Knee OsteoarthritisNCT06430242
Tele-rehabilitation in Knee Osteo Arthritis
A study testing Tele rehabilitation and Exercise in people with Knee Osteoarthritis, run by Prince Sattam Bin Abdulaziz University at 1 site in Saudi Arabia.
Trial summary
Osteoarthritis (OA) is the most common degenerative joint disease with an inflammatory component that starts from the matrix of the articular cartilage. Females are affected more than males and they have marked locomotor disabilities. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women only
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Tele rehabilitation and Exercise
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Oct 2023to 20 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 45 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with mild to moderate OA by their physicians.
- Female in the age range of 45 - 65 years.
- Volunteer to participate in the study.
- Living independently.
- Being able to walk without using an assistive device.
- Owning a mobile phone, tablet, or computer with an internet connection.
- Being able to use the device without assistance.
Who cannot join
- Having been diagnosed with any other systemic rheumatic diseases.
- Having been involved in a physiotherapy and rehabilitation program in any health institution in the last 6 months,
- Having knee-related surgery,
- Having meniscal or ligament-associated tears occurred in the past 6 months,
- Having a history of falling more than 2 times in the last 6 months,
- Having a history of knee injection in the last 4 weeks or scheduled in the next 8 week,
- Being illiterate, having cognitive problems, having blurred vision problem, and having hearing loss.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Tele-rehabilitation in Elderly Women With Locomotor Disabilities Due to Knee Osteo Arthritis
Osteoarthritis (OA) is the most common degenerative joint disease with an inflammatory component that starts from the matrix of the articular cartilage. Females are affected more than males and they have marked locomotor disabilities. Moreover, OA patients suffer from a range of extra-articular symptoms which also leads to functional impairment and disability such as fatigue, depression, anxiety, fear of movement, physical inactivity, and decreased muscle strength. OA management with physical therapy and exercise is recognized as the cornerstone of conservative and self-treatment for this chronic disease. The concept of telerehabilitation has been introduced in the field of physical medicine and rehabilitation, which combines telemedicine and rehabilitation interventions to support ongoing rehabilitation services for patients.
Read the detailed description
Osteoarthritis (OA) is the most common degenerative joint disease with an inflammatory component that starts from the matrix of the articular cartilage, progresses with disruption of chondrocyte responses and results in tissue destruction. In OA, primary involvement is seen in the articular cartilage, and progressive damage occurs. Females are affected more than males and they have marked locomotor disabilities. Moreover, OA patients suffer from a range of extra-articular symptoms which also leads to functional impairment and disability such as fatigue, depression, anxiety, fear of movement, physical inactivity, and decreased muscle strength.
OA management with physical therapy and exercise is recognized as the cornerstone of conservative and self-treatment for this chronic disease. The lack of professional supervision and feedback will result in reduced participation in continuing OA medical or rehabilitative services, which in turn will reduce the effectiveness of OA treatments.
With the development of telemedicine, it has been determined that patients living in remote areas have the chance to communicate with professional physicians simultaneously. The concept of telerehabilitation has been introduced in the field of physical medicine and rehabilitation, which combines telemedicine and rehabilitation interventions to support ongoing rehabilitation services for patients. Internet- based rehabilitation is one of the effective strategies in telerehabilitation. The use of the internet to provide health-related interventions has the potential to reduce the cost of treatment and improve user satisfaction.
- Conditions
- Knee Osteoarthritis
- Being tested
- Tele rehabilitation, Exercise
- Keywords
- Knee, Osteoarthritis, Locomotor, Disability, Female
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tele rehabilitationDevice
In the active group, one of the co-investigators will install and demonstrate the use of the mobile app (Rehab App) on participants' mobile phone and explain the use of the software. The participants will be followed up for the duration of their enrolment in the e-health and tele-rehabilitation service, which can last up to 2 months.
ExerciseOther
Participants in the control group will get the usual treatment from the clinical staff and in-person education, and they will be supervised by one of the assigned research team members every week.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | In the active group, one of the co-investigators will install and demonstrate the use of the mobile app (Rehab App) on participants' mobile phone and explain the use of the software. The participants will be followed up for the duration of their enrolment in the e-health and tele-rehabilitation service, which can last up to 2 months and the treatment will be monitored. Receives: Device: Tele rehabilitation |
| Group B | Active comparator | Participants in the control group will get the usual treatment from the clinical staff and in-person education, and they will be supervised by one of the assigned research team members every week. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Which was measured by 10 cm visual analogue scale
Measured: Baseline
Pain intensity
Which was measured by 10 cm visual analogue scale
Measured: 2 months
Pain intensity
Which was measured by 10 cm visual analogue scale
Measured: After 6 months
Secondary outcomes (15)
Functional disability
Which was measured by WOMAC questionnaire
Measured: Baseline
Functional disability
Which was measured by WOMAC questionnaire
Measured: 2 months
Functional disability
Which was measured by WOMAC questionnaire
Measured: 6 months
Gait velocity
Which was measured in meters/ second
Measured: Baseline
Gait velocity
Which was measured in meters/ second
Measured: 2 months
Gait velocity
Which was measured in meters/ second
Measured: 6 months
Step length
Which was measured in meters
Measured: Baseline
Step length
Which was measured in meters
Measured: 2 months
Step length
Which was measured in meters
Measured: 6 months
Cadence
Which was measured in number of steps per minute
Measured: Baseline
Cadence
Which was measured in number of steps per minute
Measured: 2 months
Cadence
Which was measured in number of steps per minute
Measured: 6 months
Quality
Which was measured with KOOS questionnaire
Measured: Baseline
Quality
Which was measured with KOOS questionnaire
Measured: 2 months
Quality
Which was measured with KOOS questionnaire
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2024
- Study start1 Oct 2023
- Primary completion20 Apr 2024
- Study completion20 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prince Sattam Bin Abdulaziz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gopal Nambi, Prince Sattam Bin Abdulaziz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06430242
- Sponsor's protocol ID
- RHPT-01
- Status last verified
- May 2024
- First submitted
- 28 Apr 2024
- Last updated
- 28 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Tele-rehabilitation in Elderly Women With Locomotor Disabilities Due to Knee Osteo Arthritis
- ClinicalTrials.gov ID
- NCT06430242
- Acronym / sponsor ID
- RHPT-01
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee, Osteoarthritis, Locomotor, Disability, Female
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Prince Sattam Bin Abdulaziz UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 20 Apr 2024 (actual)
- Study completion
- 20 Apr 2024 (actual)
- First posted
- 28 May 2024 (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.
