Side Pole Static Ankle Foot Orthosis in Children With Neurological Disorders

Neurological Disorder Clinical Trial

— SPS-AFO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03146598
• Other study ID #: 2015-68
• Status: Completed
• Phase: N/A
• First received: May 2, 2017
• Last updated: May 5, 2017
• Start date: January 1, 2012
• Est. completion date: January 1, 2012

Study information

• Verified date: May 2017
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 1, 2012
• Est. primary completion date: January 1, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 16 Years

Eligibility

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:

Related Conditions & MeSH terms

• Disease
• Nervous System Diseases
• Neurological Disorder

Intervention

Other:
• No intervention as it is a observational study
No intervention as it is a observational study

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
BERTHILLIER Julien

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of the SPS AFO wearing	Duration of the SPS AFO wearing	At 3 months after SPS AFO implementation
Secondary	Frequency of the SPS AFO wearing	Frequency of the SPS AFO wearing	At 3 months after SPS AFO implementation
Secondary	Duration of the SPS AFO wearing	Duration of the SPS AFO wearing	At 1 year after SPS AFO implementation
Secondary	Frequency of the SPS AFO wearing	Frequency of the SPS AFO wearing	At 1 year after SPS AFO implementation
Secondary	Duration of the SPS AFO wearing	Duration of the SPS AFO wearing	at 2 year after SPS AFO implementation
Secondary	Frequency of the SPS AFO wearing	Frequency of the SPS AFO wearing	at 2 year after SPS AFO implementation
Secondary	Duration of the SPS AFO wearing	Duration of the SPS AFO wearing	At 4 years after SPS AFO implementation
Secondary	Frequency of the SPS AFO wearing	Frequency of the SPS AFO wearing	At 4 years after SPS AFO implementation