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

To ensure quality and ethical standards in the design and implementation of our randomized clinical trial (RCT), we will apply the Helsinki criteria and the CONSORT checklist. All patients hospitalized for rehabilitation after total knee arthroplasty (TKA) at the San Giovanni di Dio Rehabilitation Center in Adelfia (BA) will be evaluated for eligibility to participate in a clinical study on primary symptomatic osteoarthritis (OA) of the knee between February and May 2025. Inclusion criteria (in addition to those already mentioned in the brief summary): Ability to stand on one leg. Exclusion criteria: Post-traumatic or inflammatory knee OA. Valgus/varus deformity (hip-knee-ankle angle \> or \< 10°). The control group and the study group, after medical, physiotherapeutic, and psychological assessment, will undergo a posturographic examination and will then receive a treatment focused on strengthening lower limb muscles, improving joint range of motion, enhancing balance, and gait training. This will be delivered in two physiotherapy sessions per day, each lasting 45 minutes, during the 22-25 days of hospitalization. Following discharge, participants will receive outpatient treatment consisting of two 45-minute sessions per week for three months at a physiotherapy clinic. The control group will follow this program as usual, while the study group will have the same program reinforced with home supervision via telemedicine. A physiotherapist, trained on the initial posturography findings and psychological assessments, will conduct teleconsultations using Zoom (with end-to-end encryption). Patient characteristics and outcome measures will be reported in aggregate form, as mean ± standard deviation for continuous variables and absolute frequencies (percentages) for categorical variables. Statistical analysis of outcomes will include testing the significance of differences. The two groups will be compared based on baseline characteristics and changes in outcomes. The Wilcoxon signed-rank test will be used to evaluate intra-group differences and the effects of the physiotherapy program. The Mann-Whitney U test will be employed to assess differences between groups and evaluate the effect of tele-rehabilitation. The chi-square (χ²) test will be used to verify the homogeneity of categorical variable distributions across the two groups. Statistical significance will be set at p \< 0.05. The effect size (ES) for the Mann-Whitney U test will be calculated in the case of between-group comparisons.