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NCT Number: NCT07030764

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Privé Jean Mermoz

Lyon, France, 69008

Location status: Recruiting

Location contact

Benjamin FREYCHET, MD

CONTACT

[email protected]

+33437530708

Benjamin FREYCHET, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. AMI rate

    Time frame: 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).

  2. Physiotherapy adherence

    Time frame: 6 months

    Physiotherapy adherence will include number of physiotherapy sessions per patient

Study contacts

Contact information is provided by the study sponsor or research team.

Benjamin FREYCHET, MD

CONTACT

[email protected]

+33437530708

Sponsors and collaborators

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Other

Registry information

Acronym: AMITHENUM

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 22, 2025
Registry last updated
Sep 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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