Tele-rehabilitation in Knee Osteo Arthritis

Knee Osteoarthritis Clinical Trial

Official title:

Role of Tele-rehabilitation in Elderly Women With Locomotor Disabilities Due to Knee Osteo Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06430242
• Other study ID #: RHPT-01
• Status: Completed
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: April 20, 2024

Study information

• Verified date: May 2024
• Source: Prince Sattam Bin Abdulaziz University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: April 20, 2024
• Est. primary completion date: April 20, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• Tele rehabilitation
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.

Other:
• Exercise
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.

Locations

Country	Name	City	State
Saudi Arabia	Gopal Nambi	Al Kharj	Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
Prince Sattam Bin Abdulaziz University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity	Which was measured by 10 cm visual analogue scale	Baseline
Primary	Pain intensity	Which was measured by 10 cm visual analogue scale	2 months
Primary	Pain intensity	Which was measured by 10 cm visual analogue scale	After 6 months
Secondary	Functional disability	Which was measured by WOMAC questionnaire	Baseline
Secondary	Functional disability	Which was measured by WOMAC questionnaire	2 months
Secondary	Functional disability	Which was measured by WOMAC questionnaire	6 months
Secondary	Gait velocity	Which was measured in meters/ second	Baseline
Secondary	Gait velocity	Which was measured in meters/ second	2 months
Secondary	Gait velocity	Which was measured in meters/ second	6 months
Secondary	Step length	Which was measured in meters	Baseline
Secondary	Step length	Which was measured in meters	2 months
Secondary	Step length	Which was measured in meters	6 months
Secondary	Cadence	Which was measured in number of steps per minute	Baseline
Secondary	Cadence	Which was measured in number of steps per minute	2 months
Secondary	Cadence	Which was measured in number of steps per minute	6 months
Secondary	Quality	Which was measured with KOOS questionnaire	Baseline
Secondary	Quality	Which was measured with KOOS questionnaire	2 months
Secondary	Quality	Which was measured with KOOS questionnaire	6 months