## Protocol Section
### Identification Module
**NCT ID:** NCT06420882

**Brief Title:** Comparison of Different Treatment Methods in Patella Chondromalacia

**Official Title:** Comparison of Different Treatment Methods in Patella Chondromalacia

#### Organization Study ID Info
**ID:** E-10840098-772.02-7994
#### Organization
**Class:** OTHER
**Full Name:** Istanbul Medipol University Hospital
### Status Module
#### Completion Date
**Date:** 2024-11-21

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-15

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-06-06

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-15

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-15
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Istanbul Medipol University Hospital

#### Responsible Party

**Investigator Affiliation:** Istanbul Medipol University Hospital

**Investigator Full Name:** gamze demircioglu

**Investigator Title:** Principal Investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Chondromalacia patella (CMP) is a common condition in patients presenting to healthcare units with anterior knee pain (1).

**Detailed Description:** Patellofemoral pain syndrome (PFPS) is the most common type of pain in runners with a prevalence of 17%; it is limited to the anterior knee or the area behind the patella between the edges of the patella. Although PFPS and CMP are often considered to be the same disease, there is still controversy about the subject. It is caused by decreased quadriceps muscle strength, change in mechanical loading, lower limb kinematics and differentiation in muscle activation patterns during running .

### Conditions Module

**Conditions:**

- Knee Injuries

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 50

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** rehabilitation group.

**Intervention Names:**

- Other: The rehabilitation group.

**Label:** The rehabilitation group.

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** The home exercise group

**Intervention Names:**

- Other: The home exercise group

**Label:** The home exercise group

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- The rehabilitation group.

**Description:** In the rehabilitation group, patella mobilisation, muscle strengthening exercises, range of motion exercises will be performed 3 days a week with a therapist for 3 sessions per week

**Name:** The rehabilitation group.

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- The home exercise group

**Description:** Participants in both groups will be included in a 3-week treatment programme.

**Name:** The home exercise group

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** The Turkish version of the WOMAC scale will be used to evaluate the pain, stiffness and physical function of the individuals included in the study. The score of each section is calculated within itself and the total score varies between 0 and 100. High scores indicate an increase in pain and stiffness and impairment in physical function (12,13).

**Measure:** WOMAC

**Time Frame:** 3 weeks

**Description:** Stair ascent and descent test: The patient's ascent and descent time of the 11-step staircase with a height of 14 cm and a depth of 29 cm were recorded separately with a stopwatch.

**Measure:** Stair climbing test

**Time Frame:** 3 weeks

**Description:** Knee joint range of motion will be measured with a goniometer.

**Measure:** Range of motion of the joint

**Time Frame:** 3 weeks

**Description:** The test is a simple but time-consuming test in terms of its application and is used to measure dynamic postural balance (1). The test is based on the ability to reach the farthest possible distance on the supporting leg with the free foot in 8 different directions

**Measure:** Star balance test

**Time Frame:** 3 weeks

**Description:** They jump to the farthest distance they can jump using their single and double legs and the best result obtained after at least 2 trials is recorded in cm. In this test, it should be noted that when contact with the ground after the jump, the measurement should be made at the heel level of the back foot, which is close to the starting line. Another point to be considered is that the participant should be stationary at the starting line. The participant cannot come to the line running and jump. But it is allowed to make a springing movement in front of the line

**Measure:** Horizontal jump test

**Time Frame:** 3 weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion criteria:

* 18-65 years of age.
* Being diagnosed with chondromalacia
* Participate in the work on a voluntary basis
* Obtaining informed consent from them

Exclusion criteria:

* Fracture, ligament or muscle tear in the lower extremity within the last 3 months.
* Having a systemic disease
* Having a serious injury in the last 3 months

**Maximum Age:** 25 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** gamzekantardemircioğlu@gmail.com

**Name:** gamze demircioğlu, PhD

**Phone:** 05348689544

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Istanbul

**Contacts:**

***Contact 1:***

- **Name:** gamze demircioğlu

- **Role:** CONTACT

**Country:** Turkey

**Facility:** Gamze Demircioğlu

**State:** None Selected

**Status:** RECRUITING

**Zip:** 34353

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007869

- Term: Leg Injuries

- ID: D000014947

- Term: Wounds and Injuries

- ID: D000009140

- Term: Musculoskeletal Diseases

- ID: D000003240

- Term: Connective Tissue Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC26

- Name: Wounds and Injuries

### Condition Browse Module - Browse Leaves

- ID: M25707

- Name: Chondromalacia Patellae

- Relevance: HIGH

- As Found: Patella Chondromalacia

- ID: M10738

- Name: Knee Injuries

- Relevance: HIGH

- As Found: Knee Injuries

- ID: M5611

- Name: Cartilage Diseases

- Relevance: HIGH

- As Found: Chondromalacia

- ID: M10881

- Name: Leg Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M17685

- Name: Wounds and Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6464

- Name: Connective Tissue Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000002357

- Term: Cartilage Diseases

- ID: D000046789

- Term: Chondromalacia Patellae

- ID: D000007718

- Term: Knee Injuries

### Misc Info Module

- Version Holder: 2024-05-31
