Clincosm LogoSign in Get a demo

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

Sponsor
National Defense Medical Center, Taiwan (Other)
Overall Status
Unknown status
CT.gov ID
NCT03808454
Collaborator
Tri-Service General Hospital (Other)
60
Enrollment
1
Location
3
Arms
35.2
Anticipated Duration (Months)
1.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • 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.

Study Design

Study Type:
Interventional
Anticipated 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 :
Jan 1, 2018
Anticipated Primary Completion Date :
Apr 6, 2020
Anticipated Study Completion Date :
Dec 6, 2020

Arms and Interventions

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,...

Outcome Measures

Primary Outcome Measures

  1. mean of the distance of ankle movement by the force plate system [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 [10 min]

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

  3. coefficient of variance [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) [15 sec]

    walking ability

  2. Visual analogues scale (VAS ) [5 sec]

    pain level

  3. AOFAS Ankle-Hindfoot score [10 min]

    function of ankle and foot

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tri-service General Hospital Taipei Taiwan 115

Sponsors and Collaborators

  • National Defense Medical Center, Taiwan
  • Tri-Service General Hospital

Investigators

  • Study Director: Shang-Lin Chiang, PhD, Department of rehabiliation,TSGH, Taipei, Taiwan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Shang-Lin Chiang, Director, Department of Rehabilitation, National Defense Medical Center, Taiwan
ClinicalTrials.gov Identifier:
NCT03808454
Other Study ID Numbers:
  • Tri-Service General Hospital
First Posted:
Jan 17, 2019
Last Update Posted:
Feb 26, 2020
Last Verified:
Feb 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Shang-Lin Chiang, Director, Department of Rehabilitation, National Defense Medical Center, Taiwan
Platelet rich plasma, proprioception, ankle sprain
Additional relevant MeSH terms:
Sprains and Strains
Ankle Injuries

Study Results

No Results Posted as of Feb 26, 2020