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

Phase 4
Recruiting
Conditions
Ankle Sprain 2Nd Degree
Ankle Sprain 3Rd Degree
Interventions
Combination Product: PRP+Rehabilitation
Other: Rehabilitation
Registration Number
NCT03808454
Lead Sponsor
National Defense Medical Center, Taiwan
Brief Summary

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

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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
60
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Platelet rich plasma (PRP)PRPPRP injection only
PRP+RehabilitationPRP+RehabilitationPRP injection combined with rehabilitation
RehabilitationRehabilitationRehabilitation treatment only
Primary Outcome Measures
NameTimeMethod
mean of the distance of ankle movement by the force plate system10 min

The proprioception could be evaluated by the parameter of mean of the distance of ankle movement by the force plate system

standard error10 min

evaluated by the parameter of standard error of the distance of ankle movement by the force plate system

coefficient of variance10 min

evaluated by the parameter of coefficient of variance of the distance of ankle movement by the force plate system

Secondary Outcome Measures
NameTimeMethod
Time Up and Go(TUG)15 sec

walking ability

Visual analogues scale (VAS )5 sec

pain level

AOFAS Ankle-Hindfoot score10 min

function of ankle and foot

Trial Locations

Locations (1)

Tri-service General Hospital

🇨🇳

Taipei, Taiwan

Tri-service General Hospital
🇨🇳Taipei, Taiwan
Department of Rehabilitation
Contact

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