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

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 Overview

• Status: Completed
• Conditions: Neurological Disorder
• Intervention / Treatment: Other: No intervention as it is a observational study

• Study Type: Observational
• Enrollment (Actual): 100

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of the SPS AFO wearing	Duration of the SPS AFO wearing	At 3 months after SPS AFO implementation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of the SPS AFO wearing	Frequency of the SPS AFO wearing	At 3 months after SPS AFO implementation
Duration of the SPS AFO wearing	Duration of the SPS AFO wearing	At 1 year after SPS AFO implementation
Frequency of the SPS AFO wearing	Frequency of the SPS AFO wearing	At 1 year after SPS AFO implementation
Duration of the SPS AFO wearing	Duration of the SPS AFO wearing	at 2 year after SPS AFO implementation
Frequency of the SPS AFO wearing	Frequency of the SPS AFO wearing	at 2 year after SPS AFO implementation
Duration of the SPS AFO wearing	Duration of the SPS AFO wearing	At 4 years after SPS AFO implementation
Frequency of the SPS AFO wearing	Frequency of the SPS AFO wearing	At 4 years after SPS AFO implementation

Collaborators and Investigators

• Sponsor: BERTHILLIER Julien

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2012
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: May 2, 2017
• First Submitted That Met QC Criteria: May 5, 2017
• First Posted (Actual): May 10, 2017

Study Record Updates

• Last Update Posted (Actual): May 10, 2017
• Last Update Submitted That Met QC Criteria: May 5, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: prevention; Foot deformity; Orthopaedic management; side pole static ankle foot orthosis
• Additional Relevant MeSH Terms: Nervous System Diseases
• Other Study ID Numbers: 2015-68

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No