Coping to Move Again: The Psychological Dimension of Tele-Supported Rehabilitation After Knee Arthroplasty - A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- VAS (Pain assessment)
Study Overview
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.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 50 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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°).
Arms & Interventions
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.
Intervention: personalized outpatient rehabilitation treatment after TKA (Procedure)
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.
Intervention: standard outpatient rehabilitation treatment after TKA (Procedure)
Outcomes
Primary Outcomes
VAS (Pain assessment)
Time Frame: At baseline (T0), at 1.5 months (T1), and at 3 months (T2)
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.
Western Ontario and McMaster Universities Arthritis Index (Physical function)
Time Frame: At baseline (T0), at 1.5 months (T1), and at 3 months (T2)
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);
Knee Injury and Osteoarthritis Outcome Score (Knee function)
Time Frame: At baseline (T0), at 1.5 months (T1), and at 3 months (T2)
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).
Secondary Outcomes
- 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))
- Patient Activation Measure (Patient activation in managing their illness)(At baseline (T0))
- Caregiver/Activation Scale (Caregiver activation)(At baseline (T0))
- COPing Orientation to Problems Experienced-Italian Version (Assessment of coping styles)(At baseline (T0))
- Technology Acceptance Model (Technological attitude)(At baseline (T0))
Investigators
Laura Belinda Rizzo
Principal Investigator
University of Bari Aldo Moro