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Assessment of Functional Independence and Quality of Life in Adolescents With Spina Bifid

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ClinicalTrials.gov Identifier: NCT00966927
Recruitment Status : Unknown
Verified August 2009 by Arcispedale Santa Maria Nuova-IRCCS.
Recruitment status was:  Recruiting
First Posted : August 27, 2009
Last Update Posted : August 27, 2009
Sponsor:
Information provided by:
Arcispedale Santa Maria Nuova-IRCCS

Brief 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.

Condition or disease
Spinal Dysraphism

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
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Assessment of Functional Independence and Quality of Life in Italian Population of Adolescents With Spina Bifid
Study Start Date : July 2009
Estimated Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Spina Bifida

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



Primary Outcome Measures :
  1. correlation between the quality of life in adolescents and young adults with Spina Bifid and their level of functional independence [ Time Frame: 5 months ]

Secondary Outcome Measures :
  1. correlation between functional level of independence and motor level of neurological lesion [ Time Frame: 5 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
subjects with spina bifid referred to primary care clinic
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00966927


Contacts
Contact: Manuela Lodesani, MD +38052296184 ext 5962 lodesani.manuela@asmn.re.it

Locations
Italy
Unit for Care of Spina Bifida Recruiting
Parma, Italy, 43126
Contact: Manuela Lodesani, MD    +390522296184 ext 5962    lodesani.manuela@asmn.re.it   
Sub-Investigator: Giuliana Bossi, PT         
Sponsors and Collaborators
Arcispedale Santa Maria Nuova-IRCCS
Investigators
Principal Investigator: Manuela Lodesani, MD UDGEE- Unit Care of Spina Bifida Parma

Publications:
Responsible Party: Lodesani Manuela, arcispedale S.Maria Nuova Reggio Emilia, affilaition with Unit for Care of Spina Bifida -Parma
ClinicalTrials.gov Identifier: NCT00966927     History of Changes
Other Study ID Numbers: UDGEE-SPINA BIFIDA
First Posted: August 27, 2009    Key Record Dates
Last Update Posted: August 27, 2009
Last Verified: August 2009

Keywords provided by Arcispedale Santa Maria Nuova-IRCCS:
quality of life
functional independence
spina bifid

Additional relevant MeSH terms:
Spinal Dysraphism
Neural Tube Defects
Nervous System Malformations
Nervous System Diseases
Congenital Abnormalities