NCT00961103

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 18, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

October 12, 2009

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 4, 2011

Completed
Last Updated

December 23, 2025

Status Verified

September 1, 2025

Enrollment Period

20 days

First QC Date

August 17, 2009

Last Update Submit

December 17, 2025

Conditions

Keywords

spinal muscular atrophymotor developmentorthoses

Outcome Measures

Primary Outcomes (1)

  • time and percentage of sitting, standing, walking achievement in SMA II and SMA III

    aug.2009- nov.2009

Secondary Outcomes (1)

  • characteristics and percentage of orthoses for postural sitting control , standing and walking in SMA II and SMA III

    aug. 2009 - dec.2009

Study Arms (1)

SMA II and SMA III

patients with SMA II and SMA III

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Clinical and genetics diagnosis of SMA II and SMA III

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UDGEE Hospital S.Maria Nuova

Reggio Emilia, RE, 42100, Italy

Location

Related 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. doi: 10.1177/0883073807305788.

    PMID: 17761659BACKGROUND

MeSH Terms

Conditions

Muscular Atrophy, Spinal

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesMotor Neuron DiseaseNeurodegenerative DiseasesNeuromuscular Diseases

Study Officials

  • Adriano Ferrari, MD

    Hospital S.Maria Nuova Reggio Emilia Italy

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2009

First Posted

August 18, 2009

Study Start

October 12, 2009

Primary Completion

November 1, 2009

Study Completion

April 4, 2011

Last Updated

December 23, 2025

Record last verified: 2025-09

Locations