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Completed

NCT Number: NCT03146598

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

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Key information

Conditions

Neurological Disorder Foot Deformities Musculoskeletal Diseases Nervous System Diseases

Age range

1 year–16 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • None

Treatment and study plan

No intervention as it is a observational study

Other

No intervention as it is a observational study

Primary outcomes

  1. Duration of the SPS AFO wearing

    Time frame: At 3 months after SPS AFO implementation

    Duration of the SPS AFO wearing

Secondary outcomes

  1. Frequency of the SPS AFO wearing

    Time frame: At 3 months after SPS AFO implementation

    Frequency of the SPS AFO wearing

  2. Duration of the SPS AFO wearing

    Time frame: At 1 year after SPS AFO implementation

    Duration of the SPS AFO wearing

  3. Frequency of the SPS AFO wearing

    Time frame: At 1 year after SPS AFO implementation

    Frequency of the SPS AFO wearing

  4. Duration of the SPS AFO wearing

    Time frame: at 2 year after SPS AFO implementation

    Duration of the SPS AFO wearing

  5. Frequency of the SPS AFO wearing

    Time frame: at 2 year after SPS AFO implementation

    Frequency of the SPS AFO wearing

  6. Duration of the SPS AFO wearing

    Time frame: At 4 years after SPS AFO implementation

    Duration of the SPS AFO wearing

  7. Frequency of the SPS AFO wearing

    Time frame: At 4 years after SPS AFO implementation

    Frequency of the SPS AFO wearing

Sponsors and collaborators

Lead sponsor

BERTHILLIER Julien

Other

Registry information

Official study title

Use and Tolerability of a Side Pole Static Ankle Foot Orthosis in Children With Neurological Disorders

Acronym: SPS-AFO

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
May 10, 2017
Registry last updated
May 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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