Conventional rehabilitation with or without digital therapy to restore quadriceps activation after ACL reconstruction
Comparison of Arthrogenic Muscle Inhibition (AMI) After ACL Reconstruction in Patients With Conventional Rehabilitation or Conventional Rehabilitation Combined With Digital Therapy
This trial tests whether adding a smartphone-based digital therapy to standard physiotherapy helps adults recovering from ACL reconstruction overcome quadriceps muscle inhibition.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 448 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | GCS Ramsay Santé pour l'Enseignement et la Recherche Academic / other |
| Locations | 1 site (Lyon, France) |
| Trial ID | NCT07030764 on ClinicalTrials.gov |
What this trial studies
Adults scheduled for primary ACL reconstruction at a single center in Lyon are enrolled and assigned to receive either conventional physiotherapy alone or conventional physiotherapy combined with a digital therapy platform (DOCT'UP) delivered via smartphone. The program targets arthrogenic muscle inhibition (AMI) to improve voluntary quadriceps activation, adherence to exercises, and functional recovery. Outcomes will include measures of muscle activation, strength, functional performance, and adherence over the rehabilitation period. Participation requires French language ability, smartphone and internet access, and no prior ipsi- or contralateral knee surgery or multi-ligament injury.
Who should consider this trial
Good fit: Adults (≥18) scheduled for primary ACL reconstruction who speak French, have a smartphone and internet access, and can perform supervised physical exercise are ideal candidates.
Not a fit: Patients with residual AMI, prior knee surgery, multi-ligament injuries, contraindications to exercise, cognitive problems, no internet/smartphone access, pregnancy, or legal protection status are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, adding digital therapy could help patients regain quadriceps strength faster and shorten rehabilitation after ACL reconstruction.
How similar studies have performed: Digital rehabilitation programs have improved adherence and functional outcomes in other orthopedic settings, but direct evidence specifically targeting AMI after ACL reconstruction is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Lyon, France
- Hôpital Privé Jean Mermoz — Lyon, France, France (Recruiting)
Study contacts
- Study coordinator: Benjamin FREYCHET, MD
- Email: benjamin.freychet@gmail.com
- Phone: +33437530708
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.