Investigation of Gait Pattern in Idiopathic Scoliosis

NCT ID: NCT06433167

Last Updated: 2024-05-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-06-15
• Study Completion Date: 2025-01-30

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

Idiopathic Scoliosis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Idiopathic Scoliosis

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.

Pedobarographic analysis

Intervention Type: OTHER

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.

Healthy control

Healthy control group is healthy individuals without any diagnosed disease.

Pedobarographic analysis

Intervention Type: OTHER

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.

Interventions

Pedobarographic analysis

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Gazi University

OTHER

Sponsor Role: lead

Responsible Party

İnci Hazal Ayas

Research asistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

İnci H Ayas, Msc

Role: STUDY_DIRECTOR

Gazi University

Furkan Aral, MD

Role: STUDY_CHAIR

Gazi University

Burak Oklaz, MD

Role: STUDY_CHAIR

Gazi University

Ulunay Kanatlı, MD

Role: PRINCIPAL_INVESTIGATOR

Gazi University

Locations

Gazi University Hospital

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

Ulunay Kanatlı, Proff

Role: CONTACT

ukanatlı@gazi.edu.tr

(0312) 216 26 01

İnci H Ayas, Msc

Role: CONTACT

inciayass@gmail.com

(0312) 216 26 01

Other Identifiers

Iayas9

Identifier Type: -

Identifier Source: org_study_id