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

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

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.

Study Overview

• Status: Completed
• Conditions: Arthrosis of the Knee
• Intervention / Treatment: Procedure: standard outpatient rehabilitation treatment after TKA; Procedure: personalized outpatient rehabilitation treatment after TKA

Detailed Description

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 July and October 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 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 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. Data Profile: Since variables are non-normally distributed (Shapiro-Wilk test), the study uses non-parametric methods. Data is expressed as medians (IQR) or frequencies (%).

Baseline Comparisons: Groups are compared via the Mann-Whitney U test (continuous) and χ 2 or Fisher's exact tests (categorical). Longitudinal Analysis: Clinical outcomes over time (T0-T2) are evaluated using a non-parametric mixed-effects model to analyze time, group, and their interaction. Changes & Correlations: Relative variation is calculated as Δ=(T 2-T0)/T0. Its relationship with baseline psychological scores is assessed via Spearman's correlation. Thresholds: Analyses are performed in R (v4.2), using a significance threshold of p<0.05.

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Bari
    • Adelfia, Bari, Italy, 70071
      • Presidio territoriale di recupero e riabilitazione funzionale "San Giovanni di Dio" Conssi welfare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: outpatient rehabilitative treatment plus tele-rehabilitation; 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; personalized outpatients rehabilitation treatment after TKA, including psychomotivational framing, and telemedicine-based rehabilitation interventions
Active Comparator: Standard outpatient rehabilitative treatment; 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; standard outpatient rehabilitation treatment after TKA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Barthel Index (Activities of daily living)	The Barthel Index (BI) for Activities of Daily Living is an ordinal scale that measures a person's ability to perform daily activities through 10 items. Each item is rated by the evaluator based on the individual's capacity to complete the task independently, with assistance, or not at all, with scores as follows:0=unable, 1=needs assistance, 2=independent. The total scores are on a scale from 0 to 100. Interpretation of dependency levels: 0 to 20: Total dependence/21 to 60:Severe dependence/61 to 90:Moderate dependence/91 to 99:Slight dependence.	At baseline (T0), at 1.5 months (T1), and at 3 months (T2)
Modified Rankin Scale (Degree of disability in daily activities)	The Modified Rankin Scale (mRS) measures the degree of disability, scored from 0 to 6: 0:No symptoms/1:No significant disability despite symptoms/2:Slight disability; unable to perform all previous activities but able to manage own affairs without assistance/3:Moderate disability; requires some help but can walk without assistance/4:Moderately severe disability/5:bedridden, incontinent, and requiring constant care and assistance/6: Dead	At baseline (T0), at 1.5 months (T1), and at 3 months (T2)
Credibility/Expectancy Questionnaire (psychological and behavioral assessment)	The Credibility/Expectancy Questionnaire(CEQ)measures treatment expectancy and the credibility.It assesses two aspects:cognitive aspects as the reliability of the treatment and emotional aspects, as the belief in improvement related to the treatment.	At baseline (T0)
COPing Orientation to Problems Experienced-Italian Version (Assessment of coping styles)	The COPing Orientation to Problems Experienced-Italian Version(COP-NIV)explores five main independent dimensions. It consists of 60 items assessing how individuals react to stressful events, rated on a 4point scale	At baseline (T0)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analgesia	Each patient must complete a diary in which they will record their daily consumption of any analgesic medications taken for knee pain throughout the study period, from start to finish. They will report the total consumption weekly and monthly (over 12 weeks / 3 months) and specify the type of medication (paracetamol/NSAIDs/corticosteroids/opioids/muscle relaxants).	At 1.5 months (T1) and at 3 months (T2)
Abandonment of mobility aids	the complete discontinuation of any prescribed mobility aids will be documented.	At 1.5 months (T1) and at 3 months (T2)
Demographic indicators	age, gender, education level, marital status, employment status, presence of a caregiver	At baseline (T0)

Collaborators and Investigators

• Sponsor: Laura Belinda Rizzo
• Collaborators: Università degli Studi 'G. d'Annunzio' Chieti e Pescara
• Investigators: Study Director: Marisa Megna, Professor, University Bari "A. Moro"; Study Director: Teresa Paolucci, Research, University of Chieti-Pescara "G. D'Annunzio"; Principal Investigator: Laura B Rizzo, MD, University of Bari "A. Moro"

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2025
• Primary Completion (Actual): October 31, 2025
• Study Completion (Actual): October 31, 2025

Study Registration Dates

• First Submitted: May 5, 2025
• First Submitted That Met QC Criteria: June 18, 2025
• First Posted (Actual): June 24, 2025

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: rehabilitation; telemedicine; physical function; primary osteoarthritis; discontinuation of walking aids; Reduction of pain; psycho-behavioral assessments; attitude toward technology; use of analgesics
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis
• Other Study ID Numbers: Prot.2114/CEL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No