The Effect of Proprioception of Platelet Rich Plasma for Patients With Ankle Sprain

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Effect of Proprioception of Platelet Rich Plasma for Patients With Ankle Sprain

Conditions
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Ankle Sprain 2Nd Degree, Ankle Sprain 3Rd Degree

Intervention / Treatment
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* Drug: PRP
* Other: Rehabilitation
* Combination Product: PRP+Rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ankle sprain within one months Gr II or Gr III ankle sprain (anterior talus fibular ligament)by sonogram proved MMSE≥23 could cooperate the examination of the test Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Platelet rich plasma (PRP)<br>PRP injection only | Drug: PRP<br>* The investigators draw 10cc of blood and concentrate the blood to get the platelet rich plasma<br>|
| Experimental: PRP+Rehabilitation<br>PRP injection combined with rehabilitation | Combination Product: PRP+Rehabilitation<br>* combine PRP and Rehabilitation<br>|
| Active Comparator: Rehabilitation<br>Rehabilitation treatment only | Other: Rehabilitation<br>* strengthening ex, posture training,...<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean of the distance of ankle movement by the force plate system | The proprioception could be evaluated by the parameter of mean of the distance of ankle movement by the force plate system | 10 min | 
| standard error | evaluated by the parameter of standard error of the distance of ankle movement by the force plate system | 10 min | 
| coefficient of variance | evaluated by the parameter of coefficient of variance of the distance of ankle movement by the force plate system | 10 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time Up and Go(TUG) | walking ability | 15 sec | 
| Visual analogues scale (VAS ) | pain level | 5 sec | 
| AOFAS Ankle-Hindfoot score | function of ankle and foot | 10 min | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Platelet rich plasma, proprioception, ankle sprain