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

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.

Study Overview

• Status: Recruiting
• Conditions: Ankle Sprain 2Nd Degree; Ankle Sprain 3Rd Degree
• Intervention / Treatment: Drug: PRP; Combination product: PRP+Rehabilitation; Other: Rehabilitation

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Shang-Lin Chiang, PhD; Phone Number: 12677 8860287923311; Email: andyyy520@yahoo.com.tw
• Study Contact Backup: Name: Liang-Hsuan Lu, MS; Phone Number: 17070 8860287923311; Email: katelinana@gmail.com

Study Locations

• Taiwan
  • Taipei, Taiwan, 115
    • Recruiting
    • Tri-Service General Hospital
    • Contact: Department of Rehabilitation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / 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,...

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time Up and Go(TUG)	walking ability	15 sec
Visual analogues scale (VAS )	pain level	5 sec
AOFAS Ankle-Hindfoot score	function of ankle and foot	10 min

Collaborators and Investigators

• Sponsor: National Defense Medical Center, Taiwan
• Collaborators: Tri-Service General Hospital
• Investigators: Study Director: Shang-Lin Chiang, PhD, Department of rehabiliation,TSGH, Taipei, Taiwan

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: January 1, 2019
• First Submitted That Met QC Criteria: January 16, 2019
• First Posted (Actual): January 17, 2019

Study Record Updates

• Last Update Posted (Actual): October 2, 2023
• Last Update Submitted That Met QC Criteria: September 29, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Platelet rich plasma, proprioception, ankle sprain
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Sprains and Strains; Ankle Injuries
• Other Study ID Numbers: Tri-Service General Hospital

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The investigators don't want to share IPD until the investigators publish it.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No