Physical Capacity of Spina Bifida and Factors Affecting

Physical Capacity of Spina Bifida and Factors Affecting During Pregnancy: A Case Control Study

Objective: It was aimed to evaluate the physical characteristics of the cases with spina bifida and to review the factors that may affect the etiology of the disease.

Methods: 48 cases with spina bifida and 48 control groups in other disease groups evaluated. A physiotherapist physically evaluated the cases after their personal information was obtained. A survey form examining the possible factors in the etiology of spina bifida was applied to the families.

Study Overview

• Status: Completed
• Conditions: Spina Bifida
• Intervention / Treatment: Other: case-control study

Detailed Description

The study was carried out with the participation of 48 cases with spina bifida between the ages of 0 and 2 evaluated in XXXXXX Training and Research Hospital (XXXXX) Pediatric Clinics and 48 control groups in other disease groups in response to each case.

The case group consisted of patients who were diagnosed in the Neonatal Intensive Care Unit between February 2019 and January 2020 (39 children), and who applied to the Physiotherapy and Rehabilitation Department from the centers outside for physiotherapy needs (9 children).

• Study Type: Observational
• Enrollment (Actual): 2

Contacts and Locations

Study Locations

• Turkey
  • Diyarbakır, Turkey, 21090
    • University of Health Sciences, Diyarbakır Gazi Yaşargil Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

The case group consisted of patients who were diagnosed in the Neonatal Intensive Care Unit between February 2019 and January 2020 (39 children), and who applied to the Physiotherapy and Rehabilitation Department from the centers outside for physiotherapy needs (9 children). The control group was formed through random selection among the children who were at the same age group between the same dates, did not have any diseases related to the neuromuscular system, and hospitalized for any other reason.

Description

Inclusion Criteria:

• spina bifida between the ages of 0 and 2

Exclusion Criteria:

• control group was formed through random selection among the children who were at the same age group between the same dates, did not have any diseases related to the neuromuscular system, and hospitalized for any other reason.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
case; The case group consisted of patients who were diagnosed in the Neonatal Intensive Care Unit (39 children), and who applied to the Physiotherapy and Rehabilitation Department from the centers outside for physiotherapy needs (9 children).	Other: case-control study; physical examination and Survey Form
Control; the children who were at the same age group between the same dates, did not have any diseases related to the neuromuscular system, and hospitalized for any other reason.	Other: case-control study; physical examination and Survey Form

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Results of Groups	FACTORS AFFECTING DURING PREGNANCY QUESTIONARRE	1-2 month
Antropomethric measures	body mass index (kg/cm2)	1-2 month

Collaborators and Investigators

• Sponsor: Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2019
• Primary Completion (Actual): January 1, 2020
• Study Completion (Actual): January 1, 2020

Study Registration Dates

• First Submitted: July 14, 2024
• First Submitted That Met QC Criteria: August 2, 2024
• First Posted (Actual): August 7, 2024

Study Record Updates

• Last Update Posted (Actual): August 7, 2024
• Last Update Submitted That Met QC Criteria: August 2, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Congenital Abnormalities; Nervous System Malformations; Neural Tube Defects; Spinal Dysraphism
• Other Study ID Numbers: SBUGaziYasargil21

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