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

• Sponsor: Istanbul Medipol University Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05540730
• Collaborator: Medipol University (Other)
• Enrollment: 29
• Location: 1
• Anticipated Duration (Months): 45
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Brachial Plexus Palsy; Gait Disorders in Children	Diagnostic Test: Gait Analysis

Study Design

• Study Type: Observational
• Anticipated Enrollment: 29 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Analysis of Foot Plantar Pressure Behavior of Children With Obstetric Brachial Plexus Paralysis
• Actual Study Start Date: Mar 3, 2019
• Anticipated Primary Completion Date: Nov 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Stance Time [during gait analysis.]

   stance time phase during walking

Secondary Outcome Measures

1. Step Length [during gait analysis.]

2. Ground reaction force [during gait analysis.]

3. Single limb support phase [during gait analysis.]

   Single limb support phase during walking

Eligibility Criteria

Criteria

• Ages Eligible for Study: 7 Years to 15 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Istanbul Medipol University	Istanbul		Turkey	34815

Sponsors and Collaborators

• Istanbul Medipol University Hospital
• Medipol University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Istanbul Medipol University Hospital
• ClinicalTrials.gov Identifier: NCT05540730
• Other Study ID Numbers: IstanbulMUH-DPTR-Yozdemir-0094
• First Posted: Sep 15, 2022
• Last Update Posted: Sep 15, 2022
• Last Verified: Sep 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Istanbul Medipol University Hospital: Brachial Plexus Palsy; Gait Disorders in Children; Biomechanics; Gait Analysis
• Additional relevant MeSH terms: Paralysis

Study Results

No Results Posted as of Sep 15, 2022