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OpenTrials
Completed

NCT Number: NCT06430242

Tele-rehabilitation in 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.

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Key information

Age range

45 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Gopal Nambi

Al Kharj, Riyadh Region, 11942, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tele rehabilitation

Device

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.

Exercise

Other

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.

Primary outcomes

  1. Pain intensity

    Time frame: Baseline

    Which was measured by 10 cm visual analogue scale

  2. Pain intensity

    Time frame: 2 months

    Which was measured by 10 cm visual analogue scale

  3. Pain intensity

    Time frame: After 6 months

    Which was measured by 10 cm visual analogue scale

Secondary outcomes

  1. Functional disability

    Time frame: Baseline

    Which was measured by WOMAC questionnaire

  2. Functional disability

    Time frame: 2 months

    Which was measured by WOMAC questionnaire

  3. Functional disability

    Time frame: 6 months

    Which was measured by WOMAC questionnaire

  4. Gait velocity

    Time frame: Baseline

    Which was measured in meters/ second

  5. Gait velocity

    Time frame: 2 months

    Which was measured in meters/ second

  6. Gait velocity

    Time frame: 6 months

    Which was measured in meters/ second

  7. Step length

    Time frame: Baseline

    Which was measured in meters

  8. Step length

    Time frame: 2 months

    Which was measured in meters

  9. Step length

    Time frame: 6 months

    Which was measured in meters

  10. Cadence

    Time frame: Baseline

    Which was measured in number of steps per minute

  11. Cadence

    Time frame: 2 months

    Which was measured in number of steps per minute

  12. Cadence

    Time frame: 6 months

    Which was measured in number of steps per minute

  13. Quality

    Time frame: Baseline

    Which was measured with KOOS questionnaire

  14. Quality

    Time frame: 2 months

    Which was measured with KOOS questionnaire

  15. Quality

    Time frame: 6 months

    Which was measured with KOOS questionnaire

Sponsors and collaborators

Lead sponsor

Prince Sattam Bin Abdulaziz University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 28, 2024
Registry last updated
May 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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