Development and Implementation of a Tele -Rehabilitation System for Patients With Knee Osteoarthritis (Aged 40-70 Years, Kellgren Grade 1-3 and Lawrence )

The purpose of this study is to develop, investigate and compare the effectiveness of a new system of remote therapeutic exercise, using technological equipment, in relation to face to face therapeutic exercise, which is proposed by international guidelines, in patients with osteoarthritis of the knee. More specifically, the magnitude of the improvement of motor, kinematic and psychocognitive parameters, physical condition, functionality, quality of life and symptoms of the disease will be examined, using these two methods. It is fully understood and constitutes one of the objectives of this study , that the volume of this information should be transmitted to the patient and the physical therapist in the most understandable and simplified way possible. Finally, the effectiveness of the interventions will also be evaluated in relation to the ease of use and execution of the therapeutic exercise plan, as well as the degree of compliance of the patients with each intervention method.

The aim of the present study is the development of an innovative telerehabilitation system and the comparison of two different methods of implementation of a therapeutic exercise program for knee osteoarthritis, and in particular a face to face live program and a remote application program. In order to implement remote intervention, a rehabilitation system for patients with knee osteoarthritis will be created, where therapeutic exercise will be provided through special software and technological equipment and the patients progress will be monitored remotely or in real time, whenever this is deemed necessary. . In this way, it is expected to create a remote but immediate rehabilitation environment, with easy access, which will provide flexibility, short response time and economy during its application by the patient.

This study is a multicenter, single-blind, randomized, controlled prospective study with two parallel axes will be designed. The sample will come from the places where the study will be carried out and which are legal physical therapy laboratories.The participants of this study will be volunteers a considedered a sample of men and women, aged 40-70 years with radiographically and orthopedically diagnosed knee osteoarthritis, Kellgren grade 1-3 and Lawrence classification system of osteoarthritis.

The Sample size was determined by the G- power test analysis based on the primary outcome measures selected and the effect size size which is reported in similar studies. According to a meta-analysis, the effect size for pain measures ( whether the measurements were made using questionnaires or algometers ) was equal to SMD =0.66, in all the measurement tools used . Finally, in a research, in which the isokinetic dynamometer was used as a measuring tool, the effect size for the strength of the subjects quadriceps muscle was equal to SMD =0.42. Thus, taking into account all the above and setting the level of statistical significance at α=0.05 and the power of the study at 80%, through the G- power analysis test the sample size was determined at 34 participants. Assuming a potential loss to follow-up of 20% of participants, the minimum sample size was calculated at 42 patients.

The randomization process will be performed by an independent researcher. The allocation of participants will be done randomly through the use of the random.org program. Sealed envelopes will be given to participants prior to their allocation to research groups and each envelope will indicate the group to which each participant is allocated, as randomly assigned by the computer program.