NCT05540730

Brief Summary

The aim of this study was to investigate the foot plantar pressure behavior alterations during gait for children with obstetric brachial plexus (OBBP). 19 children with OBBP and 10 healthy children will be included in the study. The inclusion criteria of the study were to be between the ages of 7-15, not have a history of surgery or botox in the last 6 months, and not have any other disease. Foot plantar pressures of all participants will be analyzed with a pedobarography device. For arm swing analysis, a video camera will be recorded during walking and arm flexion/extension angles will be measured with Kinovea software.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2017

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 24, 2017

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2022

Completed
Last Updated

May 4, 2025

Status Verified

April 1, 2025

Enrollment Period

4.3 years

First QC Date

September 12, 2022

Last Update Submit

April 30, 2025

Conditions

Keywords

Brachial Plexus PalsyGait Disorders in ChildrenBiomechanicsGait Analysis

Outcome Measures

Primary Outcomes (1)

  • Stance Time

    stance time phase during walking

    during gait analysis.

Secondary Outcomes (3)

  • Step Length

    during gait analysis.

  • Ground reaction force

    during gait analysis.

  • Single limb support phase

    during gait analysis.

Study Arms (2)

Obstetric brachial plexus paralysis

Diagnostic Test: Gait Analysis

Control

Diagnostic Test: Gait Analysis

Interventions

Gait AnalysisDIAGNOSTIC_TEST

Foot plantar pressure with pedobarography and arm swing with video camera will be analyzed.

ControlObstetric brachial plexus paralysis

Eligibility Criteria

Age7 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Children with obstetric brachial plexus paralysis

You may qualify if:

  • \- Between the ages of 7-15. No other disease

You may not qualify if:

  • \- Having undergone surgery or botox intervention for orthopedic problems in the last 6 months.
  • Having health problems in the unaffected extremity or adversely affecting general body health.
  • The participant's parent has not signed the consent form.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol University

Istanbul, 34815, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Gait Analysis

Intervention Hierarchy (Ancestors)

GaitPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosisPhysical Functional PerformancePhysical FitnessHealthPopulation Characteristics

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

September 12, 2022

First Posted

September 15, 2022

Study Start

January 24, 2017

Primary Completion

May 1, 2021

Study Completion

July 1, 2022

Last Updated

May 4, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations