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

NCT ID: NCT06740006

Last Updated: 2025-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

65 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-09-03

Study Completion Date

2025-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

4 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Otto Bock France SNC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Institut Saint Pierre

Palavas-les-Flots, , France

Site Status

Countries

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France

Other Identifiers

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BP-11-PT008

Identifier Type: -

Identifier Source: org_study_id

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