EQUISOCK: New Antiequine for Ankle
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Device Feasibility
研究概览
简要总结
The goal of this experimental study is to test the feasibility and validity of a new orthosis in patients with ankle lesions (external popliteal sciatic nerve or nerve injuries resulting in loss of ankle dorsiflexion) of both sexes and all ages. The main question it aims to answer is:Is the new orthosis a support for ankle stability??Does the new orthosis improve ankle function and patients' quality of life??The control group will be the subjects themselves when wearing their conventional ankle orthosis or without it. Participants must wear the new ankle orthosis for at least one month to assess the effectiveness of the orthosis and evaluate any changes that have occurred in the ankle joint and muscles.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Device Feasibility
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with chronic ankle injuries
- •patients with external popliteal sciatic nerve lesion or nerve injuries resulting in loss of ankle dorsiflexion
- •patients who have already been prescribed an orthosis
- •patients of all ages
排除标准
- •inability to stand actively and stably
- •inability to walk unaided
- •inability to follow instructions
研究组 & 干预措施
EQUISOCK group
Participants must wear the new ankle orthosis during assessments and in their daily lives for at least one month, which is the duration of the study.
干预措施: EQUISOCK (Device)
Other ankle orthosis
Participants must wear the conventional ankle orthosis (and without orthosis) during assessments and in their daily lives, before wear the new one.
干预措施: Other ankle orthosis (Device)
结局指标
主要结局
Device Feasibility
时间窗: Baseline and up to 4 weeks
Device feasibility will be assessed through participants' awareness of the device, as an indicator of its accessibility, visibility, and potential for effective implementation within the target population. A self diary Will be requested
次要结局
- Footprint with a pressure platform(Baseline and up to 4 weeks)
- Ankle function with virtual reality(Baseline and up to 4 weeks)
- Range of motion with Gyko device(Baseline and up to 4 weeks)
研究者
Rocío Llamas-Ramos
Principal Investigator
University of Salamanca