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Motor Development and Orthoses in Spinal Muscular Atrophy (SMA)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2009 by Arcispedale Santa Maria Nuova-IRCCS.
Recruitment status was:  Not yet recruiting
Information provided by:
Arcispedale Santa Maria Nuova-IRCCS Identifier:
First received: August 17, 2009
Last updated: NA
Last verified: August 2009
History: No changes posted

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.

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:

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 ]

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 ]

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)
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.


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

Inclusion Criteria:

  • Clinical and genetics diagnosis of SMA II and SMA III

Exclusion Criteria:

  Contacts and Locations
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Please refer to this study by its identifier: NCT00961103

Contact: Manuela Lodesani, MD +390522296184 ext 5962

UDGEE Hospital S.Maria Nuova Not yet recruiting
Reggio Emilia, RE, Italy, 42100
Contact: Manuela Lodesani, MD    +390522296184 ext 5962   
Sub-Investigator: Mariacristina Filippi, PT         
Sponsors and Collaborators
Arcispedale Santa Maria Nuova-IRCCS
Study Director: Adriano Ferrari, MD Hospital S.Maria Nuova Reggio Emilia Italy
  More Information

Responsible Party: Lodesani Manuela, UDGEE Hospital S.Maria Nuova Reggi Emilia Identifier: NCT00961103     History of Changes
Other Study ID Numbers: UDGEE-SMA
Study First Received: August 17, 2009
Last Updated: August 17, 2009

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

Additional relevant MeSH terms:
Muscular Atrophy
Muscular Atrophy, Spinal
Spinal Cord Diseases
Pathological Conditions, Anatomical
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Central Nervous System Diseases
Motor Neuron Disease
Neurodegenerative Diseases
Neuromuscular Diseases processed this record on September 21, 2017