Spinal Muscular AtrophyNCT00961103
Motor Development and Orthoses in Spinal Muscular Atrophy (SMA)
An observational study of Spinal Muscular Atrophy, run by Azienda USL Reggio Emilia - IRCCS at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Spinal Muscular Atrophy
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 12 Oct 2009to 4 Apr 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with SMA II and SMA III referred to UDGEE for rehabilitation consultation
Who may be able to join
- Clinical and genetics diagnosis of SMA II and SMA III
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Motor Development Related to Use of Orthoses in SMA II and III
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.
Read the 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.
- Conditions
- Spinal Muscular Atrophy
- Keywords
- spinal muscular atrophy, motor development, orthoses
- Medical subject headings
- Muscular Atrophy, Spinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| SMA II and SMA III | patients with SMA II and SMA III |
What is being measured
The primary outcome is the main question the study is designed to answer.
time and percentage of sitting, standing, walking achievement in SMA II and SMA III
Measured: 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
Measured: aug. 2009 - dec.2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2009 (estimated)
- Study start12 Oct 2009
- Primary completion1 Nov 2009
- Study completion4 Apr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Muscular AtrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCS
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Adriano Ferrari, MD, Study director, Hospital S.Maria Nuova Reggio Emilia Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00961103
- Sponsor's protocol ID
- UDGEE-SMA
- Status last verified
- Sep 2025
- First submitted
- 17 Aug 2009
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
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. doi: 10.1177/0883073807305788.
PubMed 17761659
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Motor Development Related to Use of Orthoses in SMA II and III
- ClinicalTrials.gov ID
- NCT00961103
- Acronym / sponsor ID
- UDGEE-SMA
- Conditions
- Spinal Muscular Atrophy
- Keywords
- spinal muscular atrophy, motor development, orthoses
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCSOther government
- Study start
- 12 Oct 2009 (actual)
- Primary completion
- 1 Nov 2009 (actual)
- Study completion
- 4 Apr 2011 (actual)
- First posted
- 18 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SMA II and SMA III | – | –patients with SMA II and SMA III |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with SMA II and SMA III referred to UDGEE for rehabilitation consultation
Key inclusion criteria (1 listed)
- Clinical and genetics diagnosis of SMA II and SMA III
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
time and percentage of sitting, standing, walking achievement in SMA II and SMA III
Time frame: aug.2009- nov.2009
1 secondary outcome
characteristics and percentage of orthoses for postural sitting control , standing and walking in SMA II and SMA III
Time frame: aug. 2009 - dec.2009
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Background: PubMed 17761659Wang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adriano Ferrari, MD study director
Hospital S.Maria Nuova Reggio Emilia Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Muscular Atrophy, run by Azienda USL Reggio Emilia - IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time and percentage of sitting, standing, walking achievement in SMA II and SMA III (time frame: aug.2009- nov.2009). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00961103, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.