Motor Development and Orthoses in Spinal Muscular Atrophy (SMA)

The recruitment status of this study is unknown because the information has not been verified recently.

Verified August 2009 by Arcispedale Santa Maria Nuova-IRCCS.
Recruitment status was Not yet recruiting

Sponsor:

Information provided by:

Arcispedale Santa Maria Nuova-IRCCS

ClinicalTrials.gov Identifier:

NCT00961103

First received: August 17, 2009

Last updated: NA

Last verified: August 2009

History: No changes posted

Purpose

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
Spinal Muscular Atrophy


Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Retrospective
Official Title:	Assessment of Motor Development Related to Use of Orthoses in SMA II and III

Resource links provided by NLM:

Genetics Home Reference related topics: spinal muscular atrophy

MedlinePlus related topics: Spinal Muscular Atrophy

Genetic and Rare Diseases Information Center resources: Spinal Muscular Atrophy Spinal Muscular Atrophy Type 2

U.S. FDA Resources

Further study details as provided by Arcispedale Santa Maria Nuova-IRCCS:

Primary Outcome Measures:

time and percentage of sitting, standing, walking achievement in SMA II and SMA III [ Time Frame: aug.2009- nov.2009 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

characteristics and percentage of orthoses for postural sitting control , standing and walking in SMA II and SMA III [ Time Frame: aug. 2009 - dec.2009 ] [ Designated as safety issue: No ]


Estimated Enrollment:	70
Study Start Date:	September 2009
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts
SMA II and SMA III patients with SMA II and SMA III

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.

Eligibility


Ages Eligible for Study:	Child, Adult, Senior
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Publications:

Wang CH, Finkel RS, Bertini ES, Schroth M, Simonds A, Wong B, Aloysius A, Morrison L, Main M, Crawford TO, Trela A; Participants of the International Conference on SMA Standard of Care. Consensus statement for standard of care in spinal muscular atrophy. J Child Neurol. 2007 Aug;22(8):1027-49.


Responsible Party:	Lodesani Manuela, UDGEE Hospital S.Maria Nuova Reggi Emilia
ClinicalTrials.gov Identifier:	NCT00961103 History of Changes
Other Study ID Numbers:	UDGEE-SMA
Study First Received:	August 17, 2009
Last Updated:	August 17, 2009
Health Authority:	Italy: The Italian Medicines Agency

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

ClinicalTrials.gov processed this record on September 30, 2016

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