Medical benefits of telerehabilitation with Orthelligent HOME® after anterior cruciate ligament (ACL) reconstruction: study protocol for a randomised controlled trial – the ORSOME-II study

Background: Digital technologies are increasingly being integrated into home-based telerehabilitation programmes for orthopaedic indications. Generally, patient-individualised and rehabilitation progress-specific adaptations can support early rehabilitation after knee surgery for anterior cruciate ligament reconstruction (ACL-R). The designed study will evaluate the medical benefit of a digital telerehabilitation system in addition to standard physiotherapy during the early rehabilitation phase. Methods: In a prospective, randomised controlled, single-blinded multicenter trial, 204 patients with a planned ACL-R (male/female, age 14–65 years) will be recruited and randomly assigned to either a control group (physiotherapy, standard of care) or the intervention group to use the telerehabilitation system Orthelligent HOME® in addition to standard of care after surgery. As prespecified objectifiable primary outcome, knee function and stability will be assessed 9 weeks postoperatively by single-leg vertical jump. Jump height and jump quality will be measured using the My Jump app and an evaluation matrix to quantify defined pre stages of the vertical jump performance. Subjective knee function (IKDC-SKF) and knee-related quality of life (KOOS) will be assessed as secondary outcomes. Additionally, return-to-sports (ACL-RSI), return-to-work, and non-sport-based knee-related everyday function (LERAS-13) as well as use of therapeutic appliances and aids will be quantified. All patients will be followed up for 52 weeks. Discussion: This protocol seeks to determine the medical benefit of a digital rehabilitation tool in enhancing ACL recovery outcomes, potentially addressing the rehabilitation gap often experienced by patients following supervised physical therapy. It aims to provide information on the potential of using digital rehabilitation devices as a supplement to standard physiotherapy for early rehabilitation after ACL-R. Trial registration: German Clinical Trials Register (DRKS): DRKS00031465 (registration date: 10.07.2023, prospectively registered). © The Author(s) 2025.