NCT03311490

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 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
510

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 11, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 17, 2017

Completed
2 days until next milestone

Study Start

First participant enrolled

October 19, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 5, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2018

Completed
Last Updated

August 30, 2019

Status Verified

August 1, 2019

Enrollment Period

12 months

First QC Date

October 11, 2017

Last Update Submit

August 29, 2019

Conditions

Athletes With Previous Lateral Ankle Sprain(s)

Keywords

Ankle SprainProphylaxisIndoor SportsLigamentous sprainPrevention

Outcome Measures

Primary Outcomes (13)

  • 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 Outcomes (3)

  • Adverse effects from using Spraino®

    52 weeks

  • Fear of re-injury

    52 weeks

  • Ankle pain

    52 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

Participants allocated to the intervention group will use Spraino® as a measure to prevent lateral ankle sprains.

Device: Spraino

Control

NO INTERVENTION

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®.

Interventions

SprainoDEVICE

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.

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Physical Activity and Human Performance, Center for Sensory Motor Interaction, Department of Health Science and Technology, Aalborg University, Denmark

Aalborg, 9220, Denmark

Location

Physical Medicine and Rehabilitation Research-Copenhagen (PMR-C), Clinical Research Centre, Amager-Hvidovre Hospital, Copenhagen University

Hvidovre, 2650, Denmark

Location

Related Publications (3)

  • 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.

    PMID: 23303884BACKGROUND

  • 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.

    PMID: 28882839BACKGROUND

  • 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.

    PMID: 32796016DERIVED

Related Links

MeSH Terms

Conditions

Ankle Injuries

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Study Officials

  • Filip G Lysdal, MSc

    Center for Sensory Motor Interaction, Department of Health Science and Technology, Aalborg University, Denmark

    PRINCIPAL INVESTIGATOR

  • Kristian Thorborg, PhD

    Physical Medicine and Rehabilitation Research-Copenhagen (PMR-C), Clinical Research Centre, Amager-Hvidovre Hospital, Copenhagen University, Hvidovre, Denmark

    STUDY DIRECTOR

  • 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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2017

First Posted

October 17, 2017

Study Start

October 19, 2017

Primary Completion

October 5, 2018

Study Completion

October 5, 2018

Last Updated

August 30, 2019

Record last verified: 2019-08

Locations

DK(2)