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

Primary Purpose

Ankle Sprain 2Nd Degree, Ankle Sprain 3Rd Degree

Status
Recruiting
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
PRP
Rehabilitation
PRP+Rehabilitation
Sponsored by
National Defense Medical Center, Taiwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankle Sprain 2Nd Degree focused on measuring Platelet rich plasma, proprioception, ankle sprain

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tri-service General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Platelet rich plasma (PRP)

PRP+Rehabilitation

Rehabilitation

Arm Description

PRP injection only

PRP injection combined with rehabilitation

Rehabilitation treatment only

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Time Up and Go(TUG)
walking ability
Visual analogues scale (VAS )
pain level
AOFAS Ankle-Hindfoot score
function of ankle and foot

Full Information

First Posted
January 1, 2019
Last Updated
September 29, 2023
Sponsor
National Defense Medical Center, Taiwan
Collaborators
Tri-Service General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03808454
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Defense Medical Center, Taiwan
Collaborators
Tri-Service General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Sprain 2Nd Degree, Ankle Sprain 3Rd Degree
Keywords
Platelet rich plasma, proprioception, ankle sprain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Platelet rich plasma (PRP)
Arm Type
Experimental
Arm Description
PRP injection only
Arm Title
PRP+Rehabilitation
Arm Type
Experimental
Arm Description
PRP injection combined with rehabilitation
Arm Title
Rehabilitation
Arm Type
Active Comparator
Arm Description
Rehabilitation treatment only
Intervention Type
Drug
Intervention Name(s)
PRP
Intervention Description
The investigators draw 10cc of blood and concentrate the blood to get the platelet rich plasma
Intervention Type
Other
Intervention Name(s)
Rehabilitation
Intervention Description
strengthening ex, posture training,...
Intervention Type
Combination Product
Intervention Name(s)
PRP+Rehabilitation
Intervention Description
combine PRP and Rehabilitation
Primary Outcome Measure Information:
Title
mean of the distance of ankle movement by the force plate system
Description
The proprioception could be evaluated by the parameter of mean of the distance of ankle movement by the force plate system
Time Frame
10 min
Title
standard error
Description
evaluated by the parameter of standard error of the distance of ankle movement by the force plate system
Time Frame
10 min
Title
coefficient of variance
Description
evaluated by the parameter of coefficient of variance of the distance of ankle movement by the force plate system
Time Frame
10 min
Secondary Outcome Measure Information:
Title
Time Up and Go(TUG)
Description
walking ability
Time Frame
15 sec
Title
Visual analogues scale (VAS )
Description
pain level
Time Frame
5 sec
Title
AOFAS Ankle-Hindfoot score
Description
function of ankle and foot
Time Frame
10 min

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shang-Lin Chiang, PhD
Phone
8860287923311
Ext
12677
Email
andyyy520@yahoo.com.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Liang-Hsuan Lu, Ms
Phone
8860287923311
Ext
17070
Email
katelinana@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shang-Lin Chiang, PhD
Organizational Affiliation
Department of rehabiliation,TSGH, Taipei, Taiwan
Official's Role
Study Director
Facility Information:
Facility Name
Tri-service General Hospital
City
Taipei
ZIP/Postal Code
115
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Department of Rehabilitation

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The investigators don't want to share IPD until the investigators publish it.
Citations:
Citation
L. Laver, M. R. Carmont, M. O. McConkey, E. Palmanovich, E. Yaacobi, G. Mann, et al.,
Results Reference
result

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

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