Tele-rehabilitation in Knee Osteo Arthritis

NCT06430242 | Completed

• 1 other identifier: RHPT-01
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Knee Osteoarthritis

Keywords

Knee; Osteoarthritis; Locomotor; Disability; Female

Outcome Measures

Primary Outcomes (3)

• Pain intensity

  Which was measured by 10 cm visual analogue scale

  Baseline

• Pain intensity

  Which was measured by 10 cm visual analogue scale

  2 months

• Pain intensity

  Which was measured by 10 cm visual analogue scale

  After 6 months

Secondary Outcomes (15)

• Functional disability

  Baseline

• Functional disability

  2 months

• Functional disability

  6 months

• Gait velocity

  Baseline

• Gait velocity

  2 months

Study Arms (2)

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.

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.

Other: Exercise

Interventions

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.

Group A

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.

Group B

Eligibility Criteria

• Age: 45 Years - 65 Years
• Gender Eligibility Details: Female participants in the age range of 45 - 65 years.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Prince Sattam Bin Abdulaziz University: lead

Study Sites (1)

Gopal Nambi

Al Kharj, Riyadh Region, 11942, Saudi Arabia

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Interventions

Telerehabilitation; Exercise

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 28, 2024
• First Posted: May 28, 2024
• Study Start: October 1, 2023
• Primary Completion: April 20, 2024
• Study Completion: April 20, 2024
• Last Updated: May 28, 2024

Record last verified: 2024-05

Locations

SA (1)