Comparison of Arthrogenic Muscle Inhibition (AMI) After ACL Reconstruction in Patients With Conventional Rehabilitation or Conventional Rehabilitation Combined With Digital Therapy (AMITHENUM)

GCS Ramsay Santé pour l'Enseignement et la Recherche

Status: Enrolling

Conditions: ACL - Anterior Cruciate Ligament Rupture

Treatments: Behavioral: Physiotherapy; Device: DOCT'UP

Study type: Interventional

Funder types: Other

Identifiers

NCT07030764

2025-A00730-49

Details and patient eligibility

About

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.

Enrollment: 448 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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448 participants in 2 patient groups

Conventional rehabilitation

Other group

Description:

Conventional rehabilitation includes 40 physiotherapy sessions

Treatment:

Behavioral: Physiotherapy

Aaugmented rehabilitation

Experimental group

Description:

Augmented rehabilitation combines conventional rehabilitation (40 physiotherapy sessions) with the use of DOCT'UP® digital therapy.

Treatment:

Device: DOCT'UP