Telemedicine in Personalized Home Rehabilitation Following Total Knee Arthroplasty (TKA): a Pilot Study
Phase: NA
Conditions: Arthrosis of the Knee
Sponsor: Laura Belinda Rizzo

 
 
Versione n.1_novembre 2024                      
 
PRESIDIO TERRITORIALE DI RECUPERO E 
RIABILITAZIONE FUNZIONALE 
“SAN GIOVANNI DI DIO” - Adelfia (BA) 
Dsmob/ Univ. degli studi di Chieti-Pescara  
Scuola di spec. Medicina fisica e riabilitativa 
Univ. degli studi di Bari (DiBrain) 
 
 
STUDY PROTOCOL AND STATISTICAL ANALISYS PLAN 
 
 
 
 
TELEMEDICINE IN PERSONALIZED HOME-
BASED REHABILITATIVE TREATMENT 
AFTER TOTAL KNEE REPLACEMENT (TKA): 
PILOT STUDY 
 
NCT number: Prot.2114/CEL 
document date: February 26, 2025 
 
 
 
 
 
 
 

 
 
Versione n.1_novembre 2024                      
 
PRESIDIO TERRITORIALE DI RECUPERO E 
RIABILITAZIONE FUNZIONALE 
“SAN GIOVANNI DI DIO” - Adelfia (BA) 
Dsmob/ Univ. degli studi di Chieti-Pescara  
Scuola di spec. Medicina fisica e riabilitativa 
Univ. degli studi di Bari (DiBrain) 
 
Title of the study: Telemedicine in personalized home-based rehabilitative treatment after total knee replacement 
(TKA): pilot study. 
 
Introduction: Knee osteoarthritis (OA) is the most common form of diagnosed arthritis, with increasing incidence due 
to its association with aging and obesity in the general population. [1] The percentage of affected individuals reaches 
approximately 40% in populations over 70 years old. [1] The prevalence is higher among women. [1] Common 
symptoms include, besides pain, reduced range of motion (ROM) or joint locking, crepitus or noises during movement, 
decreased strength, swelling, and instability, which also lead to negative psychological impacts, contributing to 
decreased daily activity, mobility, and an overall reduction in quality of life. [2] In the pathogenesis of OA, proteolytic 
enzymes (matrix metalloproteinases, MMPs) are involved, with increased production caused by various factors. 
Initially, chondrocytes can partially compensate by increasing proteoglycan production and tissue inhibitors of 
metalloproteinases (TIMPs). Unfortunately, when the direct cause cannot be addressed, this compensation is 
insufficient to restore the balance between cartilage synthesis and degradation. Consequently, proteoglycan levels 
decrease, the collagen structure becomes brittle, and degenerative phenomena such as fissuring or tearing of the 
cartilage layer, as well as subchondral cartilage damage, begin to occur. Although these features are typically used to 
quantify disease severity, OA affects almost all other components of the knee, including ligaments, menisci, nerves, 
and muscles acting on the joint. [3] Based on etiology, two categories of OA exist: primary, non-traumatic or 
idiopathic; and secondary, mainly due to mechanical misalignment or trauma. 
Treatment options for knee OA include conservative or surgical approaches. Non-surgical treatments can be 
pharmacological or non-pharmacological. Non-pharmacological therapies often start with weight loss, followed by 
physical activity, which alone can reduce pain and improve quality of life. [4] [5] Strengthening exercises targeting 
stabilizer muscles of the knee (particularly the quadriceps) aim to reduce the load transferred directly onto the joint 
during movement, thereby decreasing joint stress. [6] A recent review demonstrated that physical exercise is an 
effective therapy for individuals with early-stage knee OA. [7] [8] Despite the importance of non-pharmacological 
strategies, less than 40% of patients with knee OA receive such approaches. [9] One reason for this low utilization is 
limited access to rehabilitation, especially when in-person attendance is challenging. Therefore, the World Health 
Organization recommends digital interventions to complement traditional healthcare, aiming to improve access for 
broader populations. [10] Recent literature shows that both in-person and digital treatments can lead to clinically 
significant improvements in pain. [11] OA is a leading cause of disability and has a high economic impact, both in 
direct costs (medications, surgeries) and indirect costs (lost income, increased expenses). [12] [13] Advances in digital 
health technologies through digital platforms can enable the delivery of primary care interventions aligned with global 
guidelines, potentially at reduced costs compared to traditional care models. [14] 

 
 
