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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Charité - Universitätsmedizin Berlin, BeMoveD - Berlin Movement Diagnostics
  Berlin, Germany Recruiting
• Charité - Universitätsmedizin Berlin
  Berlin, Germany Recruiting

Study contacts

• Study coordinator: Winkler, Prof. Dr.med.
• Email: tobias.winkler@charite.de
• Phone: +49 30 450 559084

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.