NCT03668561终止不适用
Evaluation of the Effect of the CALIGALOC Orthosis on Standing and Walking of Hemiparetic Patients With Ankle Varus
University Hospital, Lille2 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2019年2月22日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- 10-meter walk test (in seconds)
研究概览
简要总结
To assess the benefit of an anti-varus ankle foot orthosis (CALIGALOC, Bauerfeind) on gait and balance parameters in hemiparetic patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hemiparesis at > 3 months (whatever the etiology)
- •varus or equinovarus foot disturbing the stance phase of gait
- •Able to walk at least 10m, with or without assistive device
排除标准
- •unable to walk 10m
- •Botulinum toxin injection less than 3 months before inclusion
- •history of neurological or locomotor pathology in addition to the etiology of hemiparesis
- •Severe comprehension troubles
- •Pregnancy
研究组 & 干预措施
Treatment (CALIGALOC)
Experimental
Wearing of the Caligaloc orthosis
干预措施: Caligaloc (Device)
结局指标
主要结局
10-meter walk test (in seconds)
时间窗: comparison between baseline and 15 days
Maximum gait velocity, from a standing start
次要结局
- Assessment of gait temporospatial parameters by GaitRite®(comparison between baseline and 15 days)
- Baropodometric analysis during gait(comparison between baseline and 15 days)
- Gait endurance (2-minute walk test)(comparison between baseline and 15 days)
- Tolerability of the wearing of the Caligaloc orthosis assessed by visual analog scale(at 15 days)
- Assessment of walking function(comparison between baseline and 15 days)
- Posturographic analysis during static upright stance (center of pressure surface)(comparison between baseline and 15 days)
研究者
研究点 (2)
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