Neurological DisorderSPS-AFONCT03146598
Side Pole Static Ankle Foot Orthosis in Children With Neurological Disorders
An observational study of Neurological Disorder, run by BERTHILLIER Julien.
Trial summary
Transverse-plane foot deformities are a frequently encountered issue in children with neurological disorders. They are the source of many symptoms, such as pain and walking difficulties, making their prevention very important. Read more about this study
- Who is it for?
- Ages 1 year to 16 years
- Conditions the study is for
- Neurological Disorder
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2012to 1 Jan 2012
- 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 1 year to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Patient from the department of physical medicine and pediatric rehabilitation L'Escale (Lyon, France)
Who may be able to join
- regularly follow-up in the department of physical medicine and pediatric rehabilitation L'Escale (Lyon, France)
- presenting at least unilateral transverse-plane foot deformity within the context of a neurological disorder
- having a first prescription of SPS AFO between December 2001 and December 2011.
Who cannot join
- None
About this study
Official title: Use and Tolerability of a Side Pole Static Ankle Foot Orthosis in Children With Neurological Disorders
Transverse-plane foot deformities are a frequently encountered issue in children with neurological disorders. They are the source of many symptoms, such as pain and walking difficulties, making their prevention very important. It is thus important to prevent the occurrence of transverse-plane foot deformities and limit their development regarding the high risk of morbidity. In order to prevent such deformities, in the department of pediatric physical medicine and rehabilitation department of Lyon, since 2001 the investigator use a side pole static ankle foot orthosis (SPS AFO) in children with a neurological disorder predisposing such deformities. The aim of the study this study is to describe the use, tolerability and potential side effects of this orthosis in children with neurological disorders from the investigator's department
- Conditions
- Neurological Disorder
- Being tested
- No intervention as it is a observational study
- Keywords
- Foot deformity, Orthopaedic management, prevention, side pole static ankle foot orthosis
- Medical subject headings
- Nervous System Diseases, Foot Deformities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention as it is a observational studyOther
No intervention as it is a observational study
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of the SPS AFO wearing
Duration of the SPS AFO wearing
Measured: At 3 months after SPS AFO implementation
Secondary outcomes (7)
Frequency of the SPS AFO wearing
Frequency of the SPS AFO wearing
Measured: At 3 months after SPS AFO implementation
Duration of the SPS AFO wearing
Duration of the SPS AFO wearing
Measured: At 1 year after SPS AFO implementation
Frequency of the SPS AFO wearing
Frequency of the SPS AFO wearing
Measured: At 1 year after SPS AFO implementation
Duration of the SPS AFO wearing
Duration of the SPS AFO wearing
Measured: at 2 year after SPS AFO implementation
Frequency of the SPS AFO wearing
Frequency of the SPS AFO wearing
Measured: at 2 year after SPS AFO implementation
Duration of the SPS AFO wearing
Duration of the SPS AFO wearing
Measured: At 4 years after SPS AFO implementation
Frequency of the SPS AFO wearing
Frequency of the SPS AFO wearing
Measured: At 4 years after SPS AFO implementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2017
- Study start1 Jan 2012
- Primary completion1 Jan 2012
- Study completion1 Jan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurological DisorderStudies 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- BERTHILLIER Julien
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, BERTHILLIER Julien, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03146598
- Sponsor's protocol ID
- 2015-68
- Acronym
- SPS-AFO
- Status last verified
- May 2017
- First submitted
- 2 May 2017
- Last updated
- 10 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use and Tolerability of a Side Pole Static Ankle Foot Orthosis in Children With Neurological Disorders
- ClinicalTrials.gov ID
- NCT03146598
- Acronym / sponsor ID
- SPS-AFO / 2015-68
- Conditions
- Neurological Disorder
- Keywords
- Foot deformity, Orthopaedic management, prevention, side pole static ankle foot orthosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- BERTHILLIER JulienUniversity, hospital or other
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 1 Jan 2012 (actual)
- Study completion
- 1 Jan 2012 (actual)
- First posted
- 10 May 2017 (actual)
- 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.
Transverse-plane foot deformities are a frequently encountered issue in children with neurological disorders. They are the source of many symptoms, such as pain and walking difficulties, making their prevention very important. It is thus important to prevent the occurrence of transverse-plane foot deformities and limit their development regarding the high risk of morbidity. In order to prevent such deformities, in the department of pediatric physical medicine and rehabilitation department of Lyon, since 2001 the investigator use a side pole static ankle foot orthosis (SPS AFO) in children with a neurological disorder predisposing such deformities. The aim of the study this study is to describe the use, tolerability and potential side effects of this orthosis in children with neurological disorders from the investigator's department
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 year to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patient from the department of physical medicine and pediatric rehabilitation L'Escale (Lyon, France)
Key inclusion criteria (3 listed)
- regularly follow-up in the department of physical medicine and pediatric rehabilitation L'Escale (Lyon, France)
- presenting at least unilateral transverse-plane foot deformity within the context of a neurological disorder
- having a first prescription of SPS AFO between December 2001 and December 2011.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention as it is a observational studyNo intervention as it is a observational study | Other | – |
Primary outcome
Duration of the SPS AFO wearing
Time frame: At 3 months after SPS AFO implementation
Duration of the SPS AFO wearing
7 secondary outcomes
Frequency of the SPS AFO wearing
Time frame: At 3 months after SPS AFO implementation
Duration of the SPS AFO wearing
Time frame: At 1 year after SPS AFO implementation
Frequency of the SPS AFO wearing
Time frame: At 1 year after SPS AFO implementation
Duration of the SPS AFO wearing
Time frame: at 2 year after SPS AFO implementation
Frequency of the SPS AFO wearing
Time frame: at 2 year after SPS AFO implementation
Duration of the SPS AFO wearing
Time frame: At 4 years after SPS AFO implementation
Frequency of the SPS AFO wearing
Time frame: At 4 years after SPS AFO implementation
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 10 May 2017.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurological Disorder, run by BERTHILLIER Julien.
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 3 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 10 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Duration of the SPS AFO wearing (time frame: At 3 months after SPS AFO implementation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 May 2017.