Motor Development and Orthoses in Spinal Muscular Atrophy (SMA)

August 17, 2009 updated by: Arcispedale Santa Maria Nuova-IRCCS

Assessment of Motor Development Related to Use of Orthoses in SMA II and III

Spinal Muscular Atrophy (SMA) is neurodegenerative disease of anterior horn cells of spinal cord and represents the second more frequent pathology in childhood.

According to the age of onset and the maximum motor function the disorder is classified in 4 types. Patients with SMA II and SMA III often use orthoses to achieve postural and dynamic functions.

In this retrospective observational study the investigators describe the characteristics of sitting position, standing and walking correlated to type and time of orthoses used.

Study Overview

Status

Unknown

Conditions

Detailed Description

We collect data from patients with SMA II and SMA III referred to UDGEE from jan. 1995 to dec. 2008.

We estimate to achieve informations about 50-70 patients.

Study Type

Observational

Enrollment (Anticipated)

70

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

  • Italy
    • RE
      • Reggio Emilia, RE, Italy, 42100
        • UDGEE Hospital S.Maria Nuova
        • Contact:
        • Sub-Investigator:
          • Mariacristina Filippi, 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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with SMA II and SMA III referred to UDGEE for rehabilitation consultation

Description

Inclusion Criteria:

  • Clinical and genetics diagnosis of SMA II and SMA III

Exclusion Criteria:

  • N/A

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

Cohorts and Interventions

Group / Cohort
SMA II and SMA III
patients with SMA II and SMA III

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
time and percentage of sitting, standing, walking achievement in SMA II and SMA III
Time Frame: aug.2009- nov.2009
aug.2009- nov.2009

Secondary Outcome Measures

Outcome Measure
Time Frame
characteristics and percentage of orthoses for postural sitting control , standing and walking in SMA II and SMA III
Time Frame: aug. 2009 - dec.2009
aug. 2009 - dec.2009

Collaborators and Investigators

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

Sponsor

Arcispedale Santa Maria Nuova-IRCCS

Investigators

  • Study Director: Adriano Ferrari, MD, Hospital S.Maria Nuova Reggio Emilia Italy

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.

General Publications

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

September 1, 2009

Primary Completion (Anticipated)

November 1, 2009

Study Completion (Anticipated)

December 1, 2009

Study Registration Dates

First Submitted

August 17, 2009

First Submitted That Met QC Criteria

August 17, 2009

First Posted (Estimate)

August 18, 2009

Study Record Updates

Last Update Posted (Estimate)

August 18, 2009

Last Update Submitted That Met QC Criteria

August 17, 2009

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UDGEE-SMA

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.

Clinical Trials on Spinal Muscular Atrophy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in India

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe