Comparison of Conventionally Manufactured Lower Leg Orthoses and Modular Customized Lower Leg Orthoses (AFO 4.0) in Patients With Limited Neuromuscular Foot Function During Overground Walking
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Gait Profile Score (GPS)
研究概览
简要总结
The Investigator will investigate the difference in the gait pattern between 2 commercially available ankle foot orthoses (AFO): a) conventionally manufactured AFO and b) modular customized AFO using Industry 4.0 technology.
Measurement method: The participants perform an instrumented gait analyses while overground walking at a self - selected speed using a conventionally manufactured AFO or a modular customized AFO.
详细描述
Cerebral palsy (CP) is the most common movement disorder in children [Stavsky, 2017]. It is frequently accompanied by spasticity [Baker, 2009]. The typical symptoms of spastic cerebral palsy are gait abnormalities such as equinus and drop foot that lead to severe impairments in daily life [Armand, 2016]. As these symptoms will persist in adulthood, an AFO is frequently required in this patient population.
Furthermore, other neurological diseases e.g stroke [Choo, 2021], spinal cord injury, and peripheral nerve injury may require the daily use of an AFO.
Ankle-foot orthoses (AFO) have been suggested to improve the dynamic efficiency of the gait. In addition, a positive effects on gait kinetics and kinematics have been reported [Figueiredo, 2008].
Recently, modular customized AFO are increasingly proposed as their response can be tuned to the patient's gait characteristics and/or functional maturity [6]. However, the evidence on this topic is still lacking and modular customized AFO are not yet established in clinical routine.
The aim of this study is to assess gait parameters with an instrumented gait analysis of the modular customized AFO compared to conventional, untuned AFO in a group of adolescents and a group of adults using for there daily activity an AFO, while over ground walking at self selected speed over a distance of about 10 m.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 11 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants fulfilling all of the following inclusion criteria are eligible for the study:
- •Patients (11-18 yrs.), who need a new orthosis (visit to an orthopedic technician)
- •Patients (18-65 yrs.), who need a new orthosis (visit to an orthopedic technician)
- •Informed Consent provided as documented by signature
- •Confirmed diagnosis of cerebral palsy
- •Confirmed diagnosis of spastic equinus and/ or drop foot,
- •Gait pathologies treated with conventional AFO
- •Gross Motor Function Classification System (GMFCS) level I or II
排除标准
- •Other neuromuscular diseases
- •Surgical intervention lower extremities past 12 months to improve gait pathologies
- •Injections of Botulinum toxin 6 months prior to study inclusion
- •Inability or unwillingness to follow the procedures of the gait analysis
- •in women: pregnancy
研究组 & 干预措施
Modular customized AFO
Walks better at self selected speed with a modular customized AFO than with a conventional AFO.
干预措施: Modular customized AFO (Device)
结局指标
主要结局
Gait Profile Score (GPS)
时间窗: immediately after the intervention (gait analysis)
The primary outcome measure is the gait profile score (GPS), which is an overall score calculated from all kinematic parameters (joint rotation angles) of the affected leg and expressed as the deviation from the normal gait cycle in degrees. The outcome of the GPS will be compared between the conventional AFO, and modular customized AFO for each participant and for each group.
次要结局
- Movement Analysis Profile (MAP) and spatial-temporal parameters(immediately after the intervention (gait analysis))
研究者
Beat Göpfert
MEng, EMBA
University of Basel