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TKA
Coping to Move Again: The Psychological Dimension of Tele-Supported Rehabilitation After Knee Arthroplasty - A Randomized Controlled Trial
Sponsor study identifier
interventional
44
1 country
1
Study Start
July 1, 2025
Actual (reported)Primary Completion
October 31, 2025
Actual (reported)Study Completion
October 31, 2025
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 31, 2025
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 5, 2025
Actual (reported)June 24, 2025
Actual (reported)July 1, 2025
Actual (reported)October 31, 2025
Actual (reported)October 31, 2025
Actual (reported)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).
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)
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.
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.
personalized outpatients rehabilitation treatment after TKA, including psychomotivational framing, and telemedicine-based rehabilitation interventions
standard outpatient rehabilitation treatment after TKA
Presidio territoriale di recupero e riabilitazione funzionale "San Giovanni di Dio" Conssi welfare
Adelfia, Bari, 70071, Italy
Paolucci T, Rizzo LB, Cichelli A, Bressi F, Bernetti A, Fari G, Megna M, Bonerba M, Marotta A, Di Nicola M. Coping to move again: the psychological dimension of tele-supported rehabilitation after knee arthroplasty-A randomized controlled trial. Front Digit Health. 2026 Jul 23;8:1885446. doi: 10.3389/fdgth.2026.1885446. eCollection 2026.
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"
44 participants (actual enrollment reported by the registry).
First Submitted
May 5, 2025
First Posted
June 24, 2025
Study Start
July 1, 2025
Actual (reported)At baseline (T0), at 1.5 months (T1), and at 3 months (T2)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
October 31, 2025
Actual (reported)Study Completion
October 31, 2025
Actual (reported)Last Updated
May 11, 2026
Record last verified: 2026-05
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Source: ClinicalTrials.gov.
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