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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06142721
Other study ID # FEROL
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 15, 2022
Est. completion date January 15, 2023

Study information

Verified date November 2023
Source Biruni University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of the observational study is to compare static, kinematic and kinetic parameters with normal gait parameters in cases with Idiopathic toe walking (ITW) and Diparetic Cerebral Palsy (DCP) who have Gross Motor Function Classification System 1 level with the 3D Gait Analysis method, and to enable the early diagnosis of DCP and ITW. Male and female cases aged between 3-18 years will be included. This study will be carried out at Acıbadem Altunizade Hospital.


Description:

It is an observational study. The aim of the observational study is to compare static, kinematic and kinetic parameters with normal gait parameters in cases with Idiopathic toe walking (ITW) and Diparetic Cerebral Palsy (DCP) who have Gross Motor Function Classification System 1 level with the 3D Gait Analysis method, and to enable the early diagnosis of DCP and ITW. Male and female cases aged between 3-18 years will be included. This study will be carried out at Acıbadem Altunizade Hospital. 51 cases will be included in our study. These cases will be divided into three groups. The first group will consist of patients diagnosed with idioaptic toe walking (n:17), the second group will be composed of diparetic cerebral palsy (n:15) with independent ambulation, and the third group will be the control group (n:19). First, the demographic information of the cases will be recorded. With 3D walking analysis, kinetic, kinematic and static data will be collected. The analysis of the obtained data will be done with Polygon Software (Vicon, Oxford, UK). Evaluated kinetic, kinematic and static parameters will be compared between three groups. Is the lower extremity compensation of children with diparetic cerebral palsy who can walk independently more than children with idiopathic toe walking?


Recruitment information / eligibility

Status Completed
Enrollment 51
Est. completion date January 15, 2023
Est. primary completion date January 15, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 3 Years to 18 Years
Eligibility Inclusion Criteria: - Voluntary consent from family - Diagnosed with idiopathic toe walking and spastic diparesis between the ages of 3-18. - Cases with GMFCS 1 - The patients who applied to the healthy children's clinic, showed typical development, did not have any musculoskeletal and neurological problems, and wished to voluntarily participate in the study were included in the control group. Exclusion Criteria: - Refusing to participate in the study - Under the age of 3 and over the age of 18 - Not at GMFCS 1 level - Cases who did not have any orthopedic problems other than accompanying toe walking were excluded from the study.

Study Design


Intervention

Other:
3D Gait Analysis
3D gait analysis was applied to children. Static, kinematic and kinetic walking parameters were evaluated

Locations

Country Name City State
Turkey Acibadem Altunizade Hospital Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Biruni University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 3D Gait Analysis Sixteen markers defined according to the Modified Helen Heyes protocol are applied to certain anatomical regions of both lower extremities. 3D gait analysis can precisely calculate joint angles and movement patterns in all three planes. Collect spatio-temporal data. Baseline
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