CClinicalTrials.gg
CompletedNCT03146598SPS-AFOUpdated May 10, 2017

Side Pole Static Ankle Foot Orthosis in Children With Neurological Disorders

An observational study in Neurological Disorder, sponsored by BERTHILLIER Julien. Completed. Open to participants aged 1 Year to 16 Years. Per ClinicalTrials.gov, last updated 2017-05-10.

Sponsored by BERTHILLIER Julien · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
100
Ages
1 Year to 16 Years
Sex
All
01

Study 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

02

Conditions studied

  • Neurological Disorder

Keywords

  • Foot deformity
  • Orthopaedic management
  • prevention
  • side pole static ankle foot orthosis
03

In context

Nervous System Diseases

974 studies on the registry are indexed under Nervous System Diseases; 252 are open to participants now.

This study's enrollment of 100 is below the median of 127 across 318 observational studies indexed under Nervous System Diseases.

Browse Nervous System Diseases studies →

Lead sponsor

BERTHILLIER Julien is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 16 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patient from the department of physical medicine and pediatric rehabilitation L'Escale (Lyon, France)

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • None
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
100 participants (actual)
Patient registry
No

Interventions

  • OtherNo intervention as it is a observational study

    No intervention as it is a observational study

06

What researchers measure

Primary outcomes

  1. Duration of the SPS AFO wearing

    Duration of the SPS AFO wearing

    Time frame: At 3 months after SPS AFO implementation

Secondary outcomes

  1. Frequency of the SPS AFO wearing

    Frequency of the SPS AFO wearing

    Time frame: At 3 months after SPS AFO implementation

  2. Duration of the SPS AFO wearing

    Duration of the SPS AFO wearing

    Time frame: At 1 year after SPS AFO implementation

  3. Frequency of the SPS AFO wearing

    Frequency of the SPS AFO wearing

    Time frame: At 1 year after SPS AFO implementation

  4. Duration of the SPS AFO wearing

    Duration of the SPS AFO wearing

    Time frame: at 2 year after SPS AFO implementation

  5. Frequency of the SPS AFO wearing

    Frequency of the SPS AFO wearing

    Time frame: at 2 year after SPS AFO implementation

  6. Duration of the SPS AFO wearing

    Duration of the SPS AFO wearing

    Time frame: At 4 years after SPS AFO implementation

  7. Frequency of the SPS AFO wearing

    Frequency of the SPS AFO wearing

    Time frame: At 4 years after SPS AFO implementation

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 10, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03146598
Lead sponsor
BERTHILLIER Julien
Responsible party
BERTHILLIER Julien (Project manager, Hospices Civils de Lyon) — Sponsor-investigator
First posted
May 10, 2017
Start date
Jan 1, 2012
Primary completion
Jan 1, 2012
Completion
Jan 1, 2012
Last update
May 10, 2017

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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