The Effect of Proprioception of Platelet Rich Plasma for Patients With Ankle Sprain
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- mean of the distance of ankle movement by the force plate system
研究概览
简要总结
Ankle sprain is a fairly common sports medicine clinic. In Taiwan at least 150,000 to 200,000 people will suffer from ankle sprains every years. Clinicians have been looking for ways to shorten treatment time and reduce discomfort. Platelet Rich Plasma(PRP) is an endogenous therapeutic technology that involved in regenerative medicine due to its potential to stimulate and accelerate tissue healing. PRP can release lots of growth factors like platelet-derived growth factor (PDGF),transforming Growth Factor Beta(TGF-β), vascular endothelial growth factor(VEGF),Epidermal growth factor(EGF) and insulin-like growth factor (IGF). Its use had been based on the theory that increased autologous platelets, that then yield high concentrations of growth factors and other proteins, will lead to increased healing of tendon and soft tissue on a cellular level. In addition, there is no objective evaluation after treatment, so that patients can not provide effective and accurate quantitative feedback. In this study, the investigators divided patients into three groups, respectively, general rehabilitation therapy, autologous PRP injection therapy, autologous PRP injection combined with general rehabilitation therapy.
详细描述
The investigators divided patients into three groups, respectively, general rehabilitation therapy, autologous PRP injection therapy, autologous PRP injection combined with general rehabilitation therapy randomly. The investigators also use the new ankle proprioception evaluation system and evaluation of clinical function after treatment. It is expected to establish another feasible and rapid treatment method for ankle sprain. Combined with high accuracy ankle body defect evaluation method, it is helpful to design proper treatment and rehabilitation strategy in the future so as to improve the rehabilitation of limbs Coordination and control capabilities.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ankle sprain within one months
- •Gr II or Gr III ankle sprain (anterior talus fibular ligament)by sonogram proved
- •could cooperate the examination of the test
排除标准
- •Hemianopsia or hemineglect any brain lesion such as cerebrum of cerebellum involved movement
- •cancer victim
- •pregnant If needed PRP treatment
- •Liver cirrhosis
- •Platelet < 150000/UL
- •Sepsis, Leukemia
- •use anti-coagulation agents
- •under hemodialysis
研究组 & 干预措施
Platelet rich plasma (PRP)
PRP injection only
干预措施: PRP (Drug)
PRP+Rehabilitation
PRP injection combined with rehabilitation
干预措施: PRP+Rehabilitation (Combination Product)
Rehabilitation
Rehabilitation treatment only
干预措施: Rehabilitation (Other)
结局指标
主要结局
mean of the distance of ankle movement by the force plate system
时间窗: 10 min
The proprioception could be evaluated by the parameter of mean of the distance of ankle movement by the force plate system
standard error
时间窗: 10 min
evaluated by the parameter of standard error of the distance of ankle movement by the force plate system
coefficient of variance
时间窗: 10 min
evaluated by the parameter of coefficient of variance of the distance of ankle movement by the force plate system
次要结局
- Time Up and Go(TUG)(15 sec)
- Visual analogues scale (VAS )(5 sec)
- AOFAS Ankle-Hindfoot score(10 min)
研究者
Shang-Lin Chiang
Director, Department of Rehabilitation
National Defense Medical Center, Taiwan