适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- FAAM ankle function measure
研究概览
简要总结
The device to be tested (fireflyTM) stimulates the common peroneal nerve and causes the foot to twitch, and has been shown to increase blood flow. The device is also indicated for the treatment of oedema. In this study the investigators intend to assess the use of the device as an adjunctive therapy for people recovering from grade 1 and 2 ankle sprains.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Aged 18 years and over
- •Referred to physiotherapy for treatment of ankle sprain
- •Clinical diagnosed ankle sprain with evidence of swelling
- •Able to understand the Subject Information Sheet and willing to sign the written Informed Consent Form.
- •Able and willing to follow the protocol requirements
排除标准
- •Has an ankle sprain grade 3
- •Evidence of fracture
- •Has a pacemaker
- •Chronic Obesity (BMI Index >40kg/m2).
- •History or signs of previous deep or superficial vein thrombosis/pulmonary embolism.
- •Varicosities, ulceration or erosion around the area of the leg where the study device would be fitted
- •Not able to fit firefly device
结局指标
主要结局
FAAM ankle function measure
时间窗: 1 week
Oedema lower leg
时间窗: 1 week
次要结局
- Ankle proprioception - as assessed by the time that the participant can stand on one leg for with their eyes closed, this will be recorded and repeated three times, the average will be taken(1 week)
- Adverse event rate(1 week)
- VAS Pain score(1 week)
研究者
研究点 (2)
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