Clinical trial NCT06740006: Retrospective Study on the WalkOn AFO in Children or Teenagers with Neurological Pathologies
Official 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cerebral Palsy (CP)
Spastic Paraplegia
Spinal Cord Injuries (SCI)
Spina Bifida
Neuropathy (Disorder)
Lead sponsor: Otto Bock France SNC
Sponsor class: INDUSTRY
First posted: 2024-12-18
Enrollment: 70
Sex: ALL
Minimum age (years): 4
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
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

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.


Eligibility 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

Primary outcomes:
measure: Stride length
timeFrame: After 1 hour with the device
Secondary outcomes:
measure: Walking speed
timeFrame: After 1 hour with the device
measure: Walking cadence
timeFrame: After 1 hour with the device
measure: Gait Profile Score
timeFrame: After 1 hour with the device
measure: Gait Variable Score for the Hip
timeFrame: After 1 hour with the device
measure: Gait Variable Score for the Knee
timeFrame: After 1 hour with the device
measure: Gait Variable Score for the Ankle
timeFrame: After 1 hour with the device
measure: Walk ratio
timeFrame: After 1 hour with the device
measure: Antero-posterior Ground Force Reaction
timeFrame: Afer 1 hour with the device
measure: Time of Stance
timeFrame: After 1 hour with the device
measure: Stance percentage
timeFrame: After 1 hour with the device
measure: Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST)
timeFrame: Between 3 to 18 months after the fitting with the device / Long-term follow-up visit
Other outcomes:
Locations:
city: Palavas-les-Flots
country: France
facility: Institut Saint Pierre
Study officials:
References: