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Motor Development and Orthoses in Spinal Muscular Atrophy (SMA)

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ClinicalTrials.gov Identifier: NCT00961103
Recruitment Status : Unknown
Verified August 2009 by Arcispedale Santa Maria Nuova-IRCCS.
Recruitment status was:  Not yet recruiting
First Posted : August 18, 2009
Last Update Posted : August 18, 2009
Sponsor:
Information provided by:
Arcispedale Santa Maria Nuova-IRCCS

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

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.


Condition or disease
Spinal Muscular Atrophy

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 Design
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Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Assessment of Motor Development Related to Use of Orthoses in SMA II and III
Study Start Date : September 2009
Estimated Primary Completion Date : November 2009
Estimated Study Completion Date : December 2009

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U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. time and percentage of sitting, standing, walking achievement in SMA II and SMA III [ Time Frame: aug.2009- nov.2009 ]

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

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with SMA II and SMA III referred to UDGEE for rehabilitation consultation
Criteria

Inclusion Criteria:

  • Clinical and genetics diagnosis of SMA II and SMA III

Exclusion Criteria:

Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00961103


Contacts
Contact: Manuela Lodesani, MD +390522296184 ext 5962 lodesani.manuela@asmn.re.it

Locations
Italy
UDGEE Hospital S.Maria Nuova Not yet recruiting
Reggio Emilia, RE, Italy, 42100
Contact: Manuela Lodesani, MD    +390522296184 ext 5962    lodesani.manuela@asmn.re.it   
Sub-Investigator: Mariacristina Filippi, PT         
Sponsors and Collaborators
Arcispedale Santa Maria Nuova-IRCCS
Investigators
Study Director: Adriano Ferrari, MD Hospital S.Maria Nuova Reggio Emilia Italy
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Responsible Party: Lodesani Manuela, UDGEE Hospital S.Maria Nuova Reggi Emilia
ClinicalTrials.gov Identifier: NCT00961103     History of Changes
Other Study ID Numbers: UDGEE-SMA
First Posted: August 18, 2009    Key Record Dates
Last Update Posted: August 18, 2009
Last Verified: August 2009

Keywords provided by Arcispedale Santa Maria Nuova-IRCCS:
spinal muscular atrophy
motor development
orthoses

Additional relevant MeSH terms:
Atrophy
Muscular Atrophy
Muscular Atrophy, Spinal
Pathological Conditions, Anatomical
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
 Signs and Symptoms
Spinal Cord Diseases
Central Nervous System Diseases
Motor Neuron Disease
Neurodegenerative Diseases
Neuromuscular Diseases