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PRESIDIO TERRITORIALE DI RECUPERO E 
RIABILITAZIONE FUNZIONALE 
“SAN GIOVANNI DI DIO” - Adelfia (BA) 
Dsmob/ Univ. degli studi di Chieti-Pescara  
Scuola di spec. Medicina fisica e riabilitativa 
Univ. degli studi di Bari (DiBrain) 
Another challenge limiting the use of this effective therapeutic strategy is inconsistent adherence to treatment plans. 
Factors influencing poor adherence include fluctuating symptoms, comorbidities, personal motivation, and individual 
goals, which need to be explored to incorporate patient-centered objectives into personalized rehabilitation programs. 
[14] In addition to psychological and emotional factors, clinical examinations and posturography analysis are 
recommended for planning conservative interventions in OA patients. [15] [16] [17] Limited access to early treatments, 
combined with their proven effectiveness in pain reduction and optimal recovery of activities of daily living (e.g., 
walking), contributes to the increasing number of total knee arthroplasties (TKA) performed annually. [18] [19] 
Postoperative deficits in balance components, such as reduced proprioception, decreased postural control, and slower 
muscle activation, have been documented. [20] [21] A recent study highlights the utility of posturographic assessment 
in developing targeted rehabilitation programs to compensate for postural deficits and improve gait performance. [22] 
Tele-rehabilitation has been shown to be as effective as face-to-face therapy in controlling pain and improving 
functional recovery after TKA. [23] 
 
Study Objectives: The primary aim is to demonstrate that adherence and, consequently, functional outcomes (pain 
reduction and limitations) at short- and long-term follow-up improve with a personalized exercise program that 
includes psychological-motivational assessment and development of personalized exercises based on posturographic 
analysis. This program is supported via digital therapy through tele-rehabilitation, leading to pain reduction and 
decreased medication use (project: Sy-Di-DOA). 
 
Materials and Methods: To ensure quality and ethical standards in the design and implementation of our randomized 
controlled trial (RCT), we will adhere to the Helsinki criteria and the CONSORT checklist. All patients admitted for 
rehabilitation following Total Knee Arthroplasty (TKA) at the San Giovanni di Dio Rehabilitation Center in Adelfia 
(BA) will be evaluated for eligibility to participate in an RCT for primary symptomatic osteoarthritis (OA) of the knee 
between October-November 2024 and March 2025.  
Inclusion criteria:   
Age between 50 and 75 years;   
Recent unilateral total knee arthroplasty;   
Body Mass Index (BMI) < 35 [24];   
Ability to stand on one leg;  
Absence of known active neurological or oncological diseases.  
 
Exclusion criteria:  
Traumatic or inflammatory knee OA;   

 
 
Versione n.1_novembre 2024                      
 
PRESIDIO TERRITORIALE DI RECUPERO E 
RIABILITAZIONE FUNZIONALE 
“SAN GIOVANNI DI DIO” - Adelfia (BA) 
Dsmob/ Univ. degli studi di Chieti-Pescara  
Scuola di spec. Medicina fisica e riabilitativa 
Univ. degli studi di Bari (DiBrain) 
Valgus/varus deformity (hip-knee-ankle angle > or < 10°).  
The control group, after medical and physiotherapeutic assessment, will undergo a posturographic examination and 
then receive a personalized treatment aimed at strengthening the specific muscles of the lower limbs, improving the 
range of motion of the joint, and enhancing balance and gait in two physiotherapy sessions per day, each lasting 45 
minutes, during the 22-25 days of hospitalization. This will be followed post-discharge by an outpatient standard 
treatment consisting of two sessions per week, each lasting 45 minutes, for the subsequent weeks up to three months 
from T0 at a physiotherapy outpatient clinic [25]. 
The study group, in addition to the aforementioned assessments, will receive a personalized treatment aimed at 
specifically strengthening the muscles of the lower limbs, improving the range of motion of the joint, enhancing 
balance, and optimizing gait in the same manner and for the same duration. At the end of the hospitalization, 
continuation of the outpatient rehabilitation treatment is planned with a personalized program of two sessions per week, 
each lasting 45 minutes, for the following weeks up to three months from T0, supervised at home by a physiotherapist 
via telemedicine (a video call using Zoom as the videoconferencing software with encryption). [25] 
 
Sample Size Calculation: A target sample size of 40 patients (20 in each group) has been calculated to achieve at least 
90% power to detect a difference of 1.7 points with a standard deviation of 1.3 in the VAS score between the study 
and control groups. This calculation assumes a bilateral test and an alpha level (α) of 0.01, accounting for a 20% 
dropout rate. The calculation references a previous study. 
 
