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Trial record 56 of 119 for:    "Progressive Muscular Atrophy"

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

Tracking Information
First Submitted Date August 17, 2009
First Posted Date August 18, 2009
Last Update Posted Date August 18, 2009
Study Start Date September 2009
Estimated Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 17, 2009)
time and percentage of sitting, standing, walking achievement in SMA II and SMA III [ Time Frame: aug.2009- nov.2009 ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: August 17, 2009)
characteristics and percentage of orthoses for postural sitting control , standing and walking in SMA II and SMA III [ Time Frame: aug. 2009 - dec.2009 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Motor Development and Orthoses in Spinal Muscular Atrophy (SMA)
Official Title Assessment of Motor Development Related to Use of Orthoses in SMA II and III
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.

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
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population patients with SMA II and SMA III referred to UDGEE for rehabilitation consultation
Condition Spinal Muscular Atrophy
Intervention Not Provided
Study Groups/Cohorts SMA II and SMA III
patients with SMA II and SMA III
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: August 17, 2009)
70
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2009
Estimated Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Clinical and genetics diagnosis of SMA II and SMA III

Exclusion Criteria:

  • N/A
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT00961103
Other Study ID Numbers UDGEE-SMA
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Lodesani Manuela, UDGEE Hospital S.Maria Nuova Reggi Emilia
Study Sponsor Arcispedale Santa Maria Nuova-IRCCS
Collaborators Not Provided
Investigators
Study Director: Adriano Ferrari, MD Hospital S.Maria Nuova Reggio Emilia Italy
PRS Account Arcispedale Santa Maria Nuova-IRCCS
Verification Date August 2009