Clinical trial NCT06956222: The Effect of Hybrid Tele-rehabilitation Versus In Person Rehabilitation on Pain and Function in Patients With Knee Osteoarthritis
Official title: The Effect of Hybrid Tele-rehabilitation Versus Standard Rehabilitation in Patients With Knee Osteoarthritis: A Single-blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: King Abdulaziz University
Sponsor class: OTHER
First posted: 2025-05-04
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Arm 1(hybrid tele-rehabilitation): Participants will receive in-person and video sessions of prescribed exercises.

Arm 2 (standard rehabilitation): Participants will receive in-person sessions alone of prescribed exercises.
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in the pain intensity measured by Numeric pain rating scale
timeFrame: Baseline and after 8 weeks of the intervention
measure: Change in physical function measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: Baseline and after 8 weeks of the intervention
measure: Changes in lower limb strength measured by 30 seconds chair stand test
timeFrame: Baseline and after 8 weeks of the intervention
Secondary outcomes:
measure: Exercise adherence measured by weekly adherence log
timeFrame: Weekly during 8 weeks of the intervention and at the end of the 8 weeks
measure: Usability and satisfaction of Zoom based tele-rehabilitation measured by Tele-health Usability Questionnaire.
timeFrame: After 8 weeks of the intervention
Other outcomes:
Locations:
city: Jeddah
country: Saudi Arabia
facility: Department of Physical Therapy, Faculty of Medical Rehabilitation Sciences, King Abdulaziz University
Study officials:
affiliation: Department of Physical Therapy, Faculty of Medical Rehabilitation Sciences, King Abdulaziz University, Jeddah, Saudi Arabia
name: Anfal Astek
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.