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

Sponsor
Arcispedale Santa Maria Nuova-IRCCS (Other)
Overall Status
Unknown status
CT.gov ID
NCT00966927
Collaborator
(none)
100
Enrollment
1
Location
4
Duration (Months)
24.7
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Anticipated 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 :
    Jul 1, 2009
    Anticipated Study Completion Date :
    Nov 1, 2009

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

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

    Secondary Outcome Measures

    1. correlation between functional level of independence and motor level of neurological lesion [5 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    14 Years to 21 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Unit for Care of Spina Bifida Parma Italy 43126

    Sponsors and Collaborators

    • Arcispedale Santa Maria Nuova-IRCCS

    Investigators

    • Principal Investigator: Manuela Lodesani, MD, UDGEE- Unit Care of Spina Bifida Parma

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00966927
    Other Study ID Numbers:
    • UDGEE-SPINA BIFIDA
    First Posted:
    Aug 27, 2009
    Last Update Posted:
    Aug 27, 2009
    Last Verified:
    Aug 1, 2009
    Keywords provided by , ,
    quality of life
    functional independence
    spina bifid
    Additional relevant MeSH terms:
    Spinal Dysraphism
    Neural Tube Defects

    Study Results

    No Results Posted as of Aug 27, 2009