Feasibility and acceptability of a telerehabilitation intervention on patients undergoing total knee arthroplasty in Iran: randomised controlled trial protocol

STRENGTHS AND LIMITATIONS OF THIS STUDY

  • This study focuses on telerehabilitation, an innovative therapeutic approach that faces unique challenges in different cultural contexts.

  • This study will be the first feasibility and acceptability study in Iran to examine implementing telerehabilitation for patients who have undergone total knee arthroplasty.

  • The study will utilise a software platform designed to meet the needs of patients and therapists, incorporating input from experts in therapeutic fields and software design.

  • While blinding is possible for statistical analysis and outcome assessment, the nature of the intervention prevents blinding of the physiotherapist interventionist.

Introduction

Knee osteoarthritis (KOA) is a prevalent degenerative joint disease characterised by the gradual loss of cartilage in the knee joint, resulting in pain, stiffness and impaired mobility.1 In the year 2020, approximately 654.1 million individuals aged 40 years and older worldwide were affected by KOA.2 Total knee arthroplasty (TKA) is a highly effective surgical intervention for the treatment of severe KOA that has not responded to non-surgical treatments.3 TKA has demonstrated significant improvements in pain reduction, functional restoration and enhancement of quality of life (QoL) for patients with KOA.4 However, following TKA, patients experience limitations and restrictions in movement due to decreased muscle strength.5 For instance, 1 month after TKA, muscle function is reduced by approximately 20%–25%.6 Even after 1 year, muscle function remains lower compared with healthy adults, as evidenced by an 18% decrease in walking speed and a 51% decrease in stair-climbing speed.7 The range of motion (ROM) of the knee joint is also diminished due to postoperative pain, haematoma and swelling.8 Consequently, only 67% of patients achieve complete functional recovery.9 Additionally, the strength of the quadriceps muscle is significantly reduced, with an immediate decrease of 30.7% after TKA and a further decline of 50%–60% after 1 month.10 Therefore, postoperative rehabilitation programmes can play a critical role in improving function, outcomes and mobility in TKA patients.11 These programmes encompass various fitness components, including exercises targeting joint ROM, muscle strength, walking, function, endurance and balance.12 The restoration of all these components is imperative for achieving full recovery following TKA.5 The initiation of rehabilitation can commence as early as the day after surgery and may continue for several months post-procedure.13

In the context of increasing telemedicine usage in healthcare, telerehabilitation has emerged as a promising and effective means of delivering rehabilitation services to patients after TKA.14 Telerehabilitation involves employing technology, such as videoconferencing and mobile health apps, to remotely administer rehabilitation services to patients in their homes.15 There is a growing interest in the utilisation of telerehabilitation for managing KOA, particularly in the post-TKA phase.16 The results of numerous studies indicate that telerehabilitation can be an effective approach to improving outcomes and minimising complications after TKA. These include pain relief, enhanced functional capabilities and addressing limitations in ROM.17 18 Telerehabilitation offers increased accessibility, convenience and cost reduction for patients.19 By eliminating the need for travel to rehabilitation appointments, telerehabilitation overcomes obstacles associated with distance, transportation and scheduling conflicts commonly encountered in in-person rehabilitation.20 These potential benefits make telerehabilitation a promising approach for post-TKA patients, offering convenient and affordable care that improves accessibility and enhances overall recovery,21 as the utilisation of telemedicine continues to grow and evolve, telerehabilitation is poised to become an increasingly important and effective method of delivering rehabilitation services to post-TKA patients.15 22

Despite the development of various software and hardware infrastructures for providing telerehabilitation services in numerous countries,23–29 indigenous software platforms in Iran have not yet been thoroughly examined in accordance with the culture and conditions of Iranian society. As far as we know, there is no existing research on the utilisation of telerehabilitation after TKA in Iran, despite the increasing prevalence of KOA.30 Therefore, there is a need to evaluate the feasibility, acceptability and effectiveness of telerehabilitation after TKA in Iran while addressing challenges such as technical issues, concerns regarding patient privacy and data security, personal interaction with healthcare providers and patient adherence to the telerehabilitation programme. Technical issues related to the telecommunication platform can impact the quality of rehabilitation sessions,31 and the absence of personal interaction with healthcare providers may hinder the assessment of patient progress and the provision of personalised feedback. Furthermore, patient adherence to the rehabilitation programme may be compromised due to reduced accountability and motivation associated with telerehabilitation.32 To the best of our knowledge, this study is the first study in Iran that will address these gaps, and this article presents a protocol for a randomised controlled trial (RCT) that aims to investigate the feasibility and acceptability of telerehabilitation among Iranian TKA patients.

