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Trial record 18 of 33 for:    "Spina bifida"
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Assessment of Functional Independence and Quality of Life in Adolescents With Spina Bifid

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Arcispedale Santa Maria Nuova-IRCCS.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Arcispedale Santa Maria Nuova-IRCCS
ClinicalTrials.gov Identifier:
NCT00966927
First received: August 26, 2009
Last updated: NA
Last verified: August 2009
History: No changes posted
  Purpose

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
Spinal Dysraphism

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Arcispedale Santa Maria Nuova-IRCCS:

Primary Outcome Measures:
  • correlation between the quality of life in adolescents and young adults with Spina Bifid and their level of functional independence [ Time Frame: 5 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • correlation between functional level of independence and motor level of neurological lesion [ Time Frame: 5 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: July 2009
Estimated Study Completion Date: November 2009
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   14 Years to 21 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

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
Study First Received: August 26, 2009
Last Updated: August 26, 2009
Health Authority: Italy: Ministry of Health

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

ClinicalTrials.gov processed this record on May 16, 2013