Investigation of Gait Pattern in Idiopathic Scoliosis

Idiopathic Scoliosis Clinical Trial

Official title:

Investigation of Gait Pattern in Idiopathic Scoliosis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06433167
• Other study ID #: Iayas9
• Status: Not yet recruiting
• Start date: June 15, 2024
• Est. completion date: January 30, 2025

Study information

• Verified date: May 2024
• Source: Gazi University
• Contact: Ulunay Kanatli, Proff
• Phone: (0312) 216 26 01
• Email: ukanatli[@]gazi.edu.tr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: January 30, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Idiopathic Scoliosis
• Scoliosis

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Turkey	Gazi University Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pedobarography	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.	Day 1