Assessment of Functional Independence and Quality of Life... | NCT00966927

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

NCT00966927

Sponsor

Azienda USL Reggio Emilia - IRCCS

Status

Active, not recruiting

Last Update Posted

Jun 24, 2025Actual

Enrollment

41Actual

Phase

Not provided

Conditions

Spinal Dysraphism

Interventions

Not provided

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2021Actual

Primary Completion Date

Dec 2025Estimated

Completion Date

Dec 2025Estimated

First Submitted Date

Aug 26, 2009

First Submission Date that Met QC Criteria

Aug 26, 2009

First Posted Date

Aug 27, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 18, 2025

Last Update Posted Date

Jun 24, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

41Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
correlation between the quality of life in adolescents and young adults with Spina Bifid and their level of functional independence		5 months

Secondary Outcomes

Measure	Description	Time Frame
correlation between functional level of independence and motor level of neurological lesion		5 months

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

21 Years

Standard Ages

ChildAdult

Study Population

subjects with spina bifid referred to primary care clinic

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Unit for Care of Spina Bifida		Parma	Parma	43126	Italy

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15077702	Background	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.

ID	Term
D009436	Neural Tube Defects
D009421	Nervous System Malformations
D009422	Nervous System Diseases
D000013	Congenital Abnormalities