Statistical Analysis: The primary outcome will be the difference in improvement of function as measured by the 
WOMAC and KOOS tests, as well as the assessment of reduction in resting pain intensity measured with the VAS 
scale before total knee arthroplasty (TKA) and at 12 weeks in both the study and control groups. 
Secondary outcomes will include the improvement in independence in activities of daily living before and after the 
therapeutic intervention in both groups, assessed using the Barthel index and the mRS; the psychobehavioral 
assessment at the time of recruitment using the CEQ, COP-NIV, PAM13, CG-PAM scales; and attitudes towards 
technology 
recorded 
with 
the 
TAM 
scale 
at 
recruitment. 
An additional evaluation will examine analgesic consumption throughout the study duration in both groups and the 
time to discontinuation of any prescribed mobility aids. 
Patient characteristics and outcome measures will be reported in aggregated form: mean ± standard deviation for 
continuous variables and absolute frequencies (percentages) for categorical variables. The statistical analysis of 
outcomes will assess the significance of differences between groups and within groups over time. Initial characteristics 
and changes in outcomes will be examined and compared. 

 
 
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PRESIDIO TERRITORIALE DI RECUPERO E 
RIABILITAZIONE FUNZIONALE 
“SAN GIOVANNI DI DIO” - Adelfia (BA) 
Dsmob/ Univ. degli studi di Chieti-Pescara  
Scuola di spec. Medicina fisica e riabilitativa 
Univ. degli studi di Bari (DiBrain) 
The Wilcoxon signed-rank test for paired samples will be used to evaluate intra-group differences and the effect of the 
physiotherapy program. The Mann-Whitney U test for two independent samples will assess the significance of 
differences between groups and evaluate the inter-group effect of telerehabilitation. The χ² test will be employed to 
verify the homogeneity of categorical variable distributions across the two arms. 
Statistical significance will be set at p < 0.05. The effect size (ES) for the Mann-Whitney U test will be calculated in 
the case of inter-group comparisons. 
Each patient will only participate in the study after signing the informed consent form for participation. Each 
participant will be invited to complete a diary in which they will record their daily consumption of any analgesic 
medications taken for knee pain during the study period, from start to finish. They will report the total weekly and 
monthly 
consumption 
(12 
weeks 
/ 
3 
months), 
specifying 
the 
type 
of 
drug 
(paracetamol/NSAIDs/corticosteroids/opioids/myorelaxants). Additionally, the complete discontinuation of any 
prescribed mobility aids will be recorded. 
At evaluation times T0 (study admission), T1 (1.5 months), and T2 (3 months), both groups will be assessed on the 
following aspects: 
Pain intensity using the Visual Analog Scale (VAS), which is a unidimensional psychometric scale for self-assessment 
of pain intensity. It consists of a 10 cm horizontal line marked with two verbal descriptors: one indicating the absence 
of pain perception, and the other representing the maximum pain intensity experienced. The patient marks on the line 
the point that reflects the intensity of the symptom perceived at the time of assessment [26]. 
Using the same evaluation times, the following tests will be administered: 
• 
The Western Ontario and McMaster Universities Arthritis Index (WOMAC): a patient-reported 
outcome measure (PRO) designed to identify changes in symptoms and activity limitations in 
individuals with hip or knee osteoarthritis, even after joint replacement surgery. It has demonstrated 
strong psychometric properties. The WOMAC consists of 24 items divided into 3 subscales: Pain (5 
items assessing pain intensity related to various activities or positions), Stiffness (2 items evaluating 
stiffness in different circumstances), and Physical Function (17 items assessing difficulty 
experienced during specific activities). All items are rated on a Likert scale from 0 (no symptoms) 
to 4 (high intensity or difficulty) [27]. 
• 
The Knee Injury and Osteoarthritis Outcome Score (KOOS): a self-administered questionnaire 
designed to evaluate symptoms related to knee joint injuries or osteoarthritis. It is also valid for 
patients who have undergone total knee arthroplasty. KOOS is considered a reliable tool for assessing 
the impact of knee conditions on daily life and overall function. The scale comprises 42 items across 
5 subscales: Symptoms (7 items, 2 related to stiffness), Pain (9 items), Function in daily living (17 
items), Sport and recreation (5 items), and Quality of life related to the knee (4 items). All items use 

 
 
