Hôpital Privé Jean Mermoz
Lyon, France, 69008
Location status: Recruiting
Location contact
Benjamin FREYCHET, MD
CONTACT
Benjamin FREYCHET, MD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07030764
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Lyon, France, 69008
Location status: Recruiting
Benjamin FREYCHET, MD
CONTACT
Benjamin FREYCHET, MD
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 includes sessions performed at physiotherapist office under physiotherapist overview
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).
Time frame: 6 months
Physiotherapy adherence will include number of physiotherapy sessions per patient
Contact information is provided by the study sponsor or research team.
GCS Ramsay Santé pour l'Enseignement et la Recherche
Other
Acronym: AMITHENUM
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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