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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGCS Ramsay Santé pour l'Enseignement et la Recherche

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • DOCT'UP

    Device

    In addition to conventional physiotherapy sessions, DOCT'UP® is a mobile application which offers support programmes for patients following ACL reconstruction. This is digital therapy based on homebased physical exercises to be performed by patient.

  • Physiotherapy

    Behavioral

    Physiotherapy includes sessions performed at physiotherapist office under physiotherapist overview

Treatment groups

448 Participants
are divided into 2 treatment groups
Group A: Conventional rehabilitationOther 1 intervention
Group B: Aaugmented rehabilitationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

AMI rate

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).

Time frame
3 weeks
2

Physiotherapy adherence

Physiotherapy adherence will include number of physiotherapy sessions per patient

Time frame
6 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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