Motor Development and Orthoses in Spinal Muscular Atrophy... | NCT00961103

Studies
Motor Development and Orthoses in Spinal Muscular Atrophy (SMA)

NCT00961103

Sponsor

Azienda USL Reggio Emilia - IRCCS

Status

Completed

Last Update Posted

Dec 23, 2025Actual

Enrollment

80Actual

Phase

Not provided

Conditions

Spinal Muscular Atrophy

Interventions

Not provided

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 12, 2009Actual

Primary Completion Date

Nov 1, 2009Actual

Completion Date

Apr 4, 2011Actual

First Submitted Date

Aug 17, 2009

First Submission Date that Met QC Criteria

Aug 17, 2009

First Posted Date

Aug 18, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 17, 2025

Last Update Posted Date

Dec 23, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Label	Type	Description	Intervention Names
SMA II and SMA III		patients with SMA II and SMA III

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
time and percentage of sitting, standing, walking achievement in SMA II and SMA III		aug.2009- nov.2009

Secondary Outcomes

Measure	Description	Time Frame
characteristics and percentage of orthoses for postural sitting control , standing and walking in SMA II and SMA III		aug. 2009 - dec.2009

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical and genetics diagnosis of SMA II and SMA III

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

patients with SMA II and SMA III referred to UDGEE for rehabilitation consultation

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Adriano Ferrari, MD	Hospital S.Maria Nuova Reggio Emilia Italy	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UDGEE Hospital S.Maria Nuova		Reggio Emilia	RE	42100	Italy

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17761659	Background	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. doi: 10.1177/0883073807305788.

ID	Term
D013118	Spinal Cord Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D016472	Motor Neuron Disease