Clinical trial NCT03808454: The Effect of Proprioception of Platelet Rich Plasma for Patients With Ankle Sprain
Official title: The Effect of Proprioception of Platelet Rich Plasma for Patients With Ankle Sprain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Ankle Sprain 2Nd Degree
Ankle Sprain 3Rd Degree
Keywords: Platelet rich plasma, proprioception, ankle sprain
Lead sponsor: National Defense Medical Center, Taiwan
Sponsor class: OTHER
Collaborators: name: Tri-Service General Hospital
First posted: 2019-01-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: mean of the distance of ankle movement by the force plate system
timeFrame: 10 min
measure: standard error
timeFrame: 10 min
measure: coefficient of variance
timeFrame: 10 min
Secondary outcomes:
measure: Time Up and Go(TUG)
timeFrame: 15 sec
measure: Visual analogues scale (VAS )
timeFrame: 5 sec
measure: AOFAS Ankle-Hindfoot score
timeFrame: 10 min
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Tri-service General Hospital
Study officials:
affiliation: Department of rehabiliation,TSGH, Taipei, Taiwan
name: Shang-Lin Chiang, PhD
role: STUDY_DIRECTOR
References:
citation: L. Laver, M. R. Carmont, M. O. McConkey, E. Palmanovich, E. Yaacobi, G. Mann, et al.,