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
Information provided by:
Arcispedale Santa Maria Nuova-IRCCS Identifier:
First received: August 26, 2009
Last updated: NA
Last verified: August 2009
History: No changes posted
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.

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:

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
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.

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00966927

Contact: Manuela Lodesani, MD +38052296184 ext 5962

Unit for Care of Spina Bifida Recruiting
Parma, Italy, 43126
Contact: Manuela Lodesani, MD    +390522296184 ext 5962   
Sub-Investigator: Giuliana Bossi, PT         
Sponsors and Collaborators
Arcispedale Santa Maria Nuova-IRCCS
Principal Investigator: Manuela Lodesani, MD UDGEE- Unit Care of Spina Bifida Parma
  More Information

Responsible Party: Lodesani Manuela, arcispedale S.Maria Nuova Reggio Emilia, affilaition with Unit for Care of Spina Bifida -Parma 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:
Neural Tube Defects
Spinal Dysraphism
Congenital Abnormalities
Nervous System Diseases
Nervous System Malformations processed this record on May 23, 2016