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

NCT07032805 | Completed

• 1 other identifier: Prot.2114/CEL
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

telemedicine; primary osteoarthritis; rehabilitation; discontinuation of walking aids; Reduction of pain; physical function; psycho-behavioral assessments; attitude toward technology; use of analgesics

Outcome Measures

Primary Outcomes (3)

• VAS (Pain assessment)

  We will use the VAS (Visual Analogue Scale) to quickly and reliably determine the pain perceived by the patient. The VAS (Visual Analogue Scale) consists of a horizontal line 10 centimeters long, with two endpoints representing opposite levels of sensation. Zero is at the extreme left, indicating "No pain," and ten is at the extreme right, representing "The worst pain imaginable." The patient subjectively expresses their perception of pain by indicating a point on the line.

  At baseline (T0), at 1.5 months (T1), and at 3 months (T2)

• Western Ontario and McMaster Universities Arthritis Index (Physical function)

  The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is a patient-reported outcome questionnaire that assesses symptoms and activity limitations in osteoarthritis or following joint replacement surgery. It evaluates the severity of pain, joint stiffness, and physical function with 24 questions, each using a Likert scale ranging from 0 (no symptoms) to 4 (high intensity or difficulty);

  At baseline (T0), at 1.5 months (T1), and at 3 months (T2)

• Knee Injury and Osteoarthritis Outcome Score (Knee function)

  The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a self-administered questionnaire that assesses symptoms related to the knee joint in osteoarthritis and after total knee replacement surgery. The scale consists of 42 items that evaluate symptoms, pain, daily life functions and activities, sports and recreational activities, and quality of life related to the knee. Responses are on a 5-point Likert scale ranging from 0 (no problems or difficulties) to 4 (severe problems or difficulties).

  At baseline (T0), at 1.5 months (T1), and at 3 months (T2)

Secondary Outcomes (4)

• Barthel Index (Activities of daily living)

  At baseline (T0), at 1.5 months (T1), and at 3 months (T2)

• Modified Rankin Scale (Degree of disability in daily activities)

  At baseline (T0), at 1.5 months (T1), and at 3 months (T2)

• Credibility/Expectancy Questionnaire (psychological and behavioral assessment)

  At baseline (T0)

• COPing Orientation to Problems Experienced-Italian Version (Assessment of coping styles)

  At baseline (T0)

Study Arms (2)

outpatient rehabilitative treatment plus tele-rehabilitation

EXPERIMENTAL

The study group will undergo medical, physiotherapeutic, and psychological assessment. They will then receive a treatment focused on strengthening lower limb muscles, improving joint range of motion, enhancing balance, and developing walking ability. This will be delivered in two daily physiotherapy sessions, each lasting 45 minutes, over the 22-25 days of hospitalization. After discharge, they will continue outpatient treatment with two 45-minute sessions per week for three months at a physiotherapy clinic. Additionally, they will receive home supervision from a physiotherapist via telemedicine (video calls using Zoom with encryption), trained on the patient's initial issues identified through psychological evaluation.

Procedure: personalized outpatient rehabilitation treatment after TKA

Standard outpatient rehabilitative treatment

ACTIVE COMPARATOR

The control group will undergo medical, physiotherapeutic, and psychological assessments. They will then receive treatment focused on strengthening lower limb muscles, improving joint range of motion, enhancing balance, and gait training. This will be administered in two physiotherapy sessions per day, each lasting 45 minutes, over the 22-25 days of hospitalization. After discharge, they will continue with outpatient physiotherapy consisting of two 45-minute sessions per week for three months at an outpatient physiotherapy clinic.

Procedure: standard outpatient rehabilitation treatment after TKA

Interventions

standard outpatient rehabilitation treatment after TKA PROCEDURE

standard outpatient rehabilitation treatment after TKA

Standard outpatient rehabilitative treatment

personalized outpatient rehabilitation treatment after TKA PROCEDURE

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

outpatient rehabilitative treatment plus tele-rehabilitation

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Recent unilateral total knee arthroplasty;
• Body Mass Index (BMI) \< 35;
• Ability to stand on one leg;
• Absence of active known neurological or oncological diseases.

You may not qualify if:

• Post-traumatic or inflammatory knee osteoarthritis (OA);
• Valgus/varus deformity (hip-knee-ankle angle \> or \< 10°).

Sponsors & Collaborators

• Laura Belinda Rizzo: lead
• Università degli Studi 'G. d'Annunzio' Chieti e Pescara: collaborator

Study Sites (1)

Presidio territoriale di recupero e riabilitazione funzionale "San Giovanni di Dio" Conssi welfare

Adelfia, Bari, 70071, Italy

Location

Study Officials

• Marisa Megna, Professor

  University Bari "A. Moro"

  STUDY DIRECTOR

• Teresa Paolucci, Research

  University of Chieti-Pescara "G. D'Annunzio"

  STUDY DIRECTOR

• Laura B Rizzo, MD

  University of Bari "A. Moro"

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 5, 2025
• First Posted: June 24, 2025
• Study Start: July 1, 2025
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)