Personalized Digital Training Intervention to Reduce Inflammation by Correcting Pathological Movement Patterns in Pre-stage Knee Osteoarthritis After Anterior Cruciate Ligament Reconstruction

NCT ID: NCT06596824

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2027-12-31

Brief Summary

Osteoarthritis (OA) is a condition that causes pain and stiffness in the joints, often due to injuries like torn ligaments. Even after surgery, these injuries can lead to long-term joint problems. Current treatments don't fully prevent OA from developing. This study is testing a new 12-week exercise program designed to improve how the knee moves, using a special sensor-based system. The goal is to reduce joint inflammation and prevent the development of OA in patients who have had knee surgery.

Conditions

Osteoarthritis (OA) of the Knee; ACL Reconstruction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

The treatment group

In addition to the standard-of-care physiotherapy program, the treatment group will additionally receive a training intervention utilizing sensor-based technology that provides 3D avatar training, supported by an accompanying app, to deliver personalized exercise regimens. This intervention aims to correct the pathological knee movement and loading patterns that exacerbate joint inflammation and contribute to the development of knee OA.

Group Type: EXPERIMENTAL

Training intervention

Intervention Type: BEHAVIORAL

Personalized digital training intervention aims to correct pathological knee movement and loading patterns and reduce inflammation in pre-stage knee osteoarthritis.

the control group

Standard-of-care physiotherapy program

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Training intervention

Personalized digital training intervention aims to correct pathological knee movement and loading patterns and reduce inflammation in pre-stage knee osteoarthritis.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Signed written informed consent
• Underwent anterior cruciate ligament reconstruction (ACLR) due to an acute knee injury in the past 12 months
• ACLR patients with aberrant gait profiles who exhibit all three aberrant characteristics (knee flexion angle, knee flexion moment, and knee adduction moment)

Exclusion Criteria

• Previous trauma or surgery (other than ACLR) to any weight-bearing joint,
• Signs of knee OA as defined by the OARSI-Joint Space Narrowing (JSN) Score of two or more (standing AP x-ray)
• 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;
• 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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Tobias Winkler

Prof. Dr.med.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Charité - Universitätsmedizin Berlin

Berlin, , Germany

Countries

Germany

Central Contacts

Winkler, Prof. Dr.med.

Role: CONTACT

tobias.winkler@charite.de

+49 30 450 559084

Facility Contacts

Winkler, Prof.Dr.med.

Role: primary

tobias.winkler@charite.de

+49 30 450 559084

Other Identifiers

101095635

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

PROTO-WP4

Identifier Type: -

Identifier Source: org_study_id