The Spraino Pilot Trial

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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)

Conditions
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Athletes With Previous Lateral Ankle Sprain(s)

Intervention / Treatment
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* Device: Spraino


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Participants allocated to the intervention group will use Spraino® as a measure to prevent lateral ankle sprains. | Device: Spraino<br>* Participants allocated to the intervention group will use Spraino® as a measure to prevent future lateral ankle sprains during all on-court practice sessions and matches. Spraino® is an adhesive polytetrafluoroethylene (PTFE or Teflon) patch. It is developed with the intent of minimizing lateral shoe- surface friction whenever initial contact is carried out in an inverted position of the ankle joint. Each Spraino® PTFE patch has a minimum durability of 20 hours use and will be provided by the trial sponsor, Spraino® ApS. The participants allocated to the intervention group will receive four pairs of the Spraino® patches via postal service or by hand delivery on a monthly basis, or upon request if material is worn out prematurely during the 52-week trial period.<br>|
| No Intervention: Control<br>Participants allocated to the control group will be a do-as-usual comparator. This implies, that the participants can treat and prevent lateral ankle sprains in any way they wish, except using Spraino®. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lateral ankle sprains | Rate of lateral ankle sprains (continuous) The incidence rate is defined as the number of lateral ankle sprains per 1000 hours of exposure. | 52 weeks | 
| First-time non-contact lateral ankle sprains | Rate of first-time non-contact lateral ankle sprains (continuous) The incidence rate is defined as the number of first-time non-contact lateral ankle sprains per 1000 hours of exposure. | 52 weeks | 
| Time-loss due to first-time non-contact lateral ankle sprains | Time-loss (in number of weeks) due to first-time non-contact lateral ankle sprains per athlete (continuous) | 52 weeks | 
| Severe first-time non-contact lateral ankle sprains | Rate of severe first-time non-contact lateral ankle sprains (continuous) The incidence rate is defined as the number of severe first-time non-contact lateral ankle sprains (≥ 3 weeks with time-loss) per 1000 hours of exposure. | 52 weeks | 
| Recurrent non-contact lateral ankle sprains | Rate of recurrent non-contact lateral ankle sprains (continuous) The incidence rate is defined as the number of recurrent non-contact lateral ankle sprains per 1000 hours of exposure. | 52 weeks | 
| Time-loss due to recurrent non-contact lateral ankle sprains | Time-loss (in number of weeks) due to recurrent non-contact lateral ankle sprains per athlete (continuous) | 52 weeks | 
| Severe recurrent non-contact lateral ankle sprains | Rate of severe recurrent non-contact lateral ankle sprains (continuous) The incidence rate is defined as the number of severe recurrent non-contact lateral ankle sprains (≥ 3 weeks with time-loss) per 1000 hours of exposure. | 52 weeks | 
| First-time lateral ankle sprains | Rate of first-time lateral ankle sprains (continuous) The incidence rate is defined as the summation of both contact and non-contact first-time lateral ankle sprains per 1000 hours of exposure. | 52 weeks | 
| Time-loss due to first-time lateral ankle sprains | Time-loss (in number of weeks) due to first-time lateral ankle sprains per athlete (continuous) | 52 weeks | 
| Severe first-time lateral ankle sprains | Rate of severe first-time lateral ankle sprains (continuous) The incidence rate is defined as the number of severe first-time lateral ankle sprains (≥ 3 weeks with time-loss) per 1000 hours of exposure. | 52 weeks | 
| Recurrent lateral ankle sprains | Rate of recurrent lateral ankle sprains (continuous) The incidence rate is defined as the summation of both contact and non-contact recurrent lateral ankle sprains per 1000 hours of exposure. | 52 weeks | 
| Time-loss due to recurrent lateral ankle sprains | Time-loss (in number of weeks) due to recurrent lateral ankle sprains per athlete (continuous) | 52 weeks | 
| Severe recurrent lateral ankle sprains | Rate of severe recurrent lateral ankle sprains (continuous) The incidence rate is defined as the number of severe recurrent lateral ankle sprains (≥ 3 weeks with time-loss) per 1000 hours of exposure. | 52 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ankle Sprain, Prophylaxis, Indoor Sports, Ligamentous sprain, Prevention