Personalized 12-week digital exercise program to correct knee movement after ACL reconstruction

Personalized Digital Training Intervention to Reduce Inflammation by Correcting Pathological Movement Patterns in Pre-stage Knee Osteoarthritis (OA)

This program will try a 12-week sensor-guided exercise plan for adults 8–12 weeks after ACL reconstruction to correct harmful knee movements and reduce joint inflammation that can lead to early knee osteoarthritis.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 50 Years
• Sex: All
• Sponsor: Charite University, Berlin, Germany (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 2 sites (Berlin and 1 other locations)
• Trial ID: NCT06596824 on ClinicalTrials.gov

What this trial studies

This interventional program delivers a personalized, sensor-based training regimen over 12 weeks aimed at normalizing pathological knee movement patterns after primary ACL reconstruction. Participants complete a baseline assessment between 8 and 12 weeks post-op and then follow digitally guided exercises with real-time feedback from wearable sensors. The intervention targets pre-stage osteoarthritis by reducing abnormal joint loading and markers of inflammation through movement retraining. Eligibility limits include ages 18–50, BMI <30, unilateral primary ACL reconstruction, and no radiographic joint-space narrowing consistent with established OA.

Who should consider this trial

Good fit: Ideal candidates are adults 18–50 who had a primary unilateral ACL reconstruction, can complete baseline testing 8–12 weeks after surgery, and meet BMI and activity-level criteria without signs of established knee OA.

Not a fit: Patients with established radiographic knee OA, BMI ≥30, inflammatory arthropathies, previous surgeries on the study knee, or who cannot attend required assessments are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, the program could lower joint inflammation and delay or prevent early knee osteoarthritis after ACL reconstruction.

How similar studies have performed: Some rehabilitation programs using biofeedback and targeted movement training have improved function after ACL reconstruction, but using wearable sensor-guided personalized training specifically to reduce inflammation and prevent OA is relatively novel and not yet proven.

Eligibility criteria

Inclusion Criteria:

* Signed written informed consent
* Adult subjects between 18 to 50 years old at the time of screening
* Primary ACL reconstruction within a maximum of 6 months after a unilateral ACL injury
* Complete baseline assessment between 8 and 12 weeks after ACL reconstruction

Exclusion Criteria:

* Significant trauma to a weight-bearing joint within 12 months prior to study initiation (excluding the ACL injury)
* Previous surgeries on the study knee (except for the ACL reconstruction)
* Signs of knee OA as defined by the OARSI-Joint Space Narrowing (JSN) Score of two or more (standing AP x-ray)
* Physical activity level: Tegner activity score before injury of 0-2 (very low activity) or 8-10 (very high activity)
* Body mass index ≥ 30 kg/m2;
* Inflammatory arthropathies;
* Immunosuppression due to illness or medication;
* Sepsis or hemostasis disorders;
* Severe uncontrolled inflammatory disease or autoimmune disease (e.g., ulcerative colitis, Crohn's disease, etc.);
* Having malignancy and undergoing treatment including chemotherapy, radiotherapy, or immunotherapy;
* Contraindications for MRI, including pacemakers, defibrillators, metal implants, pregnancy, sensorineural hearing loss above 30 dB, tinnitus and claustrophobia
* Unable to freely give their informed consent (e.g., individuals under legal guardianship).
* Currently enrolled in or has not yet completed a period of at least 5 times as the half-life time of the drug used in the previous trial since ending other investigational device or drug trial(s)
* Patients who are dependent on the sponsor, investigator, or study site;
* Pregnant or breast-feeding women or women of childbearing potential not protected by an effective contraceptive method of birth control (defined as pearl index \< 1);
* Any form of substance abuse, psychiatric disorder, or other condition that, in the opinion of the Investigator, may invalidate communication with the Investigator and/or designated study personnel;
* Patients who are committed to an institution by virtue of an order issued by either the judicial or the administrative authorities;

Where this trial is running

Berlin and 1 other locations

• Charité - Universitätsmedizin Berlin, BeMoveD - Berlin Movement Diagnostics — Berlin, Germany (Recruiting)
• Charité - Universitätsmedizin Berlin — Berlin, Germany (Recruiting)

Study contacts

• Study coordinator: Winkler, Prof. Dr.med.

Conditions Osteoarthritis of the Knee; ACL Reconstruction