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

Ankle Sprain 2Nd Degree Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03808454
• Other study ID #: Tri-Service General Hospital
• Status: Recruiting
• Phase: Phase 4
• Start date: October 1, 2019
• Est. completion date: December 31, 2024

Study information

• Verified date: September 2023
• Source: National Defense Medical Center, Taiwan
• Contact: Shang-Lin Chiang, PhD
• Phone: 8860287923311
• Email: andyyy520[@]yahoo.com.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Ankle Injuries
• Ankle Sprain 2Nd Degree
• Ankle Sprain 3Rd Degree
• Sprains and Strains

Intervention

Drug:
• PRP
The investigators draw 10cc of blood and concentrate the blood to get the platelet rich plasma

Other:
• Rehabilitation
strengthening ex, posture training,...

Combination Product:
• PRP+Rehabilitation
combine PRP and Rehabilitation

Locations

Country	Name	City	State
Taiwan	Tri-service General Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
National Defense Medical Center, Taiwan	Tri-Service General Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (1)

L. Laver, M. R. Carmont, M. O. McConkey, E. Palmanovich, E. Yaacobi, G. Mann, et al.,

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	standard error	evaluated by the parameter of standard error of the distance of ankle movement by the force plate system	10 min
Primary	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	Time Up and Go(TUG)	walking ability	15 sec
Secondary	Visual analogues scale (VAS )	pain level	5 sec
Secondary	AOFAS Ankle-Hindfoot score	function of ankle and foot	10 min