NCT00966927

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
41

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 27, 2009

Completed
11.9 years until next milestone

Study Start

First participant enrolled

July 1, 2021

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

June 24, 2025

Status Verified

June 1, 2025

Enrollment Period

4.4 years

First QC Date

August 26, 2009

Last Update Submit

June 18, 2025

Conditions

Spinal Dysraphism

Keywords

quality of lifefunctional independencespina bifid

Outcome Measures

Primary Outcomes (1)

  • correlation between the quality of life in adolescents and young adults with Spina Bifid and their level of functional independence

    5 months

Secondary Outcomes (1)

  • correlation between functional level of independence and motor level of neurological lesion

    5 months

Study Arms (1)

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

Eligibility Criteria

Age14 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

subjects with spina bifid referred to primary care clinic

You may qualify if:

  • recurrence of clinic control in Unit for Spina Bifid in Parma
  • years old

You may not qualify if:

  • subjects unable to understand the items of the questionnaire (mental retardation and need for help at school )
  • subjects without any caregiver

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unit for Care of Spina Bifida

Parma, Parma, 43126, Italy

Location

Related 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. doi: 10.1017/s0012162204000404.

    PMID: 15077702BACKGROUND

MeSH Terms

Conditions

Spinal Dysraphism

Condition Hierarchy (Ancestors)

Neural Tube DefectsNervous System MalformationsNervous System DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2009

First Posted

August 27, 2009

Study Start

July 1, 2021

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

June 24, 2025

Record last verified: 2025-06

Locations

IT(1)