Knee OsteoarthritisNCT06956222
The Effect of Hybrid Tele-rehabilitation Versus In Person Rehabilitation on Pain and Function in Patients With Knee Osteoarthritis
A study testing Hybrid Tele-rehabilitation and Standard Rehabilitation in people with Knee Osteoarthritis, run by King Abdulaziz University at 1 site in Saudi Arabia.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Hybrid Tele-rehabilitation and Standard Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Apr 2025to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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.
Who cannot join
- 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.
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- Received cortisone injection within the previous 30 days.
- Rheumatoid arthritis, bilateral knee morning stiffness > 30 minutes.
- Unstable medical conditions.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Saudi Arabia1 site, 1 recruiting
- Recruiting
Department of Physical Therapy, Faculty of Medical Rehabilitation Sciences, King Abdulaziz University
Jeddah, 21589
Hajed Al-Otiabi, +966126967474, hotaibi1@kau.edu.sa
Anfal Astek
About this study
Official title: The Effect of Hybrid Tele-rehabilitation Versus Standard Rehabilitation in Patients With Knee Osteoarthritis: A Single-blind Randomized Controlled Trial
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?
Read more
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.
- Conditions
- Knee Osteoarthritis
- Being tested
- Hybrid Tele-rehabilitation, Standard Rehabilitation
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hybrid Tele-rehabilitationOther
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 RehabilitationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Hybrid Tele-rehabilitation | Experimental | participants will receive one in-person and one video session per week for 8 weeks. Both sessions include the same exercise program delivered by a physiotherapist. Receives: Other: Hybrid Tele-rehabilitation |
| Standard Rehabilitation | Active comparator | participants will receive two in-person sessions per week for 8 weeks. All sessions include an exercise program delivered by a physiotherapist. Receives: Other: Standard Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the pain intensity measured by Numeric pain rating scale
The Numeric pain rating scale assesses the pain intensity using 11 points scale, where 0 indicates no pain and 10 indicates the worst pain
Measured: Baseline and after 8 weeks of the intervention
Change in physical function measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
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
Measured: Baseline and after 8 weeks of the intervention
Changes in lower limb strength measured by 30 seconds chair stand test
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.
Measured: Baseline and after 8 weeks of the intervention
Secondary outcomes (2)
Exercise adherence measured by weekly adherence log
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.
Measured: 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.
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
Measured: After 8 weeks of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2025
- Study start1 Apr 2025
- Primary completionDec 2025 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Abdulaziz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anfal Adnan Astek, King Abdulaziz University
- Investigators
- Anfal Astek, Principal investigator, Department of Physical Therapy, Faculty of Medical Rehabilitation Sciences, King Abdulaziz University, Jeddah, Saudi Arabia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06956222
- Sponsor's protocol ID
- Tele-rehabilitation in OA
- Status last verified
- Apr 2025
- First submitted
- 19 Apr 2025
- Last updated
- 4 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data will be shared, including: Pain intensity scores (Numeric Pain Rating Scale), Functional scores (WOMAC function subscale, 30-Second Chair Stand Test), Exercise adherence log and Usability scores from the Telehealth Usability Questionnaire (TUQ)
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.
PubMed 32767989
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Hybrid Tele-rehabilitation Versus Standard Rehabilitation in Patients With Knee Osteoarthritis: A Single-blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06956222
- Acronym / sponsor ID
- Tele-rehabilitation in OA
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- King Abdulaziz UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 4 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Hybrid Tele-rehabilitation | Experimental | Other: Hybrid Tele-rehabilitationparticipants will receive one in-person and one video session per week for 8 weeks. Both sessions include the same exercise program delivered by a physiotherapist. |
| Standard Rehabilitation | Active comparator | Other: Standard Rehabilitationparticipants will receive two in-person sessions per week for 8 weeks. All sessions include an exercise program delivered by a physiotherapist. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hybrid Tele-rehabilitationIn-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. | Other | Hybrid Tele-rehabilitation |
| Standard RehabilitationIn-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. | Other | Standard Rehabilitation |
Primary outcome
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
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
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.
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2025.
- Background: PubMed 32767989Hinman 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.
- Individual participant dataSharing planned: Yes. De-identified individual participant data will be shared, including: Pain intensity scores (Numeric Pain Rating Scale), Functional scores (WOMAC function subscale, 30-Second Chair Stand Test), Exercise adherence log and Usability scores from the Telehealth Usability Questionnaire (TUQ)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anfal Astek principal investigator
Department of Physical Therapy, Faculty of Medical Rehabilitation Sciences, King Abdulaziz University, Jeddah, Saudi Arabia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hybrid Tele-rehabilitation and Standard Rehabilitation in people with Knee Osteoarthritis, run by King Abdulaziz University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anfal Astek (+966555668075, aastek@kau.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the pain intensity measured by Numeric pain rating scale (time frame: Baseline and after 8 weeks of the intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06956222, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2025.