CompletedNot Applicable

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

France65 participantsStarted 2024-09-03

Plain-language 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.

Who can participate

Age range

4 Years – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Stride length

Timeframe: After 1 hour with the device

Trial details

NCT IDNCT06740006

SponsorOtto Bock France SNC

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-12-06

View on ClinicalTrials.gov More Cerebral Palsy (CP) trials