Spinal DysraphismNCT00966927
Assessment of Functional Independence and Quality of Life in Adolescents With Spina Bifid
An observational study of Spinal Dysraphism, run by Azienda USL Reggio Emilia - IRCCS at 1 site in Italy.
Trial summary
The purpose of this study is to investigate the level of functional independence and the quality of life of adolescents and young adults with spina bifid in an Italian population. Read more about this study
- Who is it for?
- Ages 14 to 21 years
- Conditions the study is for
- Spinal Dysraphism
- How many people
- 41 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2021to Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 14 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: subjects with spina bifid referred to primary care clinic
Who may be able to join
- recurrence of clinic control in Unit for Spina Bifid in Parma
- 14-21 years old
Who cannot join
- subjects unable to understand the items of the questionnaire (mental retardation and need for help at school )
- subjects without any caregiver
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Functional Independence and Quality of Life in Italian Population of Adolescents With Spina Bifid
The purpose of this study is to investigate the level of functional independence and the quality of life of adolescents and young adults with spina bifid in an Italian population.
Read the detailed description
We submitted the Quality of Life in spina bifid Questionnaire to subjects who participated in the study and the Spinal Cord Independence Measure to the parents of subjects.
- Conditions
- Spinal Dysraphism
- Keywords
- quality of life, functional independence, spina bifid
- Medical subject headings
- Spinal Dysraphism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| subjects with spina bifid | subjects with spina bifid between 14 and 21 years old referred to Unit for Care of Spina Bifid Hospital of Parma |
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation between the quality of life in adolescents and young adults with Spina Bifid and their level of functional independence
Measured: 5 months
Secondary outcomes (1)
correlation between functional level of independence and motor level of neurological lesion
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2009 (estimated)
- Study start1 Jul 2021
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal DysraphismStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCS
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00966927
- Sponsor's protocol ID
- UDGEE-SPINA BIFIDA
- Status last verified
- Jun 2025
- First submitted
- 26 Aug 2009
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Buran CF, Sawin KJ, Brei TJ, Fastenau PS. Adolescents with myelomeningocele: activities, beliefs, expectations, and perceptions. Dev Med Child Neurol. 2004 Apr;46(4):244-52. doi: 10.1017/s0012162204000404.
PubMed 15077702
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Functional Independence and Quality of Life in Italian Population of Adolescents With Spina Bifid
- ClinicalTrials.gov ID
- NCT00966927
- Acronym / sponsor ID
- UDGEE-SPINA BIFIDA
- Conditions
- Spinal Dysraphism
- Keywords
- quality of life, functional independence, spina bifid
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCSOther government
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 27 Aug 2009 (estimated)
- 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.
The purpose of this study is to investigate the level of functional independence and the quality of life of adolescents and young adults with spina bifid in an Italian population.
Detailed description
We submitted the Quality of Life in spina bifid Questionnaire to subjects who participated in the study and the Spinal Cord Independence Measure to the parents of subjects.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| subjects with spina bifid | – | –subjects with spina bifid between 14 and 21 years old referred to Unit for Care of Spina Bifid Hospital of Parma |
Who may qualify
- Ages
- 14 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- subjects with spina bifid referred to primary care clinic
Key inclusion criteria (2 listed)
- recurrence of clinic control in Unit for Spina Bifid in Parma
- 14-21 years old
Key exclusion criteria (2 listed)
- subjects unable to understand the items of the questionnaire (mental retardation and need for help at school )
- subjects without any caregiver
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
correlation between the quality of life in adolescents and young adults with Spina Bifid and their level of functional independence
Time frame: 5 months
1 secondary outcome
correlation between functional level of independence and motor level of neurological lesion
Time frame: 5 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
- Background: PubMed 15077702Buran CF, Sawin KJ, Brei TJ, Fastenau PS. Adolescents with myelomeningocele: activities, beliefs, expectations, and perceptions. Dev Med Child Neurol. 2004 Apr;46(4):244-52. doi: 10.1017/s0012162204000404.
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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 Spinal Dysraphism, run by Azienda USL Reggio Emilia - IRCCS at 1 site in Italy.
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 2 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 24 Jun 2025. 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
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?
correlation between the quality of life in adolescents and young adults with Spina Bifid and their level of functional independence (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00966927, which also lists 1 linked publication.
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 24 Jun 2025.