Osteoarthritis (OA) is the most common degenerative joint disease with an inflammatory component that starts from the matrix of the articular cartilage. Females are affected more than males and they have marked locomotor disabilities. Moreover, OA patients suffer from a range of extra-articular symptoms which also leads to functional impairment and disability such as fatigue, depression, anxiety, fear of movement, physical inactivity, and decreased muscle strength. OA management with physical therapy and exercise is recognized as the cornerstone of conservative and self-treatment for this chronic disease. The concept of telerehabilitation has been introduced in the field of physical medicine and rehabilitation, which combines telemedicine and rehabilitation interventions to support ongoing rehabilitation services for patients.
Detailed description
Osteoarthritis (OA) is the most common degenerative joint disease with an inflammatory component that starts from the matrix of the articular cartilage, progresses with disruption of chondrocyte responses and results in tissue destruction. In OA, primary involvement is seen in the articular cartilage, and progressive damage occurs. Females are affected more than males and they have marked locomotor disabilities. Moreover, OA patients suffer from a range of extra-articular symptoms which also leads to functional impairment and disability such as fatigue, depression, anxiety, fear of movement, physical inactivity, and decreased muscle strength.
OA management with physical therapy and exercise is recognized as the cornerstone of conservative and self-treatment for this chronic disease. The lack of professional supervision and feedback will result in reduced participation in continuing OA medical or rehabilitative services, which in turn will reduce the effectiveness of OA treatments.
With the development of telemedicine, it has been determined that patients living in remote areas have the chance to communicate with professional physicians simultaneously. The concept of telerehabilitation has been introduced in the field of physical medicine and rehabilitation, which combines telemedicine and rehabilitation interventions to support ongoing rehabilitation services for patients. Internet- based rehabilitation is one of the effective strategies in telerehabilitation. The use of the internet to provide health-related interventions has the potential to reduce the cost of treatment and improve user satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Device: Tele rehabilitationIn the active group, one of the co-investigators will install and demonstrate the use of the mobile app (Rehab App) on participants' mobile phone and explain the use of the software. The participants will be followed up for the duration of their enrolment in the e-health and tele-rehabilitation service, which can last up to 2 months and the treatment will be monitored. |
| Group B | Active comparator | Other: ExerciseParticipants in the control group will get the usual treatment from the clinical staff and in-person education, and they will be supervised by one of the assigned research team members every week. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients diagnosed with mild to moderate OA by their physicians.
- Female in the age range of 45 - 65 years.
- Volunteer to participate in the study.
- Living independently.
- Being able to walk without using an assistive device.
Key exclusion criteria (7 listed)
- Having been diagnosed with any other systemic rheumatic diseases.
- Having been involved in a physiotherapy and rehabilitation program in any health institution in the last 6 months,
- Having knee-related surgery,
- Having meniscal or ligament-associated tears occurred in the past 6 months,
- Having a history of falling more than 2 times in the last 6 months,
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 |
|---|---|---|
| Tele rehabilitationIn the active group, one of the co-investigators will install and demonstrate the use of the mobile app (Rehab App) on participants' mobile phone and explain the use of the software. The participants will be followed up for the duration of their enrolment in the e-health and tele-rehabilitation service, which can last up to 2 months. | Device | Group A |
| ExerciseParticipants in the control group will get the usual treatment from the clinical staff and in-person education, and they will be supervised by one of the assigned research team members every week. | Other | Group B |
Primary outcome
Pain intensity
Time frame: Baseline
Which was measured by 10 cm visual analogue scale
Pain intensity
Time frame: 2 months
Which was measured by 10 cm visual analogue scale
Pain intensity
Time frame: After 6 months
Which was measured by 10 cm visual analogue scale
15 secondary outcomes
Functional disability
Time frame: Baseline
Functional disability
Time frame: 2 months
Functional disability
Time frame: 6 months
Gait velocity
Time frame: Baseline
Gait velocity
Time frame: 2 months
Gait velocity
Time frame: 6 months
Step length
Time frame: Baseline
Step length
Time frame: 2 months
Step length
Time frame: 6 months
Cadence
Time frame: Baseline
Cadence
Time frame: 2 months
Cadence
Time frame: 6 months
Quality
Time frame: Baseline
Quality
Time frame: 2 months
Quality
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2024.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tele rehabilitation and Exercise in people with Knee Osteoarthritis, run by Prince Sattam Bin 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 7 inclusion and 7 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: finished, as of the sponsor's last update on 28 May 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: Baseline). 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?
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 28 May 2024.