Status:
TERMINATED
The Spraino Pilot Trial
Lead Sponsor:
Spraino
Collaborating Sponsors:
Copenhagen University Hospital, Hvidovre
Aalborg University
Conditions:
Athletes With Previous Lateral Ankle Sprain(s)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This pilot study will establish the preliminary effect and safety of using Spraino® to prevent lateral ankle sprains amongst athletes competing in indoor sports at sub-elite level, with a one-year fol...
Detailed Description
The purpose of this exploratory trial (named "The Spraino Pilot Trial") is to establish the preliminary effect and safety of using Spraino® to prevent lateral ankle sprains amongst athletes competing ...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Participant is ≥ 18 years old at commencement of trial.
- Participant can read, speak and understand Danish.
- Participant can receive and reply to texts on a cell phone using Short Message Services (SMS).
- Participant performs indoor sports (Handball, basketball, floorball orbadminton) in a sub-elite level team with ≥ 2 weekly practice sessions.
- Participant has incurred ≥ 1 lateral ankle sprain injury in the preceding 24 months.
- Participant has returned to play at commencement of the trial.
Exclusion
Key Trial Info
Start Date :
October 19 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 5 2018
Estimated Enrollment :
510 Patients enrolled
Trial Details
Trial ID
NCT03311490
Start Date
October 19 2017
End Date
October 5 2018
Last Update
August 30 2019
Active Locations (2)
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1
Physical Activity and Human Performance, Center for Sensory Motor Interaction, Department of Health Science and Technology, Aalborg University, Denmark
Aalborg, Denmark, 9220
2
Physical Medicine and Rehabilitation Research-Copenhagen (PMR-C), Clinical Research Centre, Amager-Hvidovre Hospital, Copenhagen University
Hvidovre, Denmark, 2650