ORLINT & ORLEXT: New Orthosis for the Lateral Knee Ligaments
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 lateral ligament knee lesions of both sexes and older than 18 years old. The main question it aims to answer is:
Is the new orthosis a support for knee stability?? Does the new orthosis improve knee function and patients' quality of life??
The control group will be the subjects themselves when wearing their conventional knee orthosis or without it.
Participants must wear the new knee orthosis for at least one month to assess the effectiveness of the orthosis and evaluate any changes that have occurred in the knee 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
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with chronic knee injuries
- •patients who have already been prescribed an orthosis
- •patients older than 18 years old
排除标准
- •inability to stand actively and stably
- •inability to walk unaided
研究组 & 干预措施
Orlint-Orlext orthosis group
Participants must wear the new knee orthosis during assessments and in their daily lives for at least one month, which is the duration of the study.
干预措施: Orlint-Orlext orthosis device (Device)
Conventional orthesis group
Participants must wear the conventional knee orthosis (a without orthosis) during assessments and in their daily lives, before wear the new one.
干预措施: Conventional orthosis device (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
- Knee function with virtual reality(Baseline and up to 4 weeks)
- Range of motion with a Gyko device(Baseline and up to 4 weeks)
- Footprint with a pressure platform(Baseline and up to 4 weeks)
研究者
Rocío Llamas-Ramos
Principal Investigator
University of Salamanca