The Spraino Pilot Trial

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.

Study Overview

• Status: Terminated
• Conditions: Athletes With Previous Lateral Ankle Sprain(s)
• Intervention / Treatment: Device: Spraino

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 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.

• Study Type: Interventional
• Enrollment (Actual): 510
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aalborg, Denmark, 9220
    • Physical Activity and Human Performance, Center for Sensory Motor Interaction, Department of Health Science and Technology, Aalborg University, Denmark
  • Hvidovre, Denmark, 2650
    • Physical Medicine and Rehabilitation Research-Copenhagen (PMR-C), Clinical Research Centre, Amager-Hvidovre Hospital, Copenhagen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Participants allocated to the intervention group will use Spraino® as a measure to prevent lateral ankle sprains.	Device: Spraino; 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.
No Intervention: Control; 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?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse effects from using Spraino®	Reports of adverse events in the intervention group (binary) All adverse events will be registered while the participants are enrolled in the trial. Adverse events will be reported as type and number of events. The included participants will be encouraged to report any adverse events related to the use of Spraino® to the trial hotline.	52 weeks
Fear of re-injury	Fear of lateral ankle sprain re-injury (continuous) Change in fear of re-injury from pre- to post-trial intervention period. Fear of re-injury is scored on a numeric rating scale from 0 - 100 (0 = Extremely fear full, 100 = No fear at all)	52 weeks
Ankle pain	Ankle pain (continuous) Change in ankle pain from pre- to post-trial intervention period. Ankle pain is scored on a numeric rating scale from 0 - 10 (0 = No pain at all, 10 = Extremely painful)	52 weeks

Collaborators and Investigators

• Sponsor: Spraino
• Collaborators: Aalborg University; Copenhagen University Hospital, Hvidovre; Metropolitan University College; The Copenhagen Center for Health Technology (CACHET)
• Investigators: Principal Investigator: Filip G Lysdal, MSc, Center for Sensory Motor Interaction, Department of Health Science and Technology, Aalborg University, Denmark; Study Director: Kristian Thorborg, PhD, Physical Medicine and Rehabilitation Research-Copenhagen (PMR-C), Clinical Research Centre, Amager-Hvidovre Hospital, Copenhagen University, Hvidovre, Denmark; Study Chair: Thomas Q Bandholm, PhD, Physical Medicine and Rehabilitation Research-Copenhagen (PMR-C), Clinical Research Centre, Amager-Hvidovre Hospital, Copenhagen University, Hvidovre, Denmark; Study Chair: Eamonn Delahunt, PhD, School of Public Health, Physiotherapy and Sports Science, University College Dublin, Dublin, Ireland

Publications and helpful links

General Publications

• Chan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, Hrobjartsson A, Schulz KF, Parulekar WR, Krleza-Jeric K, Laupacis A, Moher D. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013 Jan 8;346:e7586. doi: 10.1136/bmj.e7586.
• Bandholm T, Christensen R, Thorborg K, Treweek S, Henriksen M. Preparing for what the reporting checklists will not tell you: the PREPARE Trial guide for planning clinical research to avoid research waste. Br J Sports Med. 2017 Oct;51(20):1494-1501. doi: 10.1136/bjsports-2017-097527. Epub 2017 Sep 7. No abstract available.
• Lysdal FG, Bandholm T, Tolstrup JS, Clausen MB, Mann S, Petersen PB, Gronlykke TB, Kersting UG, Delahunt E, Thorborg K. Does the Spraino low-friction shoe patch prevent lateral ankle sprain injury in indoor sports? A pilot randomised controlled trial with 510 participants with previous ankle injuries. Br J Sports Med. 2021 Jan;55(2):92-98. doi: 10.1136/bjsports-2019-101767. Epub 2020 Aug 12.

Helpful Links

• SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials.
• Preparing for what the reporting checklists will not tell you: the PREPARE Trial guide for planning clinical research to avoid research waste.

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2017
• Primary Completion (Actual): October 5, 2018
• Study Completion (Actual): October 5, 2018

Study Registration Dates

• First Submitted: October 11, 2017
• First Submitted That Met QC Criteria: October 11, 2017
• First Posted (Actual): October 17, 2017

Study Record Updates

• Last Update Posted (Actual): August 30, 2019
• Last Update Submitted That Met QC Criteria: August 29, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Prevention; Prophylaxis; Ankle Sprain; Indoor Sports; Ligamentous sprain
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Sprains and Strains; Ankle Injuries
• Other Study ID Numbers: 4559

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No