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NCT Number: NCT06956222

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

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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Physical Therapy, Faculty of Medical Rehabilitation Sciences, King Abdulaziz University

Jeddah, 21589, Saudi Arabia

Location status: Recruiting

Location contact

Anfal Astek

PRINCIPAL_INVESTIGATOR

Hajed Al-Otiabi

CONTACT

[email protected]

+966126967474

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hybrid Tele-rehabilitation

Other

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 receive a Zoom link with a unique password. During the video session, the physiotherapist accesses from the clinic using a laptop, while participants are based at their home. Participants will receive exercises (attached in the study protocol document) with real time instructions from the physiotherapist. Instructions on downloading and accessing Zoom platform will be given to the participants in the first in-person session to ensure their readiness to access the Zoom platform.

Standard Rehabilitation

Other

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.

Primary outcomes

  1. Change in the pain intensity measured by Numeric pain rating scale

    Time frame: Baseline and after 8 weeks of the intervention

    The Numeric pain rating scale assesses the pain intensity using 11 points scale, where 0 indicates no pain and 10 indicates the worst pain

  2. Change in physical function measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    Time frame: Baseline and after 8 weeks of the intervention

    The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), a validated self reported questionnaire designed to assess the physical function of individuals with knee osteoarthritis. it consists of 17 items rated on a 5-points Likert scale ( 0=none, 4=extreme). Scores range from 0 to 68, in which higher scores indicate worse physical function

  3. Changes in lower limb strength measured by 30 seconds chair stand test

    Time frame: Baseline and after 8 weeks of the intervention

    The 30 seconds chair stand test assesses the lower limb strength and functional performance. The participant will be asked to stand straight and return to sitting on a standard high chair as many times as possible within 30 seconds without using their arms. The total number of completed full stand will be recorded and a higher number indicates better lower limb strength and function.

Secondary outcomes

  1. Exercise adherence measured by weekly adherence log

    Time frame: Weekly during 8 weeks of the intervention and at the end of the 8 weeks

    The weekly adherence log will be completed by the physical therapist to assess the participants adherence to either in person or zoom sessions. Adherence will be calculated as the number of calculated sessions over 8 weeks (2 sessions per week, 16 sessions). A higher number indicates better adherence to the exercise program.

  2. Usability and satisfaction of Zoom based tele-rehabilitation measured by Tele-health Usability Questionnaire.

    Time frame: After 8 weeks of the intervention

    The Telehealth Usability Questionnaire (TUQ) is a validated patient-reported questionnaire to evaluate the usability of tele health services across six domains: usefulness, ease of use, interface quality, interaction quality, reliability, and satisfaction. It includes 21 items rated on a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree). The higher scores indicate greater usability and satisfaction with Zoom tele-rehabilitation

Study contacts

Contact information is provided by the study sponsor or research team.

Anfal Astek

CONTACT

[email protected]

+966555668075

Sponsors and collaborators

Lead sponsor

King Abdulaziz University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
May 4, 2025
Registry last updated
May 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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