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

NCT06740006 | Completed

• 1 other identifier: BP-11-PT008
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cerebral Palsy (CP); Spastic Paraplegia; Spinal Cord Injuries (SCI); Spina Bifida; Neuropathy (Disorder)

Outcome Measures

Primary Outcomes (1)

• Stride length

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

  After 1 hour with the device

Secondary Outcomes (11)

• Walking speed

  After 1 hour with the device

• Walking cadence

  After 1 hour with the device

• Gait Profile Score

  After 1 hour with the device

• Gait Variable Score for the Hip

  After 1 hour with the device

• Gait Variable Score for the Knee

  After 1 hour with the device

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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

You may qualify if:

• Patient, child or adolescent, whose gait is affected by central or peripheral motor impairments
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Otto Bock France SNC: lead

Study Sites (1)

Institut Saint Pierre

Palavas-les-Flots, 34250, France

Location

MeSH Terms

Conditions

Cerebral Palsy; Paraplegia; Spinal Cord Injuries; Spinal Dysraphism

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Cord Diseases; Trauma, Nervous System; Wounds and Injuries; Neural Tube Defects; Nervous System Malformations; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2024
• First Posted: December 18, 2024
• Study Start: September 3, 2024
• Primary Completion: December 6, 2024
• Study Completion: February 28, 2025
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)