Development and Testing of a Tele-rehabilitation System for Adult Patients With Knee Osteoarthritis
NCT ID: NCT06416332
Last Updated: 2024-05-16
Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
NA
34 participants
INTERVENTIONAL
2022-09-13
2024-12-31
Brief Summary
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Detailed Description
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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 .
Conditions
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Study Design
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RANDOMIZED
PARALLEL
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)
TREATMENT
DOUBLE
Study Groups
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in face to face live group
In the live therapeutic exercise group (group A) the program and its progression will be determined and performed for life according to the patient's progress, with a frequency of sessions twice a week, a session duration of 45 minutes, following the recommended dosage of exercise according to with the clinical instructions, while the total duration of the intervention will be eight weeks.
group A: in face to face live therapeutic exercise
In group A: in face to face live therapeutic exercise the program and its progressivity will be determined and performed for life 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.
telerehabilitation program group
In the telerehabilitation program group (group B), the therapeutic exercise program will follow the same structure, with differences in the explanation of the exercises, their presentation, as well as the monitoring and information of the participants, as they will be done through a telerehabilitation platform and a special software data processing. The intervention time remains the same, with the physiotherapist in these 45 minutes of the session evaluating the data on the patient's progress by receiving the information through the software, and informing the patient of any changes in the progression of the exercise program. The remaining parameters of the intervention also remain the same, as in face to face live exercise.
group B: telerehabilitation program
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. 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 person exercise.
Interventions
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group A: in face to face live therapeutic exercise
In group A: in face to face live therapeutic exercise the program and its progressivity will be determined and performed for life 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.
group B: telerehabilitation program
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. 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 person exercise.
Eligibility Criteria
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Inclusion Criteria
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
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.)
\-
40 Years
70 Years
ALL
No
Sponsors
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University of West Attica
OTHER
Responsible Party
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Theodora Plavoukou
PT,MSc,PhD(can)Physiotherapy Department of the University West Attica
Principal Investigators
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Theodora Plavoukou, PhDc
Role: PRINCIPAL_INVESTIGATOR
uniwa
George Georgoudis, PhD
Role: STUDY_DIRECTOR
uniwa
Locations
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Physiotherapy Department, University of West Attica
Athens, Agiou Spiridonos 28, 12243 Egaleo,, Greece
Countries
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References
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Skrepnik N, Spitzer A, Altman R, Hoekstra J, Stewart J, Toselli R. Assessing the Impact of a Novel Smartphone Application Compared With Standard Follow-Up on Mobility of Patients With Knee Osteoarthritis Following Treatment With Hylan G-F 20: A Randomized Controlled Trial. JMIR Mhealth Uhealth. 2017 May 9;5(5):e64. doi: 10.2196/mhealth.7179.
Saki, F., Bakhtiari Khou, S. and Ramezan, F. (2020). The Role of Digital Technologies as an Alternative for Face-to-Face Knee Rehabilitation: A Systematic Review. Physical Treatments: Specific Physical Therapy Journal, 10(4), pp.185-194
Naeemabadi, Mr., Fazlali, H., Najafi, S., Dinesen, B. and Hansen, J. (2020). Telerehabilitation for Patients With Knee Osteoarthritis: A Focused Review of Technologies and Teleservices. JMIR Biomedical Engineering, 5(1), p.e16991.
Mecklenburg G, Smittenaar P, Erhart-Hledik JC, Perez DA, Hunter S. Effects of a 12-Week Digital Care Program for Chronic Knee Pain on Pain, Mobility, and Surgery Risk: Randomized Controlled Trial. J Med Internet Res. 2018 Apr 25;20(4):e156. doi: 10.2196/jmir.9667.
Kolasinski SL, Neogi T, Hochberg MC, Oatis C, Guyatt G, Block J, Callahan L, Copenhaver C, Dodge C, Felson D, Gellar K, Harvey WF, Hawker G, Herzig E, Kwoh CK, Nelson AE, Samuels J, Scanzello C, White D, Wise B, Altman RD, DiRenzo D, Fontanarosa J, Giradi G, Ishimori M, Misra D, Shah AA, Shmagel AK, Thoma LM, Turgunbaev M, Turner AS, Reston J. 2019 American College of Rheumatology/Arthritis Foundation Guideline for the Management of Osteoarthritis of the Hand, Hip, and Knee. Arthritis Rheumatol. 2020 Feb;72(2):220-233. doi: 10.1002/art.41142. Epub 2020 Jan 6.
Johnson AJ, Palit S, Terry EL, Thompson OJ, Powell-Roach K, Dyal BW, Ansell M, Booker SQ. Managing osteoarthritis pain with smart technology: a narrative review. Rheumatol Adv Pract. 2021 Mar 16;5(1):rkab021. doi: 10.1093/rap/rkab021. eCollection 2021.
Byra J, Czernicki K. The Effectiveness of Virtual Reality Rehabilitation in Patients with Knee and Hip Osteoarthritis. J Clin Med. 2020 Aug 14;9(8):2639. doi: 10.3390/jcm9082639.
Bennell K, Nelligan RK, Schwartz S, Kasza J, Kimp A, Crofts SJ, Hinman RS. Behavior Change Text Messages for Home Exercise Adherence in Knee Osteoarthritis: Randomized Trial. J Med Internet Res. 2020 Sep 28;22(9):e21749. doi: 10.2196/21749.
Allen KD, Arbeeva L, Callahan LF, Golightly YM, Goode AP, Heiderscheit BC, Huffman KM, Severson HH, Schwartz TA. Physical therapy vs internet-based exercise training for patients with knee osteoarthritis: results of a randomized controlled trial. Osteoarthritis Cartilage. 2018 Mar;26(3):383-396. doi: 10.1016/j.joca.2017.12.008. Epub 2018 Jan 5.
Other Identifiers
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61123-27/06/2023
Identifier Type: -
Identifier Source: org_study_id
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