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Recruiting NCT06956222

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

No phase Interventional Knee Osteoarthritis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Hybrid Tele-rehabilitation, Standard Rehabilitation.
Who it may be relevant to
Registry conditions: Knee Osteoarthritis. Basic parameters: 40 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Saudi Arabia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Other 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
  • Other 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.

Primary outcome measures

  • Change in the pain intensity measured by Numeric pain rating scale [Time frame: Baseline and after 8 weeks of the intervention]
  • 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]
  • Changes in lower limb strength measured by 30 seconds chair stand test [Time frame: Baseline and after 8 weeks of the intervention]
Secondary outcome measures (2)
  • Exercise adherence measured by weekly adherence log [Time frame: 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. [Time frame: After 8 weeks of the intervention]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Saudi Arabia · 1 center
  • Department of Physical Therapy, Faculty of Medical Rehabilitation Sciences, King Abdulaziz — Jeddah

Publications

  • 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

Identifiers

NCT: NCT06956222 · Tele-rehabilitation in OA

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