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

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.

Conditions

• Arthrosis of the Knee

Interventions

PROCEDURE

personalized outpatient rehabilitation treatment after TKA

personalized outpatients rehabilitation treatment after TKA, including psychomotivational framing, and telemedicine-based rehabilitation interventions

PROCEDURE

standard outpatient rehabilitation treatment after TKA

standard outpatient rehabilitation treatment after TKA

Sponsors & Collaborators

• Università degli Studi 'G. d'Annunzio' Chieti e Pescara

  collaborator OTHER

• Laura Belinda Rizzo

  lead OTHER

Principal Investigators

• Marisa Megna, Professor · University Bari "A. Moro"

• Teresa Paolucci, Research · University of Chieti-Pescara "G. D'Annunzio"

• Laura B Rizzo, MD · University of Bari "A. Moro"

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

50 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-07-01

Primary Completion

2025-10-31

Completion

2025-10-31

Countries

• Italy

Study Locations