Development and Testing of a Tele-rehabilitation System for Adult Patients With Knee Osteoarthritis

NCT06416332 | Active Not Recruiting DMC

• 1 other identifier: 61123-27/06/2023
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis; Knee Osteoarthritis \(OA\); Telerehabilitation

Keywords

Exercise; knee osteoarthitis; tele-rehabilitation; physical therapy

Outcome Measures

Primary Outcomes (2)

• pain and stiffness of the knee joint

  "change" is being assessed for pain and stiffness of the knee joint with The WOMAC tool (Western Ontario and McMasters Universities Osteoarthritis Index), is a widely used measure. The questionnaire consists of 24 sections which are divided into three subscales . A five-point Likert (0-4) isosceles scale is used for calibration . Thus the pain subscale can be scored from 0-20, the stiffness 0-8 and the functionality 0-68. In addition to the Linkert scale, the VAS scale (visual analog scale) can be used. On a straight line of 10 cm, from 0 (no pain) to 10 (worst pain), the patient notes the pain he is experiencing at that moment. The WOMAC questionnaire is reliable and valid, the Greek version has been checked for its validity and reliability in a research.

  [Time Frame: baseline, 8 weeks (end of treatment), 3 months (follow up)]

• the muscle performance of the quadriceps muscle

  "change" is being assessed for the muscle perfomance done with the help of the surface electromyogram with and the use of an isokinetic dynamometer, which are also considered as the gold standard standard .

  [Time Frame: baseline, 8 weeks (end of treatment), 3 months (follow up)]

Secondary Outcomes (5)

• functionality

  Time Frame: baseline, 8 weeks (end of treatment), 3 months (follow up)]

• Kinesiophobia

  Time Frame: baseline, 8 weeks (end of treatment), 3 months (follow up)

• Balance - Propriety

  Time Frame: baseline, 8 weeks (end of treatment), 3 months (follow up)]

• Anxiety - Depression

  Time Frame: baseline, 8 weeks (end of treatment), 3 months (follow up)]

• Compliance

  Time Frame: baseline, 8 weeks (end of treatment), 3 months (follow up)]

Study Arms (2)

in face to face live group

EXPERIMENTAL

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.

Other: group A: in face to face live therapeutic exercise

telerehabilitation program group

EXPERIMENTAL

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.

Other: group B: telerehabilitation program

Interventions

group A: in face to face live therapeutic exercise OTHER

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.

in face to face live group

group B: telerehabilitation program OTHER

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.

telerehabilitation program group

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of West Attica: lead

Study Sites (1)

Physiotherapy Department, University of West Attica

Athens, Agiou Spiridonos 28, 12243 Egaleo,, 12243, Greece

Location

Related Publications (10)

• 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.

  PMID: 28487266 BACKGROUND

• 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

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 29695370 BACKGROUND

• 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.

  PMID: 31908163 BACKGROUND

• 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.

  PMID: 33928214 BACKGROUND

• 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.

  PMID: 32823832 BACKGROUND

• 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.

  PMID: 32985994 BACKGROUND

• 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.

  PMID: 29307722 BACKGROUND

• Plavoukou T, Kasnesis P, Contiero Syropoulou A, Papagiannis G, Stasinopoulos D, Georgoudis G. A Sensor-Augmented Telerehabilitation System for Knee Osteoarthritis: A Randomized Controlled Trial of Neuromuscular, Functional, and Psychosocial Outcomes. Sensors (Basel). 2025 Nov 21;25(23):7113. doi: 10.3390/s25237113.

  PMID: 41374487 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Motor Activity

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Behavior

Study Officials

• Theodora Plavoukou, PhDc

  uniwa

  PRINCIPAL INVESTIGATOR

• George Georgoudis, PhD

  uniwa

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The Investigator and outcomes assessor are blinded to patient allocation and data code.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PT,MSc,PhD(can)Physiotherapy Department of the University West Attica

Model Details: 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)

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: May 16, 2024
• Study Start: September 13, 2022
• Primary Completion: September 1, 2024
• Study Completion: December 1, 2024
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: 6 months after publication date and only upon agreement by the authors that there will be no further changes and/or analysis may data be shared.
• Access Criteria: It is to the authors discretion to share study data to other researchers.

Locations

GR (1)