## Protocol Section
### Identification Module
**NCT ID:** NCT06430242

**Brief Title:** Tele-rehabilitation in Knee Osteo Arthritis

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

#### Organization Study ID Info
**ID:** RHPT-01
#### Organization
**Class:** OTHER
**Full Name:** Prince Sattam Bin Abdulaziz University
### Status Module
#### Completion Date
**Date:** 2024-04-20

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-23

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2024-04-20

**Type:** ACTUAL

#### Start Date
**Date:** 2023-10-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-28
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Prince Sattam Bin Abdulaziz University

#### Responsible Party

**Investigator Affiliation:** Prince Sattam Bin Abdulaziz University

**Investigator Full Name:** Gopal Nambi

**Investigator Title:** Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

**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.

### Conditions Module

**Conditions:**

- Knee Osteoarthritis

**Keywords:**

- Knee

- Osteoarthritis

- Locomotor

- Disability

- Female

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 56

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Device: Tele rehabilitation

**Label:** Group A

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 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.

**Intervention Names:**

- Other: Exercise

**Label:** Group B

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Group A

**Description:** 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.

**Name:** Tele rehabilitation

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- Group B

**Description:** 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.

**Name:** Exercise

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Which was measured by 10 cm visual analogue scale

**Measure:** Pain intensity

**Time Frame:** Baseline

**Description:** Which was measured by 10 cm visual analogue scale

**Measure:** Pain intensity

**Time Frame:** 2 months

**Description:** Which was measured by 10 cm visual analogue scale

**Measure:** Pain intensity

**Time Frame:** After 6 months

#### Secondary Outcomes

**Description:** Which was measured by WOMAC questionnaire

**Measure:** Functional disability

**Time Frame:** Baseline

**Description:** Which was measured by WOMAC questionnaire

**Measure:** Functional disability

**Time Frame:** 2 months

**Description:** Which was measured by WOMAC questionnaire

**Measure:** Functional disability

**Time Frame:** 6 months

**Description:** Which was measured in meters/ second

**Measure:** Gait velocity

**Time Frame:** Baseline

**Description:** Which was measured in meters/ second

**Measure:** Gait velocity

**Time Frame:** 2 months

**Description:** Which was measured in meters/ second

**Measure:** Gait velocity

**Time Frame:** 6 months

**Description:** Which was measured in meters

**Measure:** Step length

**Time Frame:** Baseline

**Description:** Which was measured in meters

**Measure:** Step length

**Time Frame:** 2 months

**Description:** Which was measured in meters

**Measure:** Step length

**Time Frame:** 6 months

**Description:** Which was measured in number of steps per minute

**Measure:** Cadence

**Time Frame:** Baseline

**Description:** Which was measured in number of steps per minute

**Measure:** Cadence

**Time Frame:** 2 months

**Description:** Which was measured in number of steps per minute

**Measure:** Cadence

**Time Frame:** 6 months

**Description:** Which was measured with KOOS questionnaire

**Measure:** Quality

**Time Frame:** Baseline

**Description:** Which was measured with KOOS questionnaire

**Measure:** Quality

**Time Frame:** 2 months

**Description:** Which was measured with KOOS questionnaire

**Measure:** Quality

**Time Frame:** 6 months

### Eligibility Module

**Eligibility Criteria:** 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.

**Gender Based:** True

**Gender Description:** Female participants in the age range of 45 - 65 years.

**Maximum Age:** 65 Years

**Minimum Age:** 45 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Al Kharj

**Country:** Saudi Arabia

**Facility:** Gopal Nambi

**State:** Riyadh

**Zip:** 11942

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001168

- Term: Arthritis

- ID: D000007592

- Term: Joint Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

- ID: D000012216

- Term: Rheumatic Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

### Condition Browse Module - Browse Leaves

- ID: M12926

- Name: Osteoarthritis

- Relevance: HIGH

- As Found: Osteo Arthritis

- ID: M22168

- Name: Osteoarthritis, Knee

- Relevance: HIGH

- As Found: Knee Osteo Arthritis

- ID: M4476

- Name: Arthritis

- Relevance: LOW

- As Found: Unknown

- ID: M10621

- Name: Joint Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15045

- Name: Rheumatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6323

- Name: Collagen Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000010003

- Term: Osteoarthritis

- ID: D000020370

- Term: Osteoarthritis, Knee

### Misc Info Module

- Version Holder: 2024-05-31
