The PROTECT-study (PROsthesis TElerehab Care Trial), home-based telerehabilitation in post-operative care after shoulder arthroplasty compared to usual care: study protocol for a randomized clinical trial

Abstract

Total shoulder arthroplasty (TSA) has become a commonly used procedure for patients with degenerative shoulder complaints such as severe osteoarthritis, cuff tear arthropathy and for revision surgery. After surgery, patients are generally referred to a physical therapist for rehabilitation. In addition, the general principles of rehabilitation and the advice of the surgeon should be considered when tailoring the rehabilitation to meet the specific needs of the patient. Generally, the goals of rehabilitation are to increase the active range of motion, strengthen the shoulder and scapular muscles, and improve endurance. The ultimate goal is to enhance patients’ daily functioning (such as washing, dressing, housework, leisure and work). Recent experience, specifically and even more during the COVID-19 pandemic, demonstrated the need for telerehabilitation as an alternative or as a supplement to hands-on physical therapy. Telerehabilitation has already shown its feasibility and effectiveness for total hip and knee arthroplasty. Studies on telerehabilitation for patients with shoulder disorders, and more specifically shoulder arthroplasty, are scarce, and none was performed using a smartphone-based app. Before surgery, 60 patients assigned for TSA will be randomly allocated in 2 equal groups. After surgery, the intervention group will daily use a smartphone application to rehabilitate. The control group will have the usual care of 2 physical therapy sessions a week, complemented with home exercise therapy. The primary outcome will be function and pain measured by the Shoulder Pain and Disability Index-Dutch Version (SPADI-DV). Secondary outcomes will include active and passive range of motion, strength, adherence to therapy, self-efficacy for exercise, and functional independence. In collaboration with a licensed company (moveUP Coach by moveUP®, Brussels, Belgium), a smartphone rehabilitation application was developed specifically for rehabilitation after total shoulder arthroplasty. A randomized control trial will compare the (functional) outcome after rehabilitation with the app with standard physical therapy. All patients will be tested at specific moments to evaluate functional progression, self-efficacy, and compliance. ClinicalTrials.gov NCT 05699031. Registered on 23/12/2022