Methods and analysis

Study design and setting

This study is a feasibility and acceptability open-label RCT that will be conducted in parallel groups, as depicted in figure 1. The study protocol has been developed in accordance with the Standard Protocol Item: Recommendations for Interventional Trials (SPIRIT) guidelines,33 and the results will be reported following the Consolidated Standards of Reporting Trials (CONSORT) guidelines. The SPIRIT checklist, provided in an additional file (file 1), is included. Participant recruitment will take place at Atieh Hospital, affiliated with the Iran University of Medical Sciences (IUMS), Tehran, Iran. It is worth noting that this study primarily focuses on exploration rather than confirmation, emphasising the use of appropriate analytical methods for pilot data analysis rather than statistical power. Consequently, the study will not seek to draw significant inferences.

Figure 1
Figure 1

Flow diagram of the study. NV, neurovascular.

Eligibility criteria

A physiotherapist interventionist will review the medical records of adult patients in the postoperative care unit after undergoing TKA to assess their eligibility based on the following criteria.

Inclusion criteria

(1) Age between 50 and 90 years old; (2) no prior history of knee replacement; (3) ability to read and write Persian language and (4) access to and be capable of using a personal smartphone or have access to a companion who can use the smartphone, enabling them to utilise the necessary mobile applications for the research and (5) willingness to participate and complete intervention sessions and data collection measures.

Exclusion criteria

(1) Having been diagnosed with rheumatoid arthritis, other systematic inflammatory diseases and neurological disorders; (2) having cognitive disorders documented in the medical record; (3) having uncorrectable vision and hearing disorders; (4) participating in any knee rehabilitation programme outside of the study; (5) any unforeseen complications arising during the intervention that render it impossible to proceed and (6) failure to complete a minimum of 9 out of 12 telerehabilitation sessions for the intervention group (with a minimum attendance rate of 75% for telerehabilitation sessions).

Interventions

In-hospital period

This period encompasses therapeutic interventions administered to the patients during their hospitalisation, uniformly implemented for both intervention and control groups. Procedures at this stage, categorised by different care providers, are outlined in table 1. Irrespective of group assignment, all patients will receive educational pamphlets containing postoperative information. These pamphlets, developed by two orthopaedic surgeons and two physiotherapists from the university faculty, draw from the guidance provided in the book ‘Rehabilitation for the Postsurgical Orthopaedic Patient’,34 and include prescribed exercises, recommendations for resuming activities of daily living (ADLs), potential complications, expected discomforts and responses to frequently asked questions. The validity of the educational pamphlet was evaluated by six faculty members of AJA University of Medical Sciences with expertise in orthopaedic surgery and physiotherapy.

Table 1

The description of the procedures taken for patients during the in-hospital period

Discharge criteria

At the end of this phase, patients will be discharged based on the following criteria: they must demonstrate independent basic mobility, including transfer and walking, with the appropriate walking aid. Additionally, they should experience manageable levels of pain and maintain a stable medical condition before discharge from the hospital.

Surgical method and in-person physiotherapy

All participants will undergo TKA with a uniform application of surgical methodology and prosthesis. The surgical method employed in this study will be minimally invasive surgery. According to the surgeon’s opinion, patients will not receive in-person rehabilitation immediately after surgery. However, during the 2 week postsurgery visit by surgeons Dr Davood Feizi (DF) and Dr Mohammad Mahdi Sarzaeem (MMS), participants will undergo evaluation. This assessment will include the removal of wound dressings and an evaluation of various factors such as pain levels, wound healing progress, ROM in knee flexion and extension, strength of knee flexor and extensor muscles, walking ability and performance of ADLs. The desired outcome for this visit is to achieve satisfactory ROM in both active and passive knee extension, as well as approximately 90 degrees of active and passive knee flexion. Additionally, the goal is to attain relative independence in performing ADLs, with or without the use of assistive devices. Based on the surgeons’ assessment, patients who require in-person physiotherapy will be prescribed such treatment to continue their rehabilitation at physiotherapy centres. Consequently, these individuals will be excluded from further participation in the study.

Intervention group (telerehabilitation)

Patients in the intervention group will undergo online visits 3 days a week, each lasting 30–45 min, for a total of 12 sessions in a 4 week intervention period. This intervention will administer telerehabilitation interventions to the intervention group patients following their hospital discharge. It includes a telerehabilitation programme that utilises virtual physiotherapy visits through the Iranian mobile application ‘Drmyco’, accessible on Android or a web-based platform (https://drmyco.ir/) for iOS or Windows software-based devices.

Drmyco application and website features

‘Drmyco’ is a software programme providing an online platform for consultations with various healthcare specialists in Iran. Both the website and application versions share the same features, which were evaluated by six faculty members of AJA University of Medical Sciences (AJAUMS) with expertise in orthopaedic surgery and physiotherapy. Telerehabilitation sessions will be free for all patients participating in the study. The therapeutic programme will be based on the validated third edition of the book ‘Rehabilitation for the Postsurgical Orthopaedic Patient’34 for the 4 week telerehabilitation intervention, as outlined in table 2. The website can be accessed at https://drmyco.ir/ and online supplemental file 1 contains instructions for navigating both the website and application, along with figures illustrating its features.

Supplemental material

Table 2

Description of content of virtual physiotherapy sessions for the intervention group

Control group (usual care)

The treatment process for the control group in this study, apart from receiving telerehabilitation services, is entirely similar to the intervention group. The treatment regimen for these individuals during the hospitalisation phase will be identical to the intervention group, following the usual treatment protocol prescribed by collaborating surgeons in the research. Physical therapy will not be prescribed in-person for patients until the 2 week postsurgery visit, consistent with the usual practice. If deemed necessary during the second-week postsurgery visit by the surgeon, patients will be referred to physical therapy centres for in-person therapy, and like the intervention group, these individuals will be excluded from the study.

Outcome measures

We will evaluate the impact of a 4 week telerehabilitation care programme on the following outcomes.

Primary outcomes

Feasibility

To measure the study’s feasibility, we will track recruitment and questionnaire completion rates. Adequate feasibility metrics for this study include 80% of interested individuals agreeing to screening, 60% of eligible individuals enrolling in the trial, baseline assessment completion rates above 80% and a final assessment completion rate above 70% at the end of the study.

Acceptability

To assess the acceptability of the study, participants will be assessed through a self-reporting online survey on the completion of the study period. Patient satisfaction and adherence to the intervention will be evaluated using a series of questions designed to assess satisfaction and adherence levels. The satisfaction questions will employ a 4-point Likert ordinal scale with four categories. The score will be calculated as the unweighted mean of the combined scores. Those questions have been adapted from the self-administered patient satisfaction scale for TKA.35 They have demonstrated validity and reliability as outcome measures for patient satisfaction following TKA in their original form.35 Additionally, five questions will be used to assess the level of adherence. The validity of these questions was assessed by six faculty members from AJA University of Medical Sciences who specialise in orthopaedic surgery and physiotherapy. The questions pertaining to the assessment of satisfaction and adherence levels are elaborated in online supplemental file 2. Additionally, participants will be asked about the challenges they encountered during the study, how they addressed them and any suggestions they have for improving the rehabilitation services. They will also be asked whether they would be willing to participate in the study again or recommend it to others (yes/no).

Supplemental material

The evaluative criteria for the study procedures and intervention will be deemed acceptable under the following conditions: an attrition rate of less than 20%, session attendance exceeding 80%, adherence to the intervention and satisfaction with the intervention achieving a score of 75 or higher and a minimum of 75% of participants expressing intent to partake in the study again or advocate its participation to others.

Secondary outcomes

Knee Injury and Osteoarthritis Outcome Score (KOOS) subscales

The KOOS subscales, encompassing ADLs, symptoms, pain and knee-related QoL, serve as patient-reported outcome measurements following TKA.36 37 These subscales, proven to be valid, reliable and responsive, will be assessed at both baseline and final evaluations. The ADLs subscale comprises 17 questions related to the patient’s function, while the symptoms and pain subscales consist of seven and nine questions, respectively. The knee-related QoL subscale includes four questions. Patients rate the difficulty experienced in the last week on a 5-point Likert scale, ranging from ‘none’ to ‘extreme’. Scores are calculated on a scale from 0 (best/no problems) to 100 (worst/extreme difficulties). We will utilise the Persian version of the KOOS questionnaire, for assessment of both groups, which has been approved for reliability and validity in Iran.38 The entire questionnaire, excluding the sport and recreation subscale, takes approximately 10 min to complete. The exclusion of the sport and recreation subscale at 4 weeks is due to the insufficient addressing or experience of most items within the first 4 weeks after surgery. It is noteworthy that a total score for the questionnaires has not been validated and is not recommended.36 These subscales will be measured at both the baseline and final assessments.

Patient global assessment

To evaluate the patient’s overall functional ability, a single numeric rating scale will be used at baseline, as recommended by Osteoarthritis Research Society International.39 The patients in both groups will be asked a single question regarding their current level of function during their usual ADLs: ‘How would you rate your current level of function during your usual ADLs?’ During the follow-up assessment, the same question will be asked. The response will be assessed using a visual rating scale, ranging from 0 to 100. The scale is anchored with ‘Inability to perform any daily activities’ (0) and ‘No problem with any daily activity’ (100) at the end.39 40

Walking assistant devices

The baseline and follow-up assessments will document the type and quantity of walking assistance devices (like a walker, or one or two crutches) used by the patients in both groups. The patient’s requirement for such devices will be determined based on the type and number of walking assistance devices they use during their routine daily activities.

Exercise adherence

This outcome will be assessed in both groups at the end of the study. Participants will be asked the following question: ‘During the past month after the surgery, on average, how many prescribed exercise sessions per day did you perform?’ The average number of exercise sessions per day will be calculated for each group and compared. The validity of this question was assessed by six faculty members from AJA University of Medical Sciences who specialise in orthopaedic surgery and physiotherapy.

Adverse events

In the final evaluation, which will take place at the end of the fourth-week postsurgery, both the control and intervention group patients will be asked the following question through an electronic questionnaire: ‘Have you required any reoperation or hospitalisation in the past month following the surgery? If the answer is positive, please specify the reason’. The responses from each group will be assessed and reported at the conclusion of the study. The validity of this inquiry was evaluated by six orthopaedic surgery and physiotherapy experts from AJA University of Medical Sciences.

Number of persons receiving in-person rehabilitation

The number of individuals receiving in-person physiotherapy services at the conclusion of the study will be calculated and compared between the two groups.

Participant timeline

The study schedule, including participant enrolment, interventions and assessments, is outlined in table 3 based on the SPIRIT template (33).

Table 3

Schedule for enrolment, interventions and assessment in this study

Sample size

The required sample size has been determined as 15 individuals per group based on previous studies.41 42 To evaluate the feasibility and acceptability of the intervention and clinical trial procedures, a sample of 30 participants will considered adequate.43 It is crucial to recognise that this study is essentially exploratory, not confirmatory. Therefore, secondary outcomes are not primarily concerned with statistical power, as the study refrains from drawing conclusions. Instead, it utilises descriptive statistics suitable for analysing pilot data to ascertain the accuracy of estimated means and variability.44–46

Recruitment

The eligibility of patients will be assessed following TKA at Atieh Hospital, and this process will continue until the desired target population is reached. Additionally, the physiotherapist interventionist will verify the patient’s potential eligibility. During the in-person visit, alongside providing usual care, the physiotherapist interventionist will confirm the patient’s eligibility, discuss further study details and encourage them to participate. To ensure patient engagement in the intervention, minimise attrition and enhance adherence to the intervention, we will utilise reminder messages. These reminders will be sent to both the patient and physiotherapist interventionist through Drmyco before each telerehabilitation session.

Randomisation and blinding

In this RCT, we will employ block randomisation47 to ensure the equitable allocation of participants to different treatment groups. Gender and the type of arthroplasty (unilateral or bilateral) will serve as stratification factors, and block-balanced randomisation with variable block sizes of four patients will be implemented. Participants will be randomised in a 1-to-1 ratio to either the intervention or usual care group. Due to the researcher’s awareness of the groupings, this study will be an open-label study. However, to minimise bias, the outcome assessor will act independently from the physiotherapist interventionist. Both the outcome assessor and statistician will be blinded and instructed not to inquire about whether the participants had received the intervention.

