Tele-rehabilitation in Knee Osteo Arthritis

May 23, 2024 updated by: Gopal Nambi, Prince Sattam Bin Abdulaziz University

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.

Study Overview

Status

Completed

Conditions

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

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Riyadh
      • Al Kharj, Riyadh, Saudi Arabia, 11942
        • Gopal Nambi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2023

Primary Completion (Actual)

April 20, 2024

Study Completion (Actual)

April 20, 2024

Study Registration Dates

First Submitted

April 28, 2024

First Submitted That Met QC Criteria

May 23, 2024

First Posted (Actual)

May 28, 2024

Study Record Updates

Last Update Posted (Actual)

May 28, 2024

Last Update Submitted That Met QC Criteria

May 23, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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