The Effect of Hybrid Tele-rehabilitation Versus In Person Rehabilitation on Pain and Function in Patients With Knee Osteoarthritis

Официальное название

The Effect of Hybrid Tele-rehabilitation Versus Standard Rehabilitation in Patients With Knee Osteoarthritis: A Single-blind Randomized Controlled Trial

Обзор

People with knee osteoarthritis often need regular physiotherapy sessions to reduce pain and improve movement. Attendance of in-person sessions can be difficult because of travel and time. This study aims to learn if combining in-person and video sessions using Zoom works for people with knee osteoarthritis. The main questions it aims to answer are : * Does combining in-person and video sessions improve pain and physical function in people with knee osteoarthritis? * Does combining in-person and video sessions improve adherence to the exercise program? * Are people satisfied with video sessions using Zoom? The researchers will compare the use of one in-person session and one video session per week to the standard care of two in-person sessions per week. Participants will : * Attend either (one in-person and one video session per week) or (two in-person sessions per week) for 8 weeks. * Perform exercise program that suits their needs during in-person and video sessions. * Record the number of attended sessions over 8 weeks. * Complete questionnaires about pain, physical function at the start and the end of the study. * Complete questionnaire about usability and satisfaction at the end of the study.

Вмешательства

• Другое Hybrid Tele-rehabilitation
  In-person session: participants attend the session in physiotherapy clinic.They will receive exercises (attached in the study protocol document) under the physiotherapist's supervision, including watching and correcting exercise techniques. Video session: participants attend video session via Zoom platform (Zoom Video Communications, inc., USA), an accessible internet-based platform from any laptop or mobile device that offers a real-time video and audio communications. Participants will receiv
• Другое Standard Rehabilitation
  In-person session: participants attend the session in physiotherapy clinic.They will receive exercises (attached in the study protocol document) under physiotherapist's supervision, including watching and correcting exercise techniques.

Первичные конечные точки

• Change in the pain intensity measured by Numeric pain rating scale [Срок оценки: Baseline and after 8 weeks of the intervention]
• Change in physical function measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [Срок оценки: Baseline and after 8 weeks of the intervention]
• Changes in lower limb strength measured by 30 seconds chair stand test [Срок оценки: Baseline and after 8 weeks of the intervention]

Вторичные конечные точки (2)

• Exercise adherence measured by weekly adherence log [Срок оценки: Weekly during 8 weeks of the intervention and at the end of the 8 weeks]
• Usability and satisfaction of Zoom based tele-rehabilitation measured by Tele-health Usability Questionnaire. [Срок оценки: After 8 weeks of the intervention]

Критерии участия

Критерии включения

• Mild to moderate knee osteoarthritis.
• Age 40 to 80 years old.
• Body Mass Index < 34 kg/m2.
• Numeric pain rating scale > 4 out of 10.
• Pain for more than 3 months.
• Morning stiffness lasting < 30 minutes (standard clinical criteria of knee osteoarthritis)
• Pain and crepitus with active motion (e.g., walking, sit to stand, stair climbing) (standard clinical criteria of knee osteoarthritis)
• Access to the device with an internet connection.
• Ability to use electronic devices or smart phones.

Критерии исключения

• Severe knee osteoarthritis and limited mobility or bonded to a wheelchair.
• Body Mass Index > 34 kg/m2
• On a waiting list for hip or knee surgery.
• Undergoing other forms of rehabilitation.
• Previous knee arthroplasty.
• Recent knee surgery within 6 months.
• Received cortisone injection within the previous 30 days.
• Rheumatoid arthritis, bilateral knee morning stiffness > 30 minutes.
• Unstable medical conditions.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Саудовская Аравия · 1 центр

• Department of Physical Therapy, Faculty of Medical Rehabilitation Sciences, King Abdulaziz — Jeddah

Публикации

• Hinman RS, Kimp AJ, Campbell PK, Russell T, Foster NE, Kasza J, Harris A, Bennell KL. Technology versus tradition: a non-inferiority trial comparing video to face-to-face consultations with a physiotherapist for people with knee osteoarthritis. Protocol for the PEAK randomised controlled trial. BMC Musculoskelet Disord. 2020 Aug 7;21(1):522. doi: 10.1186/s12891-020-03523-8. PMID 32767989

Идентификаторы

NCT: NCT06956222 · Tele-rehabilitation in OA

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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