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

Recruiting

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

• Registration Number: NCT06740006
• Lead Sponsor: Otto Bock France SNC

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-08-29
• Study Start: 2024-09-03
• Status Verified: 2024-12
• Study First Submitted QC: 2024-12-13
• Last Update Submitted: 2024-12-13
• Study First Posted: 2024-12-18
• Last Update Posted: 2024-12-18
• Primary Completion: 2025-02-28
• Study Completion: 2025-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Stride length	After 1 hour with the device	Biomechanical parameter: the distance between successive points of initial contact of the same foot (m)

Secondary Outcome Measures

Name	Time	Method
Walking speed	After 1 hour with the device	Biomechanical parameter: the walking speed is the time one takes to walk a specified distance on level surfaces over a short distance (m/s).
Walking cadence	After 1 hour with the device	Biomechanical parameter: the walking rate is equal to the walking speed divided by the stride lenth (steps/min).
Gait Profile Score	After 1 hour with the device	Biomechanical parameter: the Gait Profile Score (GPS) is a clinical index that can be used to measure the overall deviation of gait data relative to normative data (°).
Gait Variable Score for the Hip	After 1 hour with the device	Biomechanical parameter: the Gait Variable Score describes the joint specific measures of gait variability for the Hip (°).
Gait Variable Score for the Knee	After 1 hour with the device	Biomechanicl parameter: the Gait Variable Score describes the joint specific measures of gait variability for the Knee (°).
Gait Variable Score for the Ankle	After 1 hour with the device	Biomechanical parameter: the Gait Variable Score describes the joint specific measures of gait variability for the Ankle (°).
Walk ratio	After 1 hour with the device	Biomechanical parameter: the walk ration represents the relationship between the amplitude and frequency of rhythmic leg movement during walking (m/step/min).
Antero-posterior Ground Force Reaction	Afer 1 hour with the device	Biomechanical parameter: the antero-posterior Ground Force Reaction is the antero-posterior force exerted by the ground on a body in contact with it (N).
Time of Stance	After 1 hour with the device	Biomechanical parameter: the time of stance is the time one spend with the foot on the floor (s)
Stance percentage	After 1 hour with the device	Biomechanical parameter: the stance percentage is the percentage of time one spend with the foot on the floor during the gait cycle (%)
Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST)	Between 3 to 18 months after the fitting with the device / Long-term follow-up visit	Questionnaire: the QUEST measures the user satisfaction. It contains an evaluation part regarding the technology of the device on 8 items and one regarding services around the device on 4 items. It allows the patient to express himself on the criteria that are most important to him. An average satisfaction value can be calculated on a scale going from 1 to 5, with 1= "Not at all satisfied", 2="Not very satisfied", 3="more or less satisfied", 4="Quite satisfied" or 5="Very satisfied". The final QUEST score is the average obtained over all 12 items. Technology and services sub-scores can also be calculated.; In this study, the french version ESAT (Evaluation des la Satisfaction envers une Aide Technique) is used.; This questionnaire only concerns patients who purchase the orthosis, and was administered during a follow-up visit of the patient in the rehabilitation center.

Trial Locations

Locations (1)

Institut Saint Pierre; 🇫🇷 Palavas-les-Flots, France