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PRESIDIO TERRITORIALE DI RECUPERO E 
RIABILITAZIONE FUNZIONALE 
“SAN GIOVANNI DI DIO” - Adelfia (BA) 
Dsmob/ Univ. degli studi di Chieti-Pescara  
Scuola di spec. Medicina fisica e riabilitativa 
Univ. degli studi di Bari (DiBrain) 
the same response format, employing a 5-point Likert scale from 0 (no problems/difficulties) to 4 
(severe problems/difficulties) [28]. 
• 
The Barthel Index for Activities of Daily Living (BI): an ordinal scale measuring a person's ability 
to complete daily activities through 10 items. Each item is evaluated by the operator based on the 
individual's capacity to perform a task independently, with assistance, or not at all. The assessment 
is as follows: 0 = unable, 1 = needs assistance, 2 = independent. The scores from the ten items are 
summed and multiplied by 5 to obtain a total score out of 100. The interpretative guidelines for 
Barthel scores are: 0-20 indicates "total dependence"; 21-60 "severe dependence"; 61-90 "moderate 
dependence"; 91-99 "slight dependence" [29] [30]. 
• 
The Modified Rankin Scale (mRS): used to measure the degree of disability, typically in patients 
with neurological conditions. The scale is constructed as a variable from 0 to 6: 0 = No symptoms; 
1 = No significant disability despite symptoms; able to perform all usual duties and activities; 2 = 
Slight disability; unable to perform all previous activities but able to handle own affairs without 
assistance; 3 = Moderate disability; requires help but can walk without assistance; 4 = Moderately 
severe disability; unable to walk without assistance and unable to attend to own bodily needs without 
assistance; 5 = Severe disability; bedridden, incontinent, and requiring constant care; 6 = Dead. 
Recently, several tools have been developed for a more systematic assessment of mRS, such as mRS-
9Q. Free online calculators are available [31] [32]. 
At time T0, characteristics such as age, sex, level of education, marital status, employment, and presence of a caregiver 
were investigated. Additionally, during the same period, the willingness to participate in digital treatment was assessed 
using the Technology Acceptance Model (TAM). Patients' credibility and expectations were evaluated through the 
Credibility/Expectancy Questionnaire (CEQ). The activation of the patient regarding their own care was measured 
using the Patient Activation Measure (PAM13), and similar areas of interest within the caregiver were identified using 
the caregiver version of the Patient Activation Measure (GC-PAM). To understand how individuals respond when 
facing difficult or stressful events in life, the "Coping Orientation to Problems Experienced-New Italian Version" 
(COP-NIV) scale was employed. 
• 
The Credibility/Expectancy Questionnaire (CEQ): is a quick and easily administered scale used to 
measure treatment expectancy and the rationale credibility for use in clinical outcome studies. It has 
demonstrated results not only in reducing depressive, anxious, and general symptoms but also in 
increasing therapeutic alliance in physiotherapy [33] [34]. 
This is a self-report questionnaire composed of 6 items grouped into two subscales: i) credibility 
(cognitive focus) and ii) outcome expectation (focus on emotional process). The credibility assesses 
the reliability of the treatment according to the subject, specifically how much they believe they can 

 
 
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PRESIDIO TERRITORIALE DI RECUPERO E 
RIABILITAZIONE FUNZIONALE 
“SAN GIOVANNI DI DIO” - Adelfia (BA) 
Dsmob/ Univ. degli studi di Chieti-Pescara  
Scuola di spec. Medicina fisica e riabilitativa 
Univ. degli studi di Bari (DiBrain) 
trust the treatment to benefit from it and how useful it will be, closely related to the therapeutic 
relationship. The expectation refers to the improvement that the subject believes they can achieve 
from the treatment. The expectation precedes any contact with the therapist and is related to the belief 
about how much improvement they will experience with that particular treatment, considering their 
perceptions before starting the treatment.[35] 
• 
The Patient Activation Measure (PAM13): evaluates the patient's knowledge, skills, and confidence 
in managing their condition. Activation data provide information for designing personalized care 
strategies and interventions (e.g., additional supports or resources).[36] It consists of 13 items on a 
Likert scale. Each item has five response categories with scores ranging from 1 to 5: (1) "Strongly 
disagree," (2) "Disagree," (3) "Agree," (4) "Strongly agree," and (5) "Not applicable." It produces a 
summed score, normalized to 100. The corresponding interpretation is as follows: Level 1 (patients 
feel their role is important: items 1 and 2), Level 2 (patients have the confidence and knowledge to 
act: items 3–8), Level 3 (acting: items 9–11), and Level 4 (maintaining the course under stress: items 
12 and 13).[36] 
• 
The Caregiver/Assistant Activation Scale (CG-PAM): It is a 13-item instrument that addresses the 
same concepts as the PAM, through almost identical questions but from the caregiver's perspective, 
and produces a summed score normalized to 100. The score can fall into one of four levels. The 
result is divided into four levels interpreted similarly to the PAM, but in relation to the caregiver. 
[37] 
• 
The Coping Orientation to Problems Experienced-New Italian Version (COP-NIV): It is a self-
administered questionnaire that considers different coping modalities. It investigates five main 
independent dimensions (social support, avoidance, positive attitude, problem orientation, and 
transcendental orientation). It is composed of 60 items that assess how individuals respond to 
stressful events. For each statement, respondents must indicate how frequently they use that 
particular "strategy" on a 4-point Likert scale. [38] 
• 
The Technology Acceptance Model (TAM): consists of 12 items, with six items measuring Perceived 
Usefulness (PU) and six items measuring Perceived Ease of Use (PEU). PU reflects the extent to 
which a person believes that a technology will improve their work performance, while PEU measures 
how easy a person believes it will be to use the technology. The questions are measured on a scale 
similar to a Likert scale. [39] 
 
