The Effect of Proprioception of Platelet Rich Plasma for... | NCT03808454

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

NCT03808454

Sponsor

National Defense Medical Center, Taiwan

Status

Unknown status

Last Update Posted

Oct 2, 2023Actual

Enrollment

60Estimated

Phase

Phase 4

Conditions

Ankle Sprain 2Nd Degree
Ankle Sprain 3Rd Degree

Interventions

PRP
Rehabilitation
PRP+Rehabilitation

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2019Actual

Primary Completion Date

Dec 31, 2024Estimated

Completion Date

Dec 31, 2024Estimated

First Submitted Date

Jan 1, 2019

First Submission Date that Met QC Criteria

Jan 16, 2019

First Posted Date

Jan 17, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 29, 2023

Last Update Posted Date

Oct 2, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Shang-Lin Chiang, Director, Department of Rehabilitation, National Defense Medical Center, TaiwanPrincipal Investigator

Lead Sponsor

National Defense Medical Center, TaiwanOTHER

Collaborators

Name	Class
Tri-Service General Hospital (TSGH)	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Platelet rich plasma (PRP)	Experimental	PRP injection only	Drug: PRP
PRP+Rehabilitation	Experimental	PRP injection combined with rehabilitation	Combination Product: PRP+Rehabilitation
Rehabilitation	Active Comparator	Rehabilitation treatment only	Other: Rehabilitation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PRP	Drug	The investigators draw 10cc of blood and concentrate the blood to get the platelet rich plasma	Platelet rich plasma (PRP)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Time Up and Go(TUG)	walking ability	15 sec
Visual analogues scale (VAS )	pain level	5 sec

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Shang-Lin Chiang, PhD	Contact	8860287923311	12677	andyyy520@yahoo.com.tw
Liang-Hsuan Lu, Ms	Contact	8860287923311	17070	katelinana@gmail.com

Overall Officials

Name	Affiliation	Role
Shang-Lin Chiang, PhD	Department of rehabiliation,TSGH, Taipei, Taiwan	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tri-service General Hospital	Recruiting	Taipei		115	Taiwan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
	Result	L. Laver, M. R. Carmont, M. O. McConkey, E. Palmanovich, E. Yaacobi, G. Mann, et al.,

ID	Term
D007869	Leg Injuries
D014947	Wounds and Injuries

ID	Term
D000359	Aftercare
D003266	Continuity of Patient Care
D005791	Patient Care
D013812	Therapeutics