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

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ClinicalTrials.gov Identifier: NCT03808454
Recruitment Status : Recruiting
First Posted : January 17, 2019
Last Update Posted : August 21, 2019
Sponsor:
Collaborator:
Tri-Service General Hospital
Information provided by (Responsible Party):
Shang-Lin Chiang, 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.

Condition or disease Intervention/treatment Phase
Ankle Sprain 2Nd Degree Ankle Sprain 3Rd Degree Drug: PRP Other: Rehabilitation Combination Product: PRP+Rehabilitation Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Proprioception of Platelet Rich Plasma for Patients With Ankle Sprain
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : December 6, 2019
Estimated Study Completion Date : December 6, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Platelet rich plasma (PRP)
PRP injection only
Drug: PRP
The investigators draw 10cc of blood and concentrate the blood to get the platelet rich plasma

Experimental: PRP+Rehabilitation
PRP injection combined with rehabilitation
Combination Product: PRP+Rehabilitation
combine PRP and Rehabilitation

Active Comparator: Rehabilitation
Rehabilitation treatment only
Other: Rehabilitation
strengthening ex, posture training,...




Primary Outcome Measures :
  1. mean of the distance of ankle movement by the force plate system [ Time Frame: 10 min ]
    The proprioception could be evaluated by the parameter of mean of the distance of ankle movement by the force plate system

  2. standard error [ Time Frame: 10 min ]
    evaluated by the parameter of standard error of the distance of ankle movement by the force plate system

  3. coefficient of variance [ Time Frame: 10 min ]
    evaluated by the parameter of coefficient of variance of the distance of ankle movement by the force plate system


Secondary Outcome Measures :
  1. Time Up and Go(TUG) [ Time Frame: 15 sec ]
    walking ability

  2. Visual analogues scale (VAS ) [ Time Frame: 5 sec ]
    pain level

  3. AOFAS Ankle-Hindfoot score [ Time Frame: 10 min ]
    function of ankle and foot



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03808454


Contacts
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Contact: Shang-Lin Chiang, PhD 8860287923311 ext 12677 andyyy520@yahoo.com.tw
Contact: Liang-Hsuan Lu, Ms 8860287923311 ext 17070 katelinana@gmail.com

Locations
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Taiwan
Tri-service General Hospital Recruiting
Taipei, Taiwan, 115
Contact: Department of Rehabilitation         
Sponsors and Collaborators
National Defense Medical Center, Taiwan
Tri-Service General Hospital
Investigators
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Study Director: Shang-Lin Chiang, PhD Department of rehabiliation,TSGH, Taipei, Taiwan

Publications of Results:
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Responsible Party: Shang-Lin Chiang, Director, Department of Rehabilitation, National Defense Medical Center, Taiwan
ClinicalTrials.gov Identifier: NCT03808454     History of Changes
Other Study ID Numbers: Tri-Service General Hospital
First Posted: January 17, 2019    Key Record Dates
Last Update Posted: August 21, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The investigators don't want to share IPD until the investigators publish it.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shang-Lin Chiang, National Defense Medical Center, Taiwan:
Platelet rich plasma, proprioception, ankle sprain
Additional relevant MeSH terms:
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Sprains and Strains
Ankle Injuries
Wounds and Injuries
Leg Injuries