Statistical analysis: The characteristics of the patients and the outcome measures will be reported in aggregate form as 
mean ± standard deviation for continuous variables and absolute frequencies (percentages) for categorical variables. 

 
 
Versione n.1_novembre 2024                      
 
PRESIDIO TERRITORIALE DI RECUPERO E 
RIABILITAZIONE FUNZIONALE 
“SAN GIOVANNI DI DIO” - Adelfia (BA) 
Dsmob/ Univ. degli studi di Chieti-Pescara  
Scuola di spec. Medicina fisica e riabilitativa 
Univ. degli studi di Bari (DiBrain) 
The statistical analysis of outcomes will include the significance of differences. The initial characteristics and changes 
in outcomes between the two groups will be examined and compared. The Wilcoxon signed-rank test will be used to 
assess intra-group differences and the effect of the physiotherapy program. The Mann-Whitney U test for independent 
samples will be used to detect the significance of differences between groups and to evaluate the inter-group difference 
and the effect of tele-rehabilitation. The χ² test will be used to verify the homogeneity of the distribution of categorical 
variables across the two arms. Statistical significance will be set at p < 0.05, and the Effect Size (ES) for the Mann-
Whitney U test will be calculated in the case of inter-group comparisons. 
 
Expected results: We anticipate that the collected data will enhance our understanding of patients with recent total 
knee arthroplasty (TKA) due to osteoarthritis (OA), from both structural and behavioral perspectives. This knowledge 
will allow us to adapt more effective rehabilitative strategies at the time of discharge from dedicated centers, utilizing 
telemedicine to improve interventions and further reduce costs. 
 
Study location: Presidio territoriale di recupero e riabilitazione funzionale “San Giovanni di Dio” ex art. 26 L. n. 
833/1978, operational headquarters: trav. di via Fieno, 5 Adelfia (Ba) (Territorial rehabilitation and recovery center 
for individuals with physical, psychological, sensory, or mixed disabilities “San Giovanni di Dio”, authorized to 
operate and with institutional accreditation from ASL Bari, equipped with 60 beds for intensive rehabilitation for 
adults). 
 
Type of study: randomized controlled trial (RCT). 
 
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PRESIDIO TERRITORIALE DI RECUPERO E 
RIABILITAZIONE FUNZIONALE 
“SAN GIOVANNI DI DIO” - Adelfia (BA) 
Dsmob/ Univ. degli studi di Chieti-Pescara  
Scuola di spec. Medicina fisica e riabilitativa 
Univ. degli studi di Bari (DiBrain) 
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PRESIDIO TERRITORIALE DI RECUPERO E 
RIABILITAZIONE FUNZIONALE 
“SAN GIOVANNI DI DIO” - Adelfia (BA) 
Dsmob/ Univ. degli studi di Chieti-Pescara  
Scuola di spec. Medicina fisica e riabilitativa 
Univ. degli studi di Bari (DiBrain) 
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Versione n.1_novembre 2024                      
 
PRESIDIO TERRITORIALE DI RECUPERO E 
RIABILITAZIONE FUNZIONALE 
“SAN GIOVANNI DI DIO” - Adelfia (BA) 
Dsmob/ Univ. degli studi di Chieti-Pescara  
Scuola di spec. Medicina fisica e riabilitativa 
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