| 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 | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Informed consent | X | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Sociodemographic profile | X | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Medical history | X | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Vital signs | X | X | X | X | X | X | X | X | Â | Â | Â |
Inclusion/exclusioncriteria | X | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Allocation | Â | X | Â | Â | Â | Â | Â | Â | Â | Â | Â |
INTERVENTIONS | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Acupuncture treatment | Â | Â | X | X | X | X | X | Â | Â | Â | Â |
Acupuncture and Kinesio taping combination treatment | Â | Â | X | X | X | X | X | Â | Â | Â | Â |
ASSESSMENTS | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Change of medical history | Â | Â | X | X | X | X | X | X | X | X | X |
Safety assessment | Â | Â | X | X | X | X | X | X | Â | Â | Â |
Visual Analogue Scale of pain | Â | Â | X | Â | Â | Â | X | X | Â | Â | Â |
Foot and Ankle Outcome Score | Â | Â | X | Â | Â | Â | X | X | Â | Â | Â |
Edema of ankle sprain | Â | Â | X | Â | Â | Â | X | X | Â | Â | Â |
European Quality of Life Five Dimension-Five Level Scale | Â | Â | X | Â | Â | Â | X | X | Â | Â | X |
Number of recurrent ankle injuries | Â | Â | Â | Â | Â | Â | Â | X | X | X | X |