Assessing the effectiveness of carbon fiber ankle foot orthoses in children with neurological conditions
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
This study tests if carbon fiber ankle foot braces can help kids and teens with neurological conditions walk better and feel more satisfied with their mobility.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 70 (estimated) |
| Ages | 4 Years to 17 Years |
| Sex | All |
| Sponsor | Otto Bock France SNC Industry-sponsored |
| Locations | 1 site (Palavas-les-Flots) |
| Trial ID | NCT06740006 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the impact of prefabricated carbon fiber ankle foot orthoses (AFO) on gait improvement and user satisfaction in children and teenagers with neurological pathologies. Participants who have previously trialed the WalkOn AFO will have their gait analyzed both with and without the orthosis. The study aims to collect and analyze biomechanical and follow-up data to determine the effectiveness of the AFO in enhancing mobility. The findings could provide insights into the benefits of using these orthoses in clinical practice.
Who should consider this trial
Good fit: Ideal candidates include children and teenagers with gait impairments due to central or peripheral motor impairments who have trialed the WalkOn AFO within the last three years.
Not a fit: Patients who have not trialed the WalkOn AFO or do not have available gait analysis data will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved mobility and quality of life for children with neurological conditions.
How similar studies have performed: While this approach is observational, similar studies assessing the effectiveness of orthotic devices have shown promising results in improving patient outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Palavas-les-Flots
- Institut Saint Pierre — Palavas-les-Flots, France (Recruiting)
Study contacts
- Study coordinator: LACROIX Aurelie
- Email: aurelie.lacroix@ottobock.com
- Phone: 786295203
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.