间窗: 3 weeks
The rate of patients with an AMI will be defined as a percentage of patients with AMI according to the Sonnery-Cottet classification (Sonnery-Cottet et al, 2022).
Physiotherapy adherence
时间窗: 6 months
Physiotherapy adherence will include number of physiotherapy sessions per patient
次要结局
未报告次要终点