Spina BifidaNCT06541366
Physical Capacity of Spina Bifida and Factors Affecting
An observational study of Spina Bifida, run by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 2 years
- Conditions the study is for
- Spina Bifida
- How many people
- 2 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2019to 1 Jan 2020
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 2 years
- All sexes
- Child
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.
Who may be able to join
- spina bifida between the ages of 0 and 2
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences, Diyarbakır Gazi Yaşargil Training and Research Hospital
Diyarbakır, 21090
About this study
Official title: 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.
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).
- Conditions
- Spina Bifida
- Being tested
- case-control study
- Medical subject headings
- Spinal Dysraphism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
case-control studyOther
physical examination and Survey Form
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Other: case-control study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Results of Groups
FACTORS AFFECTING DURING PREGNANCY QUESTIONARRE
Measured: 1-2 month
Antropomethric measures
body mass index (kg/cm2)
Measured: 1-2 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start1 Feb 2019
- Primary completion1 Jan 2020
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spina BifidaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 2 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammed ARCA, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06541366
- Sponsor's protocol ID
- SBUGaziYasargil21
- Status last verified
- Aug 2024
- First submitted
- 14 Jul 2024
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Capacity of Spina Bifida and Factors Affecting During Pregnancy: A Case Control Study
- ClinicalTrials.gov ID
- NCT06541366
- Acronym / sponsor ID
- SBUGaziYasargil21
- Conditions
- Spina Bifida
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Saglik Bilimleri Universitesi Gazi Yasargil Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 7 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Other
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| case | – | Other: case-control studyThe 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). |
| Control | – | Other: case-control studythe 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. |
Who may qualify
- Ages
- 0 to 2 years
- Sex
- All
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- spina bifida between the ages of 0 and 2
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| case-control studyphysical examination and Survey Form | Other | Control, case |
Primary outcome
Results of Groups
Time frame: 1-2 month
FACTORS AFFECTING DURING PREGNANCY QUESTIONARRE
Antropomethric measures
Time frame: 1-2 month
body mass index (kg/cm2)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- Individual participant dataSharing planned: No
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EVALUATION OF THE SAFETY AND EFFICACY OF ADJUSTABLE CONTINENT THERAPY IN CHILDREN WITH SPINAL DYSRAPHISM.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spina Bifida, run by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Results of Groups (time frame: 1-2 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2024.