Data collection

The physiotherapist interventionist will collect demographic and clinical data from the patient’s medical records and through self-reported information. The feasibility of the study will be assessed based on recruitment and questionnaire completion rates. The evaluation process for the acceptability and secondary outcomes will involve designing the questionnaire items on an Iranian online platform which is a free online survey and form builder and can be accessed at https://survey.porsline.ir. The questionnaire links will be sent to patients via text messages. Patients will have the ability to access and respond to the questions by opening the text message and clicking on the provided link. The initial evaluation of secondary outcomes will be conducted before initiating the telerehabilitation intervention, on the day after discharge for both groups. For the final assessment, the same platform will be used after the 4 week postsurgery period. Once the mentioned questionnaires are completed by the patients, they will be collected, analysed and evaluated.

Data management

Data will be collected from assessment reports on the survey website (https://survey.porsline.ir). After completing data entry, a research team member not involved in the data management process will review the data for accuracy. Subsequently, an epidemiologist or statistician will be responsible for data cleaning and analysis.

Statistical methods

Continuous variables will be described using mean and SD (or median and IQR), while categorical variables will be presented with frequency (percentage) indices. The normality of the data will be assessed using the Shapiro-Wilk test. To compare continuous variables between groups, we will use the independent samples t-test (or Mann-Whitney test), and for within-group comparisons, the paired samples t-test (or Wilcoxon test, as appropriate). The association between two groups with demographic categorical characteristics will be analysed using the χ2 test or Fisher exact test, as appropriate. For univariate comparisons of postintervention outcomes, analysis of covariance will be employed, adjusting for baseline levels of the outcome of interest as a covariate. To assess the intervention’s effect on outcomes while accounting for confounding factors and baseline levels, multiple linear regression analysis will be conducted. All statistical tests will be performed using SPSS software V.16, and a significance level of less than 0.05 will be considered statistically significant.

Ethics approval and consent to participate

The Research Ethics Committee (REC) at AJAUMS reviewed and approved the study protocol, data collection forms, educational pamphlet and informed consent form template on 27 September 2023 (IR.AJAUMS.REC.1402.126). Eligible patients will receive an explanation of the intervention from both the orthopaedic surgeon and the physiotherapist interventionist to ensure informed consent. All participants will be asked to sign the written informed consent form, which has been prepared in accordance with the Declaration of Helsinki.48 Participants have the right to withdraw from the study at any time, with or without providing a reason. The physiotherapist interventionist will collect all personal information and secure it in locked filing cabinets and password-protected computer files accessible only to the study principal investigators. On eligible request, the corresponding author will provide information about the article. The participant consent form is provided in both Persian and English languages, available in online supplemental file 3.

Supplemental material

Discussion

TKA is a common surgical procedure aimed at alleviating pain and enhancing mobility in individuals with severe KOA.49 As the average age of the population in Iran is increasing, and the country is experiencing an ageing population,50 it is expected that a larger proportion of the population in future years will require TKA and similar procedures. However, many patients face challenges in attending in-person rehabilitation sessions due to transportation limitations and restricted access to rehabilitation facilities.32 Telerehabilitation offers a promising solution for delivering rehabilitation services to patients who are unable to physically attend sessions.51 Numerous studies have demonstrated the effectiveness of telerehabilitation after TKA in improving functional outcomes, reducing pain and increasing patient satisfaction.15 18 20 21 27 52 53 Moreover, telerehabilitation can alleviate the burden on healthcare facilities, expand the capacity of rehabilitation services and improve continuity of care.54 Nevertheless, it is crucial to tailor telerehabilitation services to the specific needs and preferences of patients and healthcare professionals.55 Despite advancements in telemedicine technologies, particularly after the COVID-19 pandemic, and the development and evaluation of necessary software and hardware infrastructure for remote patient rehabilitation in various countries,15 22 this area of treatment has not been thoroughly examined in Iran.56 According to our research, there is a lack of studies that have examined the feasibility of implementing this treatment approach following TKA in Iran. Therefore, it is crucial to investigate the feasibility of telerehabilitation following TKA in Iran. This feasibility study encompasses an evaluation of the technical and clinical aspects of telerehabilitation after TKA in Iran. We aim to develop a practical, culturally responsive intervention that can be applied to patients undergoing TKA in Iran and similar countries.

Trial status

The participant recruitment will commence in May 2024, with the anticipated intervention completion date for this study being July 2024.

Ethics statements

Patient consent for publication

This post was originally published on https://bmjopen.bmj.com