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

Spinal Dysraphism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00966927
• Other study ID #: UDGEE-SPINA BIFIDA
• Status: Recruiting
• Phase: N/A
• First received: August 26, 2009
• Last updated: August 26, 2009
• Start date: July 2009
• Est. completion date: November 2009

Study information

• Verified date: August 2009
• Source: Arcispedale Santa Maria Nuova-IRCCS
• Contact: Manuela Lodesani, MD
• Phone: +38052296184
• Email: lodesani.manuela[@]asmn.re.it
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years to 21 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Neural Tube Defects
• Spinal Dysraphism

Locations

Country	Name	City	State
Italy	Unit for Care of Spina Bifida	Parma

Sponsors (1)

Lead Sponsor	Collaborator
Arcispedale Santa Maria Nuova-IRCCS

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Buran CF, Sawin KJ, Brei TJ, Fastenau PS. Adolescents with myelomeningocele: activities, beliefs, expectations, and perceptions. Dev Med Child Neurol. 2004 Apr;46(4):244-52. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	correlation between the quality of life in adolescents and young adults with Spina Bifid and their level of functional independence		5 months	No
Secondary	correlation between functional level of independence and motor level of neurological lesion		5 months	No