NCT06740006已完成不适用
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
Otto Bock France SNC1 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2024年9月3日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Stride length
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 4 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Patients or holders of parental authority objecting to the processing of data within the framework of the study
结局指标
主要结局
Stride length
时间窗: After 1 hour with the device
Biomechanical parameter: the distance between successive points of initial contact of the same foot (m)
次要结局
- Walking speed(After 1 hour with the device)
- Walking cadence(After 1 hour with the device)
- Gait Profile Score(After 1 hour with the device)
- Gait Variable Score for the Hip(After 1 hour with the device)
- Gait Variable Score for the Knee(After 1 hour with the device)
- Gait Variable Score for the Ankle(After 1 hour with the device)
- Walk ratio(After 1 hour with the device)
- Antero-posterior Ground Force Reaction(Afer 1 hour with the device)
- Time of Stance(After 1 hour with the device)
- Stance percentage(After 1 hour with the device)
- 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)
研究者
研究点 (1)
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