Analysis of Foot Plantar Pressure Behavior of Children With Obstetric Brachial Plexus Paralysis

April 30, 2025 updated by: Yunus Özdemir, PhD, Istanbul Medipol University Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

29

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34815
        • Istanbul Medipol University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 15 years (Child)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Children with obstetric brachial plexus paralysis

Description

Inclusion Criteria:

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

Exclusion Criteria:

- 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control
Diagnostic test: Gait Analysis
Foot plantar pressure with pedobarography and arm swing with video camera will be analyzed.
Obstetric brachial plexus paralysis
Diagnostic test: Gait Analysis
Foot plantar pressure with pedobarography and arm swing with video camera will be analyzed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stance Time
Time Frame: during gait analysis.
stance time phase during walking
during gait analysis.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Step Length
Time Frame: during gait analysis.
during gait analysis.
Ground reaction force
Time Frame: during gait analysis.
during gait analysis.
Single limb support phase
Time Frame: during gait analysis.
Single limb support phase during walking
during gait analysis.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Medipol University Hospital

Collaborators

Medipol University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 24, 2017

Primary Completion (Actual)

May 1, 2021

Study Completion (Actual)

July 1, 2022

Study Registration Dates

First Submitted

September 12, 2022

First Submitted That Met QC Criteria

September 12, 2022

First Posted (Actual)

September 15, 2022

Study Record Updates

Last Update Posted (Actual)

May 4, 2025

Last Update Submitted That Met QC Criteria

April 30, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IstanbulMUH-DPTR-Yozdemir-0094

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Gait Disorders in Children

Clinical Trials on Gait Analysis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Netherlands

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe