Clinical Research Directory

Study on Personalized Total Knee Arthroplasty (TKA) Rehabilitation Using Telemedicine and Psychoeducation

Sponsor: Laura Belinda Rizzo

Summary

The aim of this clinical study is to evaluate the effectiveness of a telemedicine approach in improving treatment adherence and functional outcomes in patients recently underwent total knee replacement for primary osteoarthritis. The study focuses on patients aged between 50 and 75 years, with a BMI below 35, and without known oncological or neurological conditions. Participants will receive a personalized rehabilitation program, including initial assessment, psychomotivational framing, and rehabilitation interventions based on telemedicine. The goal is to provide a framework for adopting more detailed and personalized rehabilitative strategies.The main research questions are:• Primary: pain reduction (VAS), physical function (WOMAC, KOOS).• Secondary: activities of daily living (Barthel index, mRS); psychobehavioral assessments (CEQ, PAM13, CG-PAM, COP-NIV); attitude towards technology (TAM); use of analgesics and walking aids.Sample size is estimated at 40 patients (20 per group), accounting for a 20% dropout rate, divided into:• Control group: standard outpatient rehabilitation with a personalized exercise program.• Study group: standard outpatient rehabilitation with a personalized exercise program plus telemonitoring via video calls. Procedures:• Recruitment and signing of informed consent; • Initial assessment (demographic data, baseline tests) and start of post-acute rehabilitation during hospitalization at T0;• Outpatient rehabilitation interventions with/without tele-rehabilitation support (twice weekly) at discharge, with follow-up assessments at T1 (1.5 months) and T2 (3 months);• Weekly recording of analgesic consumption through a dedicated diary;• Recording the date of discontinuation of walking aids.

Official title: Coping to Move Again: The Psychological Dimension of Tele-Supported Rehabilitation After Knee Arthroplasty - A Randomized Controlled Trial

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