## Protocol Section
### Identification Module
**NCT ID:** NCT06433167

**Brief Title:** Investigation of Gait Pattern in Idiopathic Scoliosis

**Official Title:** Investigation of Gait Pattern in Idiopathic Scoliosis

#### Organization Study ID Info
**ID:** Iayas9
#### Organization
**Class:** OTHER
**Full Name:** Gazi University
### Status Module
#### Completion Date
**Date:** 2025-01-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-26

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-12-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-15

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-18
**Study First Submit QC Date:** 2024-05-26
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Gazi University

#### Responsible Party

**Investigator Affiliation:** Gazi University

**Investigator Full Name:** İnci Hazal Ayas

**Investigator Title:** Research asistant

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Scoliosis is a condition characterized by an abnormal curvature of the spine, which can affect an individual's gait. Scoliosis can alter body balance and weight distribution. Pedobarographic analysis identifies imbalances and abnormal pressure points by measuring the distribution of pressure applied to the sole of the foot. This examination helps detect abnormalities in the gait mechanics of individuals with scoliosis. Gait analysis can identify long-term foot and leg problems caused by scoliosis at an early stage, allowing for early interventions to prevent more serious issues.

The aim of this study is to analyze gait in individuals with idiopathic scoliosis and compare it with that of healthy individuals. The study will include 30 scoliosis patients who visited the Department of Orthopedics and Traumatology at Gazi University Hospital and were diagnosed with idiopathic scoliosis by a specialist physician. The gait patterns of the patients will be evaluated using pedobarography. Information about the type and degree of scoliosis will be obtained from hospital records. The results of this study may provide an objective and detailed evaluation of gait and pressure distribution disorders in individuals with scoliosis and may contribute to more effective treatment plans.

### Conditions Module

**Conditions:**

- Idiopathic Scoliosis

### Design Module

#### Design Info

**Observational Model:** CASE_CONTROL

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 30

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** The patient group for this research comprises patients diagnosed with idiopathic scoliosis, a condition characterized by abnormal lateral curvature of the spine of unknown cause.

**Intervention Names:**

- Other: Pedobarographic analysis

**Label:** Idiopathic Scoliosis

#### Arm Group 2

**Description:** Healthy control group is healthy individuals without any diagnosed disease.

**Intervention Names:**

- Other: Pedobarographic analysis

**Label:** Healthy control

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Healthy control

- Idiopathic Scoliosis

**Description:** During the pedobarographic analysis, the patient takes steps on the platform at a regular walking speed, with arms relaxed at the sides, following a natural gait. In static analysis, measurements are taken while the patient remains stationary on the platform with arms in a relaxed position beside the body. Five measurements are separately recorded for both feet during the phases of stepping, heel strike, and toe lift. These measurements capture the highest pressures on the back of the foot, the middle part of the foot, and the inner, middle, and lateral sides of the front of the foot, including the toes. The pressure, force, and pressure-time integral corresponding to each area are then used to determine how and for how long these areas are exposed to pressure.

**Name:** Pedobarographic analysis

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** This assessment uses a specialized device called a pedobarograph, which consists of pressure sensors embedded in a platform. When a person stands or walks on the pedobarograph, the sensors record the pressure exerted by different parts of the foot. The resulting data is then used to create detailed pressure maps and graphs that highlight areas of high and low pressure.

**Measure:** Pedobarography

**Time Frame:** Day 1

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Diagnosis of idiopathic scoliosis by an orthopedist
* The Cobb angle measured on the standard scoliosis radiograph should fall within the range of 10°-45°.

Exclusion Criteria:

* Presence of any orthopedic or neurological disease affecting trunk and extremity mobility, excluding scoliosis.
* History of previous spine or orthopedic surgery.

**Healthy Volunteers:** True

**Maximum Age:** 65 Years

**Minimum Age:** 12 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

**Study Population:** The study will include 30 scoliosis patients who visited the Department of Orthopedics and Traumatology at Gazi University Hospital and were diagnosed with idiopathic scoliosis by a specialist physician and 30 healty control without scoliosis.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** ukanatlı@gazi.edu.tr

**Name:** Ulunay Kanatlı, Proff

**Phone:** (0312) 216 26 01

**Role:** CONTACT

**Contact 2:**

**Email:** inciayass@gmail.com

**Name:** İnci H Ayas, Msc

**Phone:** (0312) 216 26 01

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Ankara

**Country:** Turkey

**Facility:** Gazi University Hospital

**Zip:** 06500

#### Overall Officials

**Official 1:**

**Affiliation:** Gazi University

**Name:** İnci H Ayas, Msc

**Role:** STUDY_DIRECTOR

**Official 2:**

**Affiliation:** Gazi University

**Name:** Furkan Aral, MD

**Role:** STUDY_CHAIR

**Official 3:**

**Affiliation:** Gazi University

**Name:** Burak Oklaz, MD

**Role:** STUDY_CHAIR

**Official 4:**

**Affiliation:** Gazi University

**Name:** Ulunay Kanatlı, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000013121

- Term: Spinal Curvatures

- ID: D000013122

- Term: Spinal Diseases

- ID: D000001847

- Term: Bone Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M15417

- Name: Scoliosis

- Relevance: HIGH

- As Found: Scoliosis

- ID: M15918

- Name: Spinal Curvatures

- Relevance: LOW

- As Found: Unknown

- ID: M15919

- Name: Spinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5126

- Name: Bone Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000012600

- Term: Scoliosis

### Misc Info Module

- Version Holder: 2024-05-31
