NCT06142721

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 5, 2023

Completed
9 months until next milestone

First Posted

Study publicly available on registry

November 21, 2023

Completed
Last Updated

November 21, 2023

Status Verified

November 1, 2023

Enrollment Period

4 months

First QC Date

March 5, 2023

Last Update Submit

November 20, 2023

Conditions

Keywords

Toe walkingcerebral palsyidiopathic toe walking3D gait analysis

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

ITW Group

3D gait analysis was applied to children with idiopathic toe walking. Static, kinematic and kinetic walking parameters were evaluated.

Other: 3D Gait Analysis

DCP Group

3D gait analysis was applied to diparetic children who were able to walk independently. Static, kinematic and kinetic walking parameters were evaluated.

Other: 3D Gait Analysis

Healthy Group

3D gait analysis was applied to healthy children. Static, kinematic and kinetic walking parameters were evaluated.

Other: 3D Gait Analysis

Interventions

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

DCP GroupHealthy GroupITW Group

Eligibility Criteria

Age3 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

A total of 51 cases, including 17 ITW(female:4;male:13), 15 DCP(female:5;male:10) and 19 Control groups (female:6;male:13), were included.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Acıbadem Altunizade Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Fatih Erol

    Biruni University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 5, 2023

First Posted

November 21, 2023

Study Start

September 15, 2022

Primary Completion

January 15, 2023

Study Completion

January 15, 2023

Last Updated

November 21, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be made available to other researchers.

Locations