Clinical trial NCT06416332: Development and Testing of a Tele-rehabilitation System for Adult Patients With Knee Osteoarthritis
Official title: Development and Implementation of a Tele -Rehabilitation System for Patients With Knee Osteoarthritis (Aged 40-70 Years, Kellgren Grade 1-3 and Lawrence )
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis
Knee Osteoarthritis \(OA\)
Telerehabilitation
Keywords: Exercise
knee osteoarthitis
tele-rehabilitation
physical therapy
Lead sponsor: University of West Attica
Sponsor class: OTHER
First posted: 2024-05-16
Enrollment: 34
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment

This a randomized controlled trial with first primary end point at 8 weeks and second primary end point at 3 months. Participants will be allocated randomly into one of two intervention groups. Group1 (Telerehabilitation) Group 2 (in person)
Primary purpose: TREATMENT

Brief summary: DEVELOPMENT AND TESTING OF A TELEREHABILITION SYSTEM FOR PATIENTS WITH OSTEOARTHRITIS OF THE. KNEE (AGES 40-70 YEARS, GRADE 1-3, ACCORDING TO KELLGREN AND LAWRENCE) This study aims to develop and compare two methods of implementing a therapeutic exercise program for knee osteoarthritis: face-to-face sessions versus a telerehabilitation program. The telerehabilitation system will allow remote delivery of exercises with real-time monitoring and feedback. Measurement tools will assess various dimensions of knee osteoarthritis, ensuring comprehensive evaluation. Two experimental groups will receive either face-to-face or telerehabilitation sessions twice a week for eight weeks. Both groups will follow structured exercise programs, with the telerehabilitation group receiving remote instructions and feedback. Measurements will be taken before and after the intervention period, as well as at a three-month follow-up. Expected results include confirming and potentially enhancing findings regarding the effectiveness of remote rehabilitation for knee osteoarthritis. The study anticipates that telerehabilitation intervention could be equally or more effective than face-to-face intervention, ultimately providing a personalized, self-managed solution for managing chronic conditions like knee osteoarthritis.

Detailed description: 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.

The study will have two experimental groups , group A : face to face therapeutic exercise and group B: telerehabilitation program.

In group A: for face to face live therapeutic exercise the program and its progressivity will be determined and performed face to face according to the progress of the patient, with a frequency of sessions twice a week, session duration 45 minutes, following the recommended dosage of exercise according to clinical guidelines, while the total duration of the intervention will be eight weeks. You will be instructed to perform the program at home, 3 times a week. The standardized exercise program to be followed by this group will include :

1. Exercises to strengthen the hip and knee muscles through isometric contractions and resistance exercises using elastic bands.
2. Balance and neuromuscular coordination exercises. This standardized program will be structured following international guidelines and the gradual difficulty of the exercises will be confirmed through electromyographic activity of the respective muscle groups, following a pilot study, the results of which will be the mechanism for confirming the progression of the difficulty of each exercise, so that the patient can either proceed according to his progress to the next exercise, or return to a previous exercise if he experiences pain during its execution.

Initially, patients will be informed about the pathogenesis and the proposed, according to the article, management of the disease. Then, there will be a documentation and explanation of the progressive therapeutic exercise program, as suggested by the international literature, while printed material will also be distributed.

In group B: telerehabilitation program, the therapeutic exercise program will follow the same structure, which was mentioned above. The differentiation in the intervention of this group will be that the explanation of the exercises, their presentation, monitoring and information of the participants will be done through the telerehabilitation platform and special data processing software, as shown in diagram 1. The intervention time remains the same, with the physical therapist during these 45 minutes of the session , to evaluate the data on the patients progress by receiving the information through the software and to inform the patient of any changes in the progressivity of the exercise program. The other parameters of the intervention remain the same, as in the face to face live exercise.

All participants will initially complete a questionnaire that will include their history and demographics. They will complete the study questionnaires and submit to the respective tests, the same procedure will be followed after the eight weeks and the end of the respective interventions in both intervention groups and the same procedure will be followed after the three months.

The statistical processing will be done with SPSS (Statistical Package for the Social Science) software for Windows (version 25.0). A statistical analysis will be performed of the differences of each measurement, between the two interventions, as they will be recorded before the start of the intervention, eight weeks and three months later, using the MANOVA and Kruskal - Wallis test (for the non-parametric data). Data normality testing will be performed and the statistical significance level will be set at α = 0.05.

With the completion of this research work, it is expected to confirm and increase the findings of previous studies in the international literature regarding the effect of remote rehabilitation through an innovative telerehabilitation system, for patients suffering from knee osteoarthritis, through a series of assessment tools that do not have so far been described in combination. Evidence is awaited that telerehabilitation intervention will be equally - or even more - effective than in-person intervention. The ultimate and final goal will be to create an optimal, personalized environment for self-management of such a chronic pathological entity as knee osteoarthritis, with the perspective that this intervention will be the optimal solution for managing chronic diseases .

Eligibility criteria: Inclusion Criteria:

1. Age 40-70
2. Ability to provide consent and good knowledge of the Greek language
3. Diagnosed, radiographically and by an orthopedic doctor, knee osteoarthritis grade 1-3, according to Kellgren and Lawrence classification system of osteoarthritis
4. Diagnosis of knee osteoarthritis and good general health

Exclusion Criteria:

1. Participation in a systematic exercise program in the previous three months for the same problem
2. Participation in a physical therapy program in the previous three months for the same problem
3. Previous knee surgery within last three years
4. Medical contraindication to exercise
5. Systemic diseases or autoimmune in the acute phase of symptoms
6. Underlying severe neurological disease
7. Cognitive disability → inability to communicate
8. Red Flags (eg fractures (osteoporotic and non-osteoporotic), rapidly unexplained decrease in muscle strength, cardiorespiratory problems, etc.)

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Primary outcomes:
measure: pain and stiffness of the knee joint
timeFrame: [Time Frame: baseline, 8 weeks (end of treatment), 3 months (follow up)]
measure: the muscle performance of the quadriceps muscle
timeFrame: [Time Frame: baseline, 8 weeks (end of treatment), 3 months (follow up)]
Secondary outcomes:
measure: functionality
timeFrame: Time Frame: baseline, 8 weeks (end of treatment), 3 months (follow up)]
measure: Kinesiophobia
timeFrame: Time Frame: baseline, 8 weeks (end of treatment), 3 months (follow up)
measure: Balance - Propriety
timeFrame: Time Frame: baseline, 8 weeks (end of treatment), 3 months (follow up)]
measure: Anxiety - Depression
timeFrame: Time Frame: baseline, 8 weeks (end of treatment), 3 months (follow up)]
measure: Compliance
timeFrame: Time Frame: baseline, 8 weeks (end of treatment), 3 months (follow up)]
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Physiotherapy Department, University of West Attica
state: Agiou Spiridonos 28, 12243 Egaleo,
Study officials:
affiliation: uniwa
name: Theodora Plavoukou, PhDc
role: PRINCIPAL_INVESTIGATOR
affiliation: uniwa
name: George Georgoudis, PhD
role: STUDY_DIRECTOR
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