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CompletedNCT06541366Updated Aug 7, 2024

Physical Capacity of Spina Bifida and Factors Affecting

An observational study in Spina Bifida, sponsored by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital. Completed at 1 site in Turkey. Open to participants aged 0 Years to 2 Years. Per ClinicalTrials.gov, last updated 2024-08-07.

Sponsored by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Other
Enrollment
2
Ages
0 Years to 2 Years
Sex
All
01

Study summary

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.

Read the 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).

02

Conditions studied

  • Spina Bifida

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03

In context

Spinal Dysraphism

152 studies on the registry are indexed under Spinal Dysraphism; 37 are open to participants now.

This study's enrollment of 2 is below the median of 91 across 54 observational studies indexed under Spinal Dysraphism.

Browse Spinal Dysraphism studies →

Lead sponsor

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital is the lead sponsor of 56 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
0 Years to 2 Years
Sexes eligible
All
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.

Inclusion criteria

  • spina bifida between the ages of 0 and 2

Exclusion criteria

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.
05

Study design

Observational model
Case-control
Time perspective
Other
Enrollment
2 participants (actual)
Target follow-up
1 Year
Patient registry
Yes

Groups and cohorts

  • 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

  • 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

Interventions

  • Othercase-control study

    physical examination and Survey Form

06

What researchers measure

Primary outcomes

  1. Results of Groups

    FACTORS AFFECTING DURING PREGNANCY QUESTIONARRE

    Time frame: 1-2 month

  2. Antropomethric measures

    body mass index (kg/cm2)

    Time frame: 1-2 month

07

Study locations

1 site
  • University of Health Sciences, Diyarbakır Gazi Yaşargil Training and Research Hospital
    Diyarbakır, 21090, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 7, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06541366
Lead sponsor
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Responsible party
Muhammed ARCA (Dr., Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital) — Principal investigator
First posted
Aug 7, 2024
Start date
Feb 1, 2019
Primary completion
Jan 1, 2020
Completion
Jan 1, 2020
Last update
Aug 7, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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