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Table 1 Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) figure showing the enrollment, interventions, and data collection protocols

From: Add-on effect of kinesiotape in patients with acute lateral ankle sprain: a randomized controlled trial

 

STUDY PERIOD

Enrolment

Allocation

Post-allocation

Close-out

TIMEPOINT

Screening

Visit1

Visit2

Visit3

Visit4

Visit5

Visit6

Visit7

Visit8

Visit9

Week

1

5

8

13

27

ENROLMENT

           

Informed consent

X

          

Sociodemographic profile

X

          

Medical history

X

          

Vital signs

X

X

X

X

X

X

X

X

   

Inclusion/exclusioncriteria

X

          

Allocation

 

X

         

INTERVENTIONS

           

Acupuncture treatment

  

X

X

X

X

X

    

Acupuncture and Kinesio taping combination treatment

  

X

X

X

X

X

    

ASSESSMENTS

           

Change of medical history

  

X

X

X

X

X

X

X

X

X

Safety assessment

  

X

X

X

X

X

X

   

Visual Analogue Scale of pain

  

X

   

X

X

   

Foot and Ankle Outcome Score

  

X

   

X

X

   

Edema of ankle sprain

  

X

   

X

X

   

European Quality of Life Five Dimension-Five Level Scale

  

X

   

X

X

  

X

Number of recurrent ankle injuries

       

X

X

X

X