Actively Recruiting
Personalized Digital Training Intervention to Reduce Inflammation by Correcting Pathological Movement Patterns in Pre-stage Knee Osteoarthritis (OA)
Led by Charite University, Berlin, Germany · Updated on 2026-03-02
60
Participants Needed
2
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Osteoarthritis (OA) is a joint condition causing pain and stiffness, often resulting from injuries such as torn ligaments. Even after surgery like anterior cruciate ligament (ACL) reconstruction, these injuries can lead to long-term joint problems and OA development. Current treatments do not fully prevent OA, so this research is evaluating a new 12-week exercise program using a special sensor-based system to improve knee movement. The aim is to reduce joint inflammation and help prevent OA in patients after knee surgery. Participants are randomly assigned to one of two groups. One group receives the standard physiotherapy program, while the treatment group gets additional personalized exercise training using sensor technology that provides a 3D avatar and an app. This digital training targets correcting harmful knee movements and loading patterns that worsen joint inflammation and contribute to OA. The intervention lasts 12 weeks alongside regular physiotherapy. During the study, participants will undergo assessments at different time points including baseline, 6 months, and 36 months after starting. These evaluations include imaging of knee cartilage thickness, volume, composition, meniscus position, and inflammation markers using MRI. The main outcome is measured at 6 months to assess the program’s effect on knee health. Researchers will also monitor safety and participants’ adherence throughout the study period, which continues until the end of 2027.
CONDITIONS
Brief Title
Personalized Digital Training Intervention to Reduce Inflammation by Correcting Pathological Movement Patterns in Pre-stage Knee Osteoarthritis After Anterior Cruciate Ligament Reconstruction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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 830 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 6 months
Participants receive a personalized digital training intervention using sensor-based technology and an app to correct pathological knee movement patterns. This is in addition to standard-of-care physiotherapy to reduce inflammation and prevent knee osteoarthritis progression.
Regular visits as part of physiotherapy and training intervention
Duration - Up to 36 months
Participants undergo follow-up assessments to evaluate cartilage, meniscus, and synovitis status using MRI and other measures at baseline, 6, and 36 months.
3 visits (Baseline, 6 months, and 36 months follow-up)
Trial Site Locations
Total: 2 locations
1
Charité - Universitätsmedizin Berlin, BeMoveD - Berlin Movement Diagnostics
Berlin, Germany, 10117
Actively Recruiting
2
Charité - Universitätsmedizin Berlin
Berlin, Germany, 10117
Actively Recruiting
Research Team
W
Winkler, Prof. Dr.med.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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