Evaluation of Safety and Efficacy of ReHub in Patients Who Underwent Primary Total Knee Arthroplasty: Study Protocol for a Randomized Controlled Trial PROTOCOL MONTSE NUEVO SIMONE BALOCCO HADIS MAHDAVI MARCO CONTI DANIEL RODRÍGUEZ ALESSANDRO CASTAGNA TERESA FAURA SALVI PRAT NÚRIA FABRELLAS *Author affiliations can be found in the back matter of this article ABSTRACT CORRESPONDING AUTHOR: Montse Nuevo, PT, MSc Background: Total Knee Arthroplasty (TKA) is an intervention that can significantly Clinic Institute of Medical and improve the quality of life of patients with advanced knee osteoarthritis. Early start Surgical Specialties (ICEMEQ), of rehabilitation and its continuation at home once the patient is discharged are key Hospital Clínic of Barcelona, factors for the success of the process. C.Villarroel 170. 08036, Barcelona, Spain; Nursing This study aims to assess the effectiveness of a home-based telerehabilitation solution and Health Sciences (PhD (ReHub) on improving functional capacity and clinical outcomes for patients who programme), University of underwent TKA. Barcelona, Faculty of Medicine and Health Sciences, Bellvitge Methods/design: The study is a randomized, open-label with blinded outcome assessor, Health Sciences Campus, parallel assignment clinical trial with a sample size of 52 patients that is conducted according C.Feixa Llarga s/n, L´Hospitalet to the SPIRIT recommendations. After the TKA intervention, the patients are randomly de Llobregat, 08907, Barcelona, Spain allocated to the control group or the experimental group with a 1:1 ratio. Both groups follow mnuevo@clinic.cat a Fast Track recovery protocol which includes discharge after 2–3 days from surgery, a daily plan of 5 exercises for autonomous rehabilitation and domiciliary visits by a physiotherapist starting approximately 2 weeks after surgery. The experimental group uses the sensor-based KEYWORDS: telerehabilitation system ReHub to perform the exercises. The primary outcome measure is home rehabilitation; the range of motion of the knee. Secondary outcomes include physical performance, quality telerehabilitation; physical of life, pain intensity, muscle strength, treatment adherence and satisfaction with the ReHub therapy; total knee system. The outcomes assessment is performed at hospital discharge (baseline), at stitch arthroplasty; digital health removal (2 weeks after baseline) and 2 weeks after stitch removal (4 weeks after baseline). TO CITE THIS ARTICLE: Nuevo M, Mahdavi H, Rodríguez The study conforms to the guidelines of the Declaration of Helsinki and was approved D, Faura T, Fabrellas N, Balocco by the hospital’s ethics committee. S, Conti M, Castagna A, Prat S. 2021. Evaluation of Safety and Discussion: The study will address an important gap in the evidence base by reporting Efficacy of ReHub in Patients the effectiveness of an affordable and low-cost home-based telerehabilitation solution Who Underwent Primary Total in patients who underwent TKA. Knee Arthroplasty: Study Protocol for a Randomized Ethics and dissemination: The study was approved by the hospital’s ethics committee Controlled Trial. International (“Comité Ético de Investigación Clínica del HCB”, reg. HCB/2019/0571). The trial was Journal of Surgery: Protocols, registred at ClinicalTrials.gov (NCT04155957). The results of this study will be published 25(1), pp. 34–41. DOI: https:// in peer-reviewed journals as well as national and international conferences. doi.org/10.29337/ijsp.138 Nuevo et al. International Journal of Surgery: Protocols DOI: 10.29337/ijsp.138 35 Trial registration: NCT04155957 (ClinicalTrials.gov). Highlights: • Assessing a home-based telerehabilitation solution effectiveness in knee surgery. • In situations such as the CoVid-19 pandemic, it is a resolutive intervention method. • Telerehabilitation is an alternative to conventional face-to-face physical therapy. • This system is far less demanding in terms of human resources. • Range of motion assessment is the primary outcome measure. BACKGROUND Recently Correia et al. [12] demonstrated that home telerehabilitation after TKA is feasible, engaging, and Knee osteoarthritis (KO) is the most common joint capable of maximizing clinical outcomes in comparison to condition and causes significant amounts of disability conventional rehabilitation in the short and medium-term worldwide [1]. Total Knee Arthroplasty (TKA) is an and is far less demanding in terms of human resources. intervention which has improved the quality of life According to other recent studies, telerehabilitation of the patients with advanced knee osteoarthritis. shows a positive impact on patient compliance and In recent years, “Rapid Recovery” or “Fast-Track” adherence [9, 11, 13], which is a really important factor strategies, have been developed and applied in TKA for a better functional recovery after TKA surgery. We and other selective operations. These strategies aim to must not forget the role of these innovative technologies enhance post-operative recovery and reduce morbidity, in empowering the patient and promoting their active functional convalescence and hospital stay lengths and participation in their recovery process, a vital aspect in costs [2–3]. Pre-operative rehabilitation and patient achieving maximum success in early and late functional empowerment, as well as the early start of post- outcomes [14]. It is also important to consider the operative rehabilitation once the patient is discharged, patient’s opinion on the matter. There is strong evidence are key factors for the success of the recovery process to support the use of virtual systems to increase patient after a TKA [4–5]. satisfaction in patients who have undergone TKA [15]. Patients with TKA operated at some hospitals in Spain This trial contributes to the scientific knowledge base systematically undergo a specific training program a few regarding the effects of telerehabilitation. weeks before surgery. They familiarize themselves with We hypothesized that a home-based telerehabilitation the surgical process and the physical exercises they shall program performed through the remote supervision perform before and immediately after the surgery. This of the patient’s performance and adherence can allows for a better recovery and decreases the stress of improve clinical outcomes compared to conventional surgery [6]. After hospital discharge (usually between (unsupervised) home-based rehabilitation. 48h to 72h after surgery), patients continue the exercise Therefore, the overall objective of this study is to program at home as they have been taught. However, the evaluate the effectiveness of a new telerehabilitation adherence of the patients to this program is unknown. solution, ReHub, for the improvement of physical To monitor patients’ activities, health professionals can function and clinical outcomes following TKA. ReHub is only rely on the information provided by the patients an interactive telerehabilitation system developed by themselves and/or their families. Approximately 2 weeks DyCare which delivers personalized home rehabilitation after the surgery, patients start receiving visits from a for Muscle-Skeletal Disorder (MSD) sufferers. physiotherapist at home. Domiciliary rehabilitation is estimated to take 10 sessions distributed in 2 or 3 days per week, depending on the availability. METHODS On the other hand, telerehabilitation has been STUDY DESIGN AND RANDOMIZATION rapidly expanding as an alternative or a complement The study is a prospective, randomized, controlled, to conventional face-to-face physical therapy since its parallel-group, open-label with blinded assessor trial that development [7]. Telerehabilitation systems monitor the is conducted according to the SPIRIT recommendations patients with sensors and software, allowing the therapist [16]. Following informed consent, patients are to intervene in the rehabilitation progress remotely. The randomized (with a 1:1 allocation ratio) to a control patient feels monitored, motivated and supported [8]. group or an experimental group. Computer-generated Besides, comparable results are obtained to conventional randomization lists are used (using the website www. outpatient physical therapy [9–10], or even face-to-face randomization.com) to sequentially distribute the physical therapy with home rehabilitation [11], and are patients into one of the two groups. The primary outcome widely accepted by patients [9–10]. measure is knee Range of Motion (ROM). Nuevo et al. International Journal of Surgery: Protocols DOI: 10.29337/ijsp.138 36 Patients are evaluated with inclusion/exclusion criteria Patients sign informed consent 1:1 Randomisation (n=52) Remote monitoring rehabilitation group Conventional rehabilitation group (n=26) (n=26) Exercise at home by ReHub+home Exercise at home without physiotherapy monitoring+home physiotherapy Safety and effectiveness evaluation Figure 1 REHAPT flow diagram. The study conforms to the guidelines of the INCLUSION CRITERIA: Declaration of Helsinki, was approved by the hospital’s 1. Age of the candidates shall be between 18 and 75 years ethics committee (“Comité Ético de Investigación Clínica 2. Ability to understand and accept the study procedures and del HCB”, reg. HCB/2019/0571), and registered at the to sign an informed consent form 3. Good predisposition to the use of technology or availability ClinicalTrials.gov website (identifier NCT04155957). of a caregiver providing technological support to the patient A flow diagram of the study design is shown in Figure 1. 4. Availability to move to the hospital for visits 5. The patient resides in the hospital’s area of influence PARTICIPANTS/RANDOMIZATION/ EXCLUSION CRITERIA: ALLOCATION/BLINDING Any type of disability that could alter the homogeneity of the The general outline of this open-label, parallel- study leads to exclusion as well as sensory and/or cognitive assignment, controlled clinical trial with blinded impairment or concomitant medical conditions which may evaluators is the following: candidates to a TKA with affect the rehabilitation process. In addition, major medical complications occurring after surgery (e.g. surgical wound no interfering comorbidities and between 18 and 75 infection, suspicious of deep vein thrombosis) also lead to years old will need to sign an Informed Consent Form exclusion. to be enrolled in the study. The patients then will be randomized with an allocation ratio of 1:1 into one of the Table 1 Inclusion and Exclusion criteria. two groups: the Control group, receiving the traditional home rehabilitation that