The Effect of Proprioception of Platelet Rich Plasma for Patients With Ankle Sprain
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Oct 2019
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 1, 2019
CompletedFirst Posted
Study publicly available on registry
January 17, 2019
CompletedStudy Start
First participant enrolled
October 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedOctober 2, 2023
September 1, 2023
5.3 years
January 1, 2019
September 29, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (3)
Time Up and Go(TUG)
15 sec
Visual analogues scale (VAS )
5 sec
AOFAS Ankle-Hindfoot score
10 min
Study Arms (3)
Platelet rich plasma (PRP)
EXPERIMENTALPRP injection only
PRP+Rehabilitation
EXPERIMENTALPRP injection combined with rehabilitation
Rehabilitation
ACTIVE COMPARATORRehabilitation treatment only
Interventions
The investigators draw 10cc of blood and concentrate the blood to get the platelet rich plasma
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tri-service General Hospital
Taipei, 115, Taiwan
Related Publications (1)
L. Laver, M. R. Carmont, M. O. McConkey, E. Palmanovich, E. Yaacobi, G. Mann, et al.,
RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Shang-Lin Chiang, PhD
Department of rehabiliation,TSGH, Taipei, Taiwan
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Department of Rehabilitation
Study Record Dates
First Submitted
January 1, 2019
First Posted
January 17, 2019
Study Start
October 1, 2019
Primary Completion
December 31, 2024
Study Completion
December 31, 2024
Last Updated
October 2, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will not share
The investigators don't want to share IPD until the investigators publish it.