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Completed

NCT Number: NCT06740006

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

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.

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Key information

Conditions

Cerebral Palsy (CP) Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Nervous System Diseases Nervous System Malformations Neural Tube Defects Neurologic Manifestations Neuropathy (Disorder) Paralysis Paraplegia Pathological Conditions, Signs and Symptoms Signs and Symptoms Spastic Paraplegia Spina Bifida Spinal Cord Diseases Spinal Cord Injuries Spinal Cord Injuries (SCI) Spinal Dysraphism Trauma, Nervous System Wounds and Injuries

Age range

4 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Institut Saint Pierre

Palavas-les-Flots, 34250, France

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. Stride length

    Time frame: After 1 hour with the device

    Biomechanical parameter: the distance between successive points of initial contact of the same foot (m)

Secondary outcomes

  1. Walking speed

    Time frame: After 1 hour with the device

    Biomechanical parameter: the walking speed is the time one takes to walk a specified distance on level surfaces over a short distance (m/s).

  2. Walking cadence

    Time frame: After 1 hour with the device

    Biomechanical parameter: the walking rate is equal to the walking speed divided by the stride lenth (steps/min).

  3. Gait Profile Score

    Time frame: After 1 hour with the device

    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 (°).

  4. Gait Variable Score for the Hip

    Time frame: After 1 hour with the device

    Biomechanical parameter: the Gait Variable Score describes the joint specific measures of gait variability for the Hip (°).

  5. Gait Variable Score for the Knee

    Time frame: After 1 hour with the device

    Biomechanicl parameter: the Gait Variable Score describes the joint specific measures of gait variability for the Knee (°).

  6. Gait Variable Score for the Ankle

    Time frame: After 1 hour with the device

    Biomechanical parameter: the Gait Variable Score describes the joint specific measures of gait variability for the Ankle (°).

  7. Walk ratio

    Time frame: After 1 hour with the device

    Biomechanical parameter: the walk ration represents the relationship between the amplitude and frequency of rhythmic leg movement during walking (m/step/min).

  8. Antero-posterior Ground Force Reaction

    Time frame: Afer 1 hour with the device

    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).

  9. Time of Stance

    Time frame: After 1 hour with the device

    Biomechanical parameter: the time of stance is the time one spend with the foot on the floor (s)

  10. Stance percentage

    Time frame: After 1 hour with the device

    Biomechanical parameter: the stance percentage is the percentage of time one spend with the foot on the floor during the gait cycle (%)

  11. Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST)

    Time frame: Between 3 to 18 months after the fitting with the device / Long-term follow-up visit

    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.

Sponsors and collaborators

Lead sponsor

Otto Bock France SNC

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Dec 18, 2024
Registry last updated
Sep 24, 2025

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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