- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06430242
Tele-rehabilitation in Knee Osteo Arthritis
Role of Tele-rehabilitation in Elderly Women With Locomotor Disabilities Due to Knee Osteo Arthritis
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Riyadh
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Al Kharj, Riyadh, Saudi Arabia, 11942
- Gopal Nambi
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group A
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.
|
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.
|
|
Active Comparator: Group B
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain intensity
Time Frame: Baseline
|
Which was measured by 10 cm visual analogue scale
|
Baseline
|
|
Pain intensity
Time Frame: 2 months
|
Which was measured by 10 cm visual analogue scale
|
2 months
|
|
Pain intensity
Time Frame: After 6 months
|
Which was measured by 10 cm visual analogue scale
|
After 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functional disability
Time Frame: Baseline
|
Which was measured by WOMAC questionnaire
|
Baseline
|
|
Functional disability
Time Frame: 2 months
|
Which was measured by WOMAC questionnaire
|
2 months
|
|
Functional disability
Time Frame: 6 months
|
Which was measured by WOMAC questionnaire
|
6 months
|
|
Gait velocity
Time Frame: Baseline
|
Which was measured in meters/ second
|
Baseline
|
|
Gait velocity
Time Frame: 2 months
|
Which was measured in meters/ second
|
2 months
|
|
Gait velocity
Time Frame: 6 months
|
Which was measured in meters/ second
|
6 months
|
|
Step length
Time Frame: Baseline
|
Which was measured in meters
|
Baseline
|
|
Step length
Time Frame: 2 months
|
Which was measured in meters
|
2 months
|
|
Step length
Time Frame: 6 months
|
Which was measured in meters
|
6 months
|
|
Cadence
Time Frame: Baseline
|
Which was measured in number of steps per minute
|
Baseline
|
|
Cadence
Time Frame: 2 months
|
Which was measured in number of steps per minute
|
2 months
|
|
Cadence
Time Frame: 6 months
|
Which was measured in number of steps per minute
|
6 months
|
|
Quality
Time Frame: Baseline
|
Which was measured with KOOS questionnaire
|
Baseline
|
|
Quality
Time Frame: 2 months
|
Which was measured with KOOS questionnaire
|
2 months
|
|
Quality
Time Frame: 6 months
|
Which was measured with KOOS questionnaire
|
6 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RHPT-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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