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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06956222
Enrollment
60
Registered
2025-05-04
Start date
2025-04-01
Completion date
2026-06-30
Last updated
2025-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis

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.

Interventions

OTHERHybrid 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 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.

OTHERStandard 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.

Sponsors

King Abdulaziz University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

The outcome assessor will be blinded to the group allocation

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.

Eligibility

Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in the pain intensity measured by Numeric pain rating scaleBaseline and after 8 weeks of the interventionThe Numeric pain rating scale assesses the pain intensity using 11 points scale, where 0 indicates no pain and 10 indicates the worst pain
Change in physical function measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)Baseline and after 8 weeks of the interventionThe 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
Changes in lower limb strength measured by 30 seconds chair stand testBaseline and after 8 weeks of the interventionThe 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

MeasureTime frameDescription
Exercise adherence measured by weekly adherence logWeekly during 8 weeks of the intervention and at the end of the 8 weeksThe 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.
Usability and satisfaction of Zoom based tele-rehabilitation measured by Tele-health Usability Questionnaire.After 8 weeks of the interventionThe 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

Countries

Saudi Arabia

Contacts

Primary ContactAnfal Astek
aastek@kau.edu.sa+966555668075

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026