Motor Development and Orthoses in Spinal Muscular Atrophy (SMA)

Spinal Muscular Atrophy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00961103
• Other study ID #: UDGEE-SMA
• Status: Not yet recruiting
• Phase: N/A
• First received: August 17, 2009
• Last updated: August 17, 2009
• Start date: September 2009
• Est. completion date: December 2009

Study information

• Verified date: August 2009
• Source: Arcispedale Santa Maria Nuova-IRCCS
• Contact: Manuela Lodesani, MD
• Phone: +390522296184
• Email: lodesani.manuela[@]asmn.re.it
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: December 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Clinical and genetics diagnosis of SMA II and SMA III

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Atrophy
• Muscular Atrophy
• Muscular Atrophy, Spinal
• Spinal Muscular Atrophy

Locations

Country	Name	City	State
Italy	UDGEE Hospital S.Maria Nuova	Reggio Emilia	RE

Sponsors (1)

Lead Sponsor	Collaborator
Arcispedale Santa Maria Nuova-IRCCS

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time and percentage of sitting, standing, walking achievement in SMA II and SMA III		aug.2009- nov.2009	No
Secondary	characteristics and percentage of orthoses for postural sitting control , standing and walking in SMA II and SMA III		aug. 2009 - dec.2009	No