Retrospective Study on the WalkOn AFO in Children or Teenagers With Neurological Pathologies

Interest of Prefabricated Carbon Orthoses in the Therapeutic Arsenal of Children and Adolescents Affected by Central or Peripheral Neurological Pathologies: Retrospective Study on Gait Parameters and Prescription Criteria

The goal of this observational study is to assess the interest of prefabricated carbon fiber ankle foot orthoses (AFO) in children and teenagers with central or peripheral neurological pathologies. The main question it aims to answer is:

Does prefabricated carbon AFO improve gait and provide user satisfaction? In current practice, all patients with gait impairments were fitted with this orthosis and had a 3D gait analysis with and without AFO. Biomecanical and follow-up data collected in current practice are analysed in this study in order to answer the question.

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy (CP); Spina Bifida; Spinal Cord Injuries (SCI); Spastic Paraplegia; Neuropathy (Disorder)

• Study Type: Observational
• Enrollment (Actual): 65

Contacts and Locations

Study Locations

• France
  • Palavas-les-Flots, France, 34250
    • Institut Saint Pierre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Children or tennagers whose gait is affected by central or peripheral motor impairments and who are followed in the rehabilitation center

Description

Inclusion Criteria:

• Patient, child or adolescent, whose gait is affected by central or peripheral motor impairments
• Patient who has carried out a one-off trial of a WalkOn AFO (Ankle-Foot Orthosis) within the last 3 years prior to the beginning of the study (inclusion period)
• Patient whose quantified gait analysis with the WalkOn AFO and without orthosis is available in the medical file and whose date is within the inclusion period
• The investigator has verified that the patient and the parental authorities have received the information note concerning the study
• The investigator has verified that the person and the parental authorities do not object to the processing of data necessary for the study

Exclusion Criteria:

• Patients or holders of parental authority objecting to the processing of data within the framework of the study

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stride length	Biomechanical parameter: the distance between successive points of initial contact of the same foot (m)	After 1 hour with the device

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Walking speed	Biomechanical parameter: the walking speed is the time one takes to walk a specified distance on level surfaces over a short distance (m/s).	After 1 hour with the device
Walking cadence	Biomechanical parameter: the walking rate is equal to the walking speed divided by the stride lenth (steps/min).	After 1 hour with the device
Gait Profile Score	Biomechanical parameter: the Gait Profile Score (GPS) is a clinical index that can be used to measure the overall deviation of gait data relative to normative data (°).	After 1 hour with the device
Gait Variable Score for the Hip	Biomechanical parameter: the Gait Variable Score describes the joint specific measures of gait variability for the Hip (°).	After 1 hour with the device
Gait Variable Score for the Knee	Biomechanicl parameter: the Gait Variable Score describes the joint specific measures of gait variability for the Knee (°).	After 1 hour with the device
Gait Variable Score for the Ankle	Biomechanical parameter: the Gait Variable Score describes the joint specific measures of gait variability for the Ankle (°).	After 1 hour with the device
Walk ratio	Biomechanical parameter: the walk ration represents the relationship between the amplitude and frequency of rhythmic leg movement during walking (m/step/min).	After 1 hour with the device
Antero-posterior Ground Force Reaction	Biomechanical parameter: the antero-posterior Ground Force Reaction is the antero-posterior force exerted by the ground on a body in contact with it (N).	Afer 1 hour with the device
Time of Stance	Biomechanical parameter: the time of stance is the time one spend with the foot on the floor (s)	After 1 hour with the device
Stance percentage	Biomechanical parameter: the stance percentage is the percentage of time one spend with the foot on the floor during the gait cycle (%)	After 1 hour with the device
Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST)	Questionnaire: the QUEST measures the user satisfaction. It contains an evaluation part regarding the technology of the device on 8 items and one regarding services around the device on 4 items. It allows the patient to express himself on the criteria that are most important to him. An average satisfaction value can be calculated on a scale going from 1 to 5, with 1= "Not at all satisfied", 2="Not very satisfied", 3="more or less satisfied", 4="Quite satisfied" or 5="Very satisfied". The final QUEST score is the average obtained over all 12 items. Technology and services sub-scores can also be calculated. In this study, the french version ESAT (Evaluation des la Satisfaction envers une Aide Technique) is used. This questionnaire only concerns patients who purchase the orthosis, and was administered during a follow-up visit of the patient in the rehabilitation center.	Between 3 to 18 months after the fitting with the device / Long-term follow-up visit

Collaborators and Investigators

• Sponsor: Otto Bock France SNC

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2024
• Primary Completion (Actual): December 6, 2024
• Study Completion (Actual): February 28, 2025

Study Registration Dates

• First Submitted: August 29, 2024
• First Submitted That Met QC Criteria: December 13, 2024
• First Posted (Actual): December 18, 2024

Study Record Updates

• Last Update Posted (Estimated): September 24, 2025
• Last Update Submitted That Met QC Criteria: September 23, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Congenital Abnormalities; Trauma, Nervous System; Brain Damage, Chronic; Spinal Cord Diseases; Nervous System Malformations; Neural Tube Defects; Paralysis; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Cerebral Palsy; Spinal Cord Injuries; Spinal Dysraphism; Paraplegia
• Other Study ID Numbers: BP-11-PT008

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
• product manufactured in and exported from the U.S.: No