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

August 26, 2009 updated by: Arcispedale Santa Maria Nuova-IRCCS

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

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.

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Parma, Italy, 43126
        • Recruiting
        • Unit for Care of Spina Bifida
        • Contact:
        • Sub-Investigator:
          • Giuliana Bossi, PT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

subjects with spina bifid referred to primary care clinic

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Manuela Lodesani, MD, UDGEE- Unit Care of Spina Bifida Parma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Study Completion (Anticipated)

November 1, 2009

Study Registration Dates

First Submitted

August 26, 2009

First Submitted That Met QC Criteria

August 26, 2009

First Posted (Estimate)

August 27, 2009

Study Record Updates

Last Update Posted (Estimate)

August 27, 2009

Last Update Submitted That Met QC Criteria

August 26, 2009

Last Verified

August 1, 2009

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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