- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00966927
Assessment of Functional Independence and Quality of Life in Adolescents With Spina Bifid
August 26, 2009 updated by: Arcispedale Santa Maria Nuova-IRCCS
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.
Study Overview
Status
Unknown
Conditions
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 Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Manuela Lodesani, MD
- Phone Number: 5962 +38052296184
- Email: lodesani.manuela@asmn.re.it
Study Locations
-
-
-
Parma, Italy, 43126
- Recruiting
- Unit for Care of Spina Bifida
-
Contact:
- Manuela Lodesani, MD
- Phone Number: 5962 +390522296184
- Email: lodesani.manuela@asmn.re.it
-
Sub-Investigator:
- Giuliana Bossi, PT
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 21 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
subjects with spina bifid referred to primary care clinic
Description
Inclusion Criteria:
- recurrence of clinic control in Unit for Spina Bifid in Parma
- 14-21 years old
Exclusion Criteria:
- subjects unable to understand the items of the questionnaire (mental retardation and need for help at school )
- subjects without any caregiver
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
---|
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
correlation between the quality of life in adolescents and young adults with Spina Bifid and their level of functional independence
Time Frame: 5 months
|
5 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
correlation between functional level of independence and motor level of neurological lesion
Time Frame: 5 months
|
5 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Manuela Lodesani, MD, UDGEE- Unit Care of Spina Bifida Parma
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2009
Study Completion (Anticipated)
November 1, 2009
Study Registration Dates
First Submitted
August 26, 2009
First Submitted That Met QC Criteria
August 26, 2009
First Posted (Estimate)
August 27, 2009
Study Record Updates
Last Update Posted (Estimate)
August 27, 2009
Last Update Submitted That Met QC Criteria
August 26, 2009
Last Verified
August 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UDGEE-SPINA BIFIDA
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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