Athletes With Previous Lateral Ankle Sprain(s) Clinical Trial
Official title:
A Randomized Pilot Trial to Evaluate the Preliminary Effect and Safety of Using Spraino® to Prevent Lateral Ankle Sprains in Indoor Sports (The Spraino Pilot Trial)
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 follow-up.
All recruited participants will have a history of lateral ankle sprain in the preceding 24
months prior to the initiation of the trial. Half of the included participants will receive
Spraino® to prevent lateral ankle sprains (intervention group). The other half will receive
no intervention ("do-as-usual" control group). Both groups will be permitted to continue or
initiate any usual care of their choice, except Spraino® in the control group. Short Message
Services (SMS) will be used for registration of injury and exposure.
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 in indoor sports at sub-elite level (handball, basketball, floorball and
badminton) when compared to a "do-as-usual" control group.
It is a randomized controlled pilot trial (Pilot-RCT) with a two-group parallel design and
blinded outcome assessment. The trial will include prospective injury and exposure
registration using a Short Message Services-system (SMS-Track) throughout a 52-week follow-up
period (one calendar year).
It is anticipated that 500 participants, which approximates to 250 in each group, will be
enrolled in the trial. The enrollment process will cease when at least 250 participants have
been allocated to the intervention group. Only athletes participating in indoor sports with a
history of a lateral ankle sprain in the preceding 24 months are eligible for inclusion in
the trial. The participants will be randomized (1:1 allocation ratio) using numbered lots.
The randomization process will ensure stratification for gender, sports discipline and level
of play.
A full trial protocol, based on the "SPIRIT 2013 explanation and elaboration: guidance for
protocols of clinical trials" (Chan et al., 2013) and the "PREPARE Trial guide" (Bandholm et
al., 2017), will be published and made publicly available. The trial report will adhere to
the CONSORT 2010 statement, using the extension for randomized pilot and feasibility trials.
Being an exploratory pilot trial, the study is designed with a flat outcome structure with
multiple evenly valued outcome measures. Thus, no primary and secondary outcome measure
hierarchy exists.
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