Side Pole Static Ankle Foot Orthosis in Children With Neurological Disorders
SPS-AFO
Use and Tolerability of a Side Pole Static Ankle Foot Orthosis in Children With Neurological Disorders
1 other identifier
observational
100
0 countries
N/A
Brief 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. 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2012
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
Study Start
First participant enrolled
January 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 2, 2017
CompletedFirst Posted
Study publicly available on registry
May 10, 2017
CompletedMay 10, 2017
May 1, 2017
Same day
May 2, 2017
May 5, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Duration of the SPS AFO wearing
Duration of the SPS AFO wearing
At 3 months after SPS AFO implementation
Secondary Outcomes (7)
Frequency of the SPS AFO wearing
At 3 months after SPS AFO implementation
Duration of the SPS AFO wearing
At 1 year after SPS AFO implementation
Frequency of the SPS AFO wearing
At 1 year after SPS AFO implementation
Duration of the SPS AFO wearing
at 2 year after SPS AFO implementation
Frequency of the SPS AFO wearing
at 2 year after SPS AFO implementation
- +2 more secondary outcomes
Interventions
No intervention as it is a observational study
Eligibility Criteria
Patient from the department of physical medicine and pediatric rehabilitation L'Escale (Lyon, France)
You may qualify if:
- 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.
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Project manager
Study Record Dates
First Submitted
May 2, 2017
First Posted
May 10, 2017
Study Start
January 1, 2012
Primary Completion
January 1, 2012
Study Completion
January 1, 2012
Last Updated
May 10, 2017
Record last verified: 2017-05
Data Sharing
- IPD Sharing
- Will not share