patients who undergo Total considering the following inclusion and exclusion criteria Knee Arthroplasty (TKA) in a third level hospital (Rapid mentioned in Table 1. Recovery Program), or the Experimental group, following The expected recruitment rate is 2 patients per week. the same rehabilitation plan for TKA with ReHub instead of usual autonomous rehabilitation exercices. INTERVENTIONS Following the allocation of the groups, trained blinded Patients are normally discharged 48 hours after the nurses will complete all functional assessments and operation with an updated physiotherapy schedule and collect all clinical data on the Case Report Form for each a leaflet containing the exercises and patterns to follow. patient. These evaluations will be made at the time of The physiotherapist makes sure that the patients (from discharge from hospital, after two weeks and after four both groups) have understood them and will perform weeks, both during the follow-up visits. them correctly. A total of 52 patients will be recruited following The rehabilitation program duration per patient is 4 a personal interview carried out by the investigators weeks (30 days) after hospital discharge. Three visits take Nuevo et al. International Journal of Surgery: Protocols DOI: 10.29337/ijsp.138 37 place, one at discharge (baseline), another after 2 weeks company, 2–3 days per week, up to 10 sessions. The and the final visit after 4 weeks (Table 2). details of the intervention for each group are as follows: The following outcome measures are collected for the patients at the visits: • Experimental Group: A site team physiotherapist will make three home • Active Knee ROM (°) with a goniometer, both flexion visits during the 4 weeks. In the first visit (the day and extension after discharge), the patient receives a ReHub bag • Passive Knee ROM (°) with a goniometer, both flexion including a tablet with ReHub installed and the and extension Exercise Kit. The site team physiotherapist explains • Timed Get-Up-and-Go test (s) how ReHub works and how to perform exercises. • Quadriceps muscle strength with a dynamometer (kg) The second visit (second day after discharge) is a • Hamstring muscle strength with a dynamometer (kg) follow-up visit to ensure the correct use of ReHub • Pain Level with a Visual Analog Scale (VAS) so the patient can perform his/her exercises • Western Ontario and McMaster Universities properly. An optional third visit can be planned for Osteoarthritis Index (WOMAC) the following day at this stage if the patient has • EuroQol-5D-5L score difficulties using the platform. The patient follows • Adherence to exercise program (only collected in last the exercise program with ReHub, and a site team visit) physiotherapist monitors the patient’s progress • System Usability Scale (only collected in last visit for daily through the platform. experimental patients) 12–17 days after surgery, the patient attends the hospital for stitch removal and the second visit Both groups shall perform at home the prescribed takes place. If required, in this visit the therapy is exercises. The control group will follow the common reprogrammed. The day after the second visit, a site home rehabilitation recommendations and exercise team physiotherapist makes the last home visit to autonomously while the experimental group patients ensure no problems have arisen during the last 2 weeks. will use ReHub to perform their exercises; for both groups Around 30 days after the surgery, patients attend the exercise pattern will be the same. the hospital for the final control. In addition to In addition, and as part of the usual hospital protocol, the aforementioned outcome measures, patient during the last two weeks, the participants of both groups satisfaction with ReHub is measured by the will receive a visit from a physiotherapist from an external administration of the System Usability Scale as well. RECRUITMENT BASELINE INTERVENTION FOLLOW- INTERVENTION FINAL VISIT (2 WEEKS) UP VISIT (2 WEEKS) VISIT TIMEPOINT -to t0 t1 t2 Screening & Eligibility X Informed consent procedure X Treatment randomization X ReHub training (Experimental Arm only) X Timed Up-and-Go X X X Knee ROM X X X Muscle strength X X X Pain level (VAS) X X X WOMAC X X X EuroQol-5D-5L X X X Patient diary data collection (Control X Arm only) System Usability Scale (Experimental X Arm only) Adherence X Adverse events X X Table 2 Timepoint chart. Nuevo et al. International Journal of Surgery: Protocols DOI: 10.29337/ijsp.138 38 • Control Group: 4. WOMAC – EuroQoL-5D-5L The 3 main visits are the same as the experimental WOMAC (Western Ontario and McMaster Universities group and the same outcomes are measured. The Osteoarthritis Index) [21, 22] and EuroQoL-5D-5L [23] control group does not receive home visits from are standard questionnaires which are self-administered the site team physiotherapists. Patients are asked by the patients and will be compared with the baseline to fill out a diary to indicate which exercises they later in the analysis to explore the improvements in the performed and the corresponding dates. At the quality of life of the patients in both groups of the study. final visit at the hospital, in addition to collecting the aforementioned outcome measures, the 5. Adherence patients’ exercise diary will be collected. The adherence to the home exercise program is measured by obtaining the percentage of exercises done from the ReHub database for the experimental group OUTCOME MEASURES and from the exercise diary filled by control patients in Primary outcomes the control group. 1. ROM Active and Passive All ROM tests are conducted using a manual, plastic, 2-group 6. Satisfaction and Safety of the ReHub System goniometer with 1-degree increments. The goniometer is The experimental patients’ satisfaction with ReHub is centred on the knee joint. The distal reference marker is measured with the results of the System Usability Scale the peroneal malleolus and the proximal reference point (SUS) [24]. The questionnaire is also self-administered. is the greater trochanter in the hip [17]. To make sure The Physiotherapist-Patient interaction for the that the goniometer is centred on the knee axis point, the experimental group is also measured through the patient is asked to bend and extend the knee a couple of number of messages exchanged between them within times. This axis point should not change in the flexion and ReHub’s chat feature. extension movement. For the measurement of the active The safety of the system will be evaluated with flexion ROM, the patient is sitting in a chair and is asked the rate of adverse events reported during the study. to bend the knee as much as possible. For passive flexion Examples of adverse events are minor cutaneous injuries, ROM, the assistant helps the patient to bend until the indentations on soft body parts and software failures. patient indicates that it is the maximum point. For the active extension ROM, the patient is lying in REHUB TELEREHABILITATION SYSTEM the supine position on a bed and is asked to stretch the ReHub is a digital platform for physical rehabilitation that knee as far as possible. For passive extension ROM, the offers personalized design and monitoring of therapeutic assistant helps the patient to stretch until the patient exercise programs to recover the functional capacity of says it is the maximum point. the musculoskeletal system. The solution is composed of two main pillars; a Secondary outcomes cloud platform and an exercise kit that includes an 1. Timed Up-and-Go inertial motion sensor. The cloud platform establishes The Timed Up-and-Go (TUG) test measures the time communication between the patient and the healthcare required for standing up from a chair, walking straight for professionals in charge of their rehabilitation. It allows 3 meters, turning, walking back to the chair, and sitting physical therapists to create a rehabilitation program down [18]. The nurse is in charge of indicating when to specifically tailored to each patient’s condition. A start the test. dashboard allows the professional to follow the progress of the patient, see the results of the exercises performed 2. Muscle strength and adapt the program remotely. The maximal isometric voluntary contraction of the Patients use the cloud platform to perform the operated leg is assessed using a handheld dynamometer exercises in their rehabilitation program with the help (Lafayette Manual Muscle Tester) [19]. The muscle of DyCare’s proprietary wearable sensor that captures strength test of the knee extension is performed for the 3D motion data. The sensor is integrated into different quadriceps and then the knee flexion test is performed exercise tools that help the patient performing different for the hamstrings. Knee extension is assessed with the kinds of exercises make up the rest of the kit, though participants in sitting position with their feet on the floor only a body strap is used in this trial as the exercises and with the hip at 90° of flexion. in the rehabilitation program designed by the hospital do not require additional tools. The sensor records 3. VAS biomechanical parameters such as range of motion and To assess the pain level, the patient is asked to rate the speed in real-time when used on the indicated body pain he/she feels on a Visual Analog Scale that ranges part while exercising. When patients do their prescribed from 0 to 10, with 0 being «no pain» and 10 being the exercises at home, intelligent algorithms deliver real- “worst pain imaginable” [20]. time biofeedback through a User Interface and a Virtual Nuevo et al. International Journal of Surgery: Protocols DOI: 10.29337/ijsp.138 39 Coach. The results can be viewed by the physiotherapist the effectiveness of a home-based telerehabilitation to follow the progress of the patient, adapt the program program for physical function and/or muscle strength remotely if needed or chat with them with the online improvement following TKA could have relevant messaging module through the platform. implications for the post-surgical rehabilitation process. In fact, telerehabilitation solutions could facilitate access SAMPLE SIZE ESTIMATION AND STATISTICAL and adherence to health interventions, reduce health ANALYSIS care costs (associated with supervision, facility provision, Sample size estimation was performed considering active and transport of patients), and also contribute to social knee flexion Range of Motion as the outcome measure. distancing when it becomes necessary as an infection Considering a power of 80%, a two-sided significance control action. In addition, the results of the study level of 0.05 and a dropout rate of 10%, to detect a 10° could support the systematic incorporation of solutions difference between the two groups, a sample size of 52 like ReHub in post-surgical rehabilitation protocols, that patients will be needed. A standard deviation of 12° was should be tailored to the individual and collective needs. determined by previous clinical trials [25, 26]. The statistical analysis over the results will be performed by a blinded expert. Within and between- TRIAL STATUS group comparisons will be performed by Two-sample t-test or one-way and two-way ANOVA analysis. The first study participants were recruited into the trial in Data will be expressed as mean ± standard deviation December 2019. The study was planned to end by April (normally distributed data) or median and interquartile 2020, but recruitment was heavily altered due to the range (non-normally distributed data). The threshold for COVID-19 pandemic situation in Spain. Patient recruitment statistical significance will be set to P = 0.05. Missing data and data collection are ongoing and will continue until the will be treated with the Last Observation Carried Forward required number of study participants is achieved. method. All statistical tests will be performed with Matlab (The MathWorks, Inc., Natick, Massachusetts, United States) DATA ACCESSIBILITY STATEMENT software package. Data will be made available upon request to the corresponding author due to privacy or other restrictions. DISCUSSION This study aims to assess the effectiveness of a home- ETHICS AND CONSENT based telerehabilitation program for the improvement of physical function and clinical outcome following TKA. Participants (or the substitute decision-makers) have In addition, patient satisfaction with the telerehabilitation the procedures explained and provide written informed solution (ReHub) is evaluated to explore whether it consent. The study is conducted in accordance with the increases the adherence to the treatment among other Declaration of Helsinki and was approved by the hospital’s improvements. Another important point of the study will ethics committee (“Comité Ético de Investigación Clínica be the evaluation of the costs of the rehabilitation process del HCB”, reg. HCB/2019/0571). with the ReHub program compared to conventional rehabilitation and as a result, the economic effects it can have, particularly for the public health system. ACKNOWLEDGEMENTS The randomized controlled design, blinding of the individual performing the outcome assessments, and use This study is partially supported by European Union’s of valid tools for the assessment of physical performance H2020-SME Instrument programme under grant and muscle strength (TUG score and dynamometer- agreement No 811755. The granting body is not involved based measurements of muscle strength under isometric in data collection or analysis. conditions, respectively) are notable strengths of the study. However, the short duration of the intervention (4 weeks) and the lack of a long-term follow-up that could help FUNDING INFORMATION determine with more precision whether telerehabilitation could have lasting benefits could be a limitation to our This study is supported by the EU within the Horizon 2020 study. Also, the fact that the adherence of control patients Framework Programme (“Rehabilitation Hub: The World’s to their exercise program is self-reported in an exercise first Digital Recovery Therapy solution”, grant agreement diary, could affect the evaluation of this parameter. ID: 811755). The funders had no role in the design of the Notwithstanding these limitations, demonstrating study or in writing the manuscript. Nuevo et al. International Journal of Surgery: Protocols DOI: 10.29337/ijsp.138 40 COMPETING INTERESTS Alessandro Castagna orcid.org/0000-0002-2029-3539 Humanitas Clinical and Research Center, IRCSS, Rozzano (Mi), Italy; Humanitas University, Department of Biomedical MC and AC have a shareholder position at Bio-Sensing Sciences, Pieve Emanuele (Mi), Italy Solutions S.L. Salvi Prat orcid.org/0000-0002-2122-0614 DR and HM are employees of Bio-Sensing Solutions S.L. Clinic Institute of Medical and Surgical Specialties (ICEMEQ), but do not have shareholder positions. SB is a member of Knee Unit. Hospital Clínic of Barcelona, C.Villarroel 170, 08036, the scientific advisory board in Bio-Sensing Solutions S.L. Barcelona, Spain; Medicine School, Campus Casanova, University The rest of the authors declare no competing interest. of Barcelona, C.Casanova, 143, 08036, Barcelona, Spain AUTHOR CONTRIBUTIONS REFERENCES MN and SP are responsible for the daily operational 1. Murray CJL, Vos T, Lozano R, et al. Disability-adjusted life aspects of the study. MN, HM and DR wrote the first years (DALYs) for 291 diseases and injuries in 21 regions, drafts of the manuscript. All authors took part in the 1990–2010 : a systematic analysis for the Global Burden design of the study, participated in the preparation of the of Disease Study 2010. Lancet. 2012; 380: 2197–223. DOI: manuscript, and approved its final version. https://doi.org/10.1016/S0140-6736(12)61689-4 2. Pujol O, García B, Faura